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Job Description ABOUT US: Ethos Risk Services is a leading insurance claims investigation and medical management company, specializing in surveillance and fraud detection. At the forefront of, we provide accurate data and actionable insights that translate into better decision-making for our clients. To learn more, visit: https://ethosrisk.com/about-us/ JOB SUMMARY: Have you ever thought about becoming a Private Investigator? Are you ready to kick-start your career in a rapidly growing industry? Want to get paid to learn how to investigate fraud and conduct covert surveillance in the real world? Our Full-Time Entry-Level Field Investigator position will help launch your career by providing you with an industry leading FULLY PAID Investigator Training Program - no prior experience necessary! KEY RESPONSIBILITIES: • Case Preparation: Conduct preliminary investigations using social media and analyzing database research., • Field Surveillance: Perform covert surveillance from your vehicle by tracking and capturing high-quality video evidence of surveillance targets., • Report Writing: Draft detailed and court-ready investigative reports summarizing activity and key findings., • Documentation: Finalize case files by submitting case reports and uploading video footage via personal laptop at the end of the day., • Communication: Work closely with field supervisor, receiving regular guidance and mentorship. QUALIFICATIONS: • Driver's License: Active driver's license that is not currently suspended or revoked., • Personal Vehicle: A well-maintained vehicle that is always reliable (preferably with tinted windows). Proof of auto insurance coverage is required., • Travel Expectations: While we aim to keep assignments within a reasonable drive of your residence, occasional further travel and overnight stays (covered by the company) may be required., • Technology: A reliable laptop, cell phone, and internet service are needed for communication and administrative tasks., • Required Skills: Strong computer & internet proficiency. Excellent communication, verbal & writing skills. WHAT WE OFFER: • Paid Investigator Training Program: Fully paid training program led by industry experts with ongoing development and support. Initial training will be held via virtual classroom then transition into on-the-job training., • Paid Licensing: We pay for all your licensing fees! Our licensing team will guide you through the process of acquiring all investigator licensing to ensure a smooth process., • Surveillance Equipment: We will provide you with necessary surveillance equipment. After a year of employment, it is yours to keep!, • Pay Increases & Milage Reimbursement: There are several performance milestones within your training & first year of employment that will reward you with pay increases. Additionally, we offer a mileage reimbursement program., • Health Insurance/Retirement: Medical, Dental Vision, Life/Disability Insurance + 401k WORKING CONDITIONS: • Most surveillance cases start at 6:00AM. End time can vary depending on activity and a typical workday can vary from 3-12 hours., • Weekends/holidays are common workdays as claimants are more likely to be active., • This is an independent role often requiring long hours alone in your vehicle, regardless of weather conditions., • Must remain alert with no external distractions, ready to use videography equipment to document subjects. Ethos Risk Services is an equal opportunity employer that does not discriminate on the basis of religious creed, sex, national origin, race, veteran status, disability, age, marital status, color or sexual orientation or any other characteristic. A background check will be conducted, in accordance to the local state law and regulations. Job Posted by ApplicantPro

Job Description About C4 Therapeutics: C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com. Job Summary C4 Therapeutics is seeking an initiative-taking Clinical Operations professional to lead the successful execution of assigned clinical trial(s) in oncology from First in Human through Phase III. The Clinical Trial Manager will be responsible and accountable for planning and execution of day-to-day study operations including leading the cross-functional study core team, representing C4T in CRO study team meetings (and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs). This is a hybrid role with expected regular presence at our Watertown, MA office. Your Role • Lead the execution of the day-to-day operational aspects of clinical study(ies) from protocol concept through clinical study report ensuring all trial deliverables are met according to established timelines, goals, budget, and quality standards., • Collaborate with cross-functional team members on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s)., • Establish study timelines in collaboration with internal stakeholders and CRO partners and ensure development and accurate reporting of study metrics., • Able to make recommendations and decisions regarding operational strategies to support study objectives., • In collaboration with the Clinical Operations leadership, develop, manage, and track clinical trial budgets including providing ongoing reporting and forecasting to finance (inclusive of site budget review and approval, vendor budget review and approval, and third-party vendor invoice review)., • Manage the cross-functional study team and CRO/vendor(s) related to all aspects of clinical trial operations and continuously assess operational performance through carefully designed performance and quality indicators., • Actively participate in training, and onboarding of study team members., • Lead the identification, RFP/bid defense, evaluation, and selection of CRO/third party vendors., • Develop strong relationships with Investigators and site staff as applicable., • Manage issues and risks, including concise escalation and reporting to Clinical Operations leadership and other appropriate cross-functional team members., • Support and/or lead preparation for Safety Review Committee (PI) Meetings, Investigator and/or Study Coordinator Meetings, Dose Escalation Meetings; may present content as needed., • Contribute to the development of study documents including but not limited to the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, Case Report forms, responses to questions from IRBs and Ethics Committees, clinical sections of IND, CTAs, third party vendor manuals, study plans, and study guidelines/tools/trackers., • Perform and contribute to clinical data cleaning as part of cross-functional data review team., • Supporting protocol deviation identification, processing, categorization, and documentation., • Contribute to Clinical Operations and organizational initiatives to build and optimize business procedures, tools, and guidance., • Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local regulations., • Represent Clinical Operations to internal and external stakeholders including key opinion/thought leaders. Your Background Required: • A Bachelor’s Degree in health/life sciences or related field, with a minimum of five years of progressive clinical operations experience, including trial management across phases of development at a pharmaceutical or biotechnology sponsor, serving as a primary point of contact for CROs and third-party vendors., • Demonstrated knowledge of clinical operations methodologies, FDA Regulations, ICH/GCP guidelines in clinical trials, and related organizational, project management, and leadership capabilities., • Demonstrated experience with contributing to clinical operations strategy and developing and/or input into key clinical trial plans., • Ability to communicate and collaborate in an open and clear manner with varied stakeholders, listening effectively and inviting response and discussion with internal partners and external service providers., • Demonstrated effective problem-solving, and risk management to prevent and overcome complex safety and compliance related issues during clinical study implementation. Preferred: • Experience with oncology clinical trial management and/or global clinical trials. Compensation The base pay range for this position at commencement of employment is expected to be between $138,566.00 and $153,118.00 annually; however, base pay offered may vary depending on multiple individualized factors, including job-related knowledge, skills, and experience. C4 Therapeutics is an Equal Opportunity Employer.

Job DescriptionCompany Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview We are seeking a highly motivated Associate Director of Data Science within Rhythm's Research group and the Data Sciences Team in support of our clinical, regulatory, and scientific objectives in the rare neuroendocrine/obesity/metabolic disease. The successful candidate will have a strong background in biostatistics, genetics, and data analytics, and will be responsible for implementing advanced AI data models, predictive tools, and integrative analyses across the obesity and metabolic disease therapeutic areas. A core focus of this position will be the development and implementation of algorithmic phenotyping approaches using electronic medical records (EMR) and real-world datasets, enabling robust patient stratification, cohort definition, and integration with genomics and biomarker data. This position is ideal for a technically strong investigator who thrives in a fast-paced environment and is motivated to apply and scale high-impact data science infrastructure alongside a growing team. Responsibilities and Duties • Design and deploy AI-driven, agent-based phenotyping pipelines that leverage EMR/EHR and real-world data to define disease cohorts, endpoints, and longitudinal outcomes., • Develop scalable approaches for cohort identification, feature extraction, and phenotype validation, including rule-based and machine learning methods., • Maintain high-throughput rare variant curation and classification models., • Execute the design, development, and deployment of data analysis pipelines, statistical models, and predictive tools to support Genetics-led programs., • Lead hands-on integration of clinical, EMR, genomics, and biomarker datasets, enabling multi-modal analyses., • Build and maintain reproducible workflows for data ingestion, harmonization (e.g., coding systems, ontologies), QC, and analysis (SQL, Python, R)., • Apply statistical genetics and advanced analytics to link phenotypic definitions with genetic signals, including rare variant analyses., • Drive improvements in data infrastructure and phenotyping frameworks to support team expansion and increased dataset complexity. Qualifications and Skills • Ph.D. in Biostatistics, Computational Biology, Genetics, Data Science, or related quantitative field., • ~5+ years of relevant experience in biotechnology, pharmaceuticals, or healthcare analytics., • Experience with neuroendocrine, obesity/metabolic-related biology and datasets., • Experience applying machine learning and AI models to real-world and clinical datasets, including model development, evaluation, and deployment in production or near-production settings., • Experience developing or utilizing AI-driven agents/workflows to automate data extraction, phenotyping, analysis, or knowledge generation tasks., • Strong hands-on expertise in SQL, Python, and R, with experience building production-quality data pipelines., • Experience with cloud computing and storage environments including AWS, GCP, Snowflake., • Demonstrated experience with variant calling pipelines, variant interpretation and ACMG rare variant classification., • Demonstrated experience in EMR/EHR and real-world data analysis (e.g., UK Biobank, All of Us) including cohort building and longitudinal data modeling., • Proven track record in algorithmic phenotyping, including use of coding systems (ICD, CPT, SNOMED), clinical ontologies, and feature engineering., • Familiarity with broader bioinformatics/multi-omics methodologies including RNA-seq, methylation analysis, long-read sequencing would be advantageous., • Strong problem-solving skills and ability to operate independently in a fast-paced, execution-focused environment., • Excellent communication skills with the ability to clearly present complex analytical outputs to technical stakeholders. This role can be remote or based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel. More about Rhythm We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are: • We are committed to advancing scientific understanding to improve patients’ lives, • We are inspired to tackle tough challenges and have the courage to ask bold questions, • We are eager to learn and adapt, • We believe collaboration and ownership are foundational for our success, • We value the unique contribution each individual brings to furthering our mission Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law. Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts. Powered by JazzHR SaCBI7MX9s

Job DescriptionCompany Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview Rhythm seeks an experienced and highly motivated mid-level (5-8 years) attorney with a strong life sciences background, experience providing legal support to clinical operations, and contract drafting and negotiation experience with the agreements and documentation required to support global clinical trials, to join its Legal & Compliance Department in its Boston office. The successful candidate will be proficient in preparing, reviewing, negotiating and advising business clients on agreements and documentation required to support clinical operations, including confidentiality agreements, research and development agreements, clinical trial agreements, master service agreements, statements of work, informed consent forms, material transfer agreements, service agreements, and other clinical trial agreements and documentation. This position will report to the Assistant General Counsel, work extensively with Rhythm’s clinical operations team and be a key member of an agile Legal & Compliance team committed to being a strong business partner. This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. Responsibilities and Duties • Provide leadership and management for clinical trial contracting processes, day-to-day advice and review of contracts with Clinical Research Organizations (CROs) and other clinical trial vendors and clinical trial sites, liaising with senior leaders to manage and escalate issues and working cross-functionally and within the Legal & Compliance Department to ensure streamlined clinical trial contracts review and consistency in compliance with applicable policies and process for the Contract Lifecycle Management platform (CLM)., • Draft, review, and negotiate confidentiality agreements, research and development agreements, clinical trial agreements, master service agreements, statements of work, informed consent forms, material transfer agreements, license agreements, vendor agreements, service agreements, and other clinical trial agreements and documentation., • Provide leadership and management for the Company’s CLM with respect to clinical agreements with assistance from other members of the Legal & Compliance team, with a focus on developing playbooks, templates and standard terms and conditions and processes for clinical trial agreements and documentation, including incorporating the use of AI tools to improve efficiencies and effectiveness in the contracting process., • Advise business leaders on strategies and tactics in a way that advances the company's business objectives while addressing legal risks and protecting the company's integrity and reputation., • Proactively identify legal and compliance risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals., • Advise on other legal matters that arise across various functions within the company., • Manage outside counsel as needed in connection with executing above responsibilities and duties., • Contribute to other projects and areas, which may include research and development, clinical trials, manufacturing or commercial and medical matters, as determined in consultation with other members of the Legal & Compliance team.Qualifications and Skills, • Law degree from an ABA law school and current admission to the bar., • Typically requires 5-8 years of experience in a large law firm, biotech/pharma company, or government agency practicing law and supporting clinical trials, or the equivalent combination of education and experience., • Broad understanding of the life sciences industry and the types of contracts and issues that arise within clinical operations, including a familiarity with FDA rules and regulations related to clinical trials and development of pharmaceutical products., • Substantial experience drafting, negotiating and processing clinical trial contracts with CROs and clinical trial sites and investigators as well as experience or, in the absence of demonstrated experience, a willingness and aptitude for playing a leading role in the oversight of clinical contracting processes and the Company’s CLM., • The ideal candidate will have demonstrated expertise advising on the legal, regulatory, and operational aspects of global clinical trials, including clinical trial agreements, CRO and investigator contracting, informed consent, data governance, and cross-border research activities. Strong knowledge of applicable global regulatory requirements and quality standards, including FDA and GCP requirements, is fundamental, with a preference for candidates with a solid understanding of the impact of global privacy and data protection laws on clinical operations., • The ideal candidate will have demonstrated experience and the ability to provide practical, risk-based guidance to support compliant and efficient clinical development programs., • Outstanding communication, with strong ability to communicate across various functions., • Highly collaborative, with excellent judgment and interpersonal skills and the ability to work in a fast-paced, high-growth environment., • Expert ability to constructively counsel and influence clients to take appropriate actions and make complex decisions., • Capacity to simultaneously handle a variety of complex legal matters with minimal guidance., • Demonstrable experience taking ownership of issues and providing timely, actionable advice., • Exceptional written, organization, and presentation skills. This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel. The expected salary range for this position is $200,000 - $340,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units. More about Rhythm We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are: • We are committed to advancing scientific understanding to improve patients’ lives, • We are inspired to tackle tough challenges and have the courage to ask bold questions, • We are eager to learn and adapt, • We believe collaboration and ownership are foundational for our success, • We value the unique contribution each individual brings to furthering our mission Inherent in our core values is the commitment to act ethically and with integrity in all we do. Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law. Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts. Powered by JazzHR QpqwfpVCKO

Job Description Position Summary: TScan is seeking a highly motivated and detail-oriented Clinical Scientist with deep expertise in clinical data management and data review to support the execution of our oncology cell therapy clinical programs. This unique role sits at the intersection of Clinical Development, Clinical Operations, Data Management, and Biostatistics serving as a critical driver of data quality, data integrity, and clinical insight generation. The Clinical Scientist will be responsible for leading ongoing clinical data review activities, developing data review strategies, identifying and resolving data issues, and ensuring high-quality clinical datasets are available to support safety reviews, regulatory submissions, and clinical decision-making. The successful candidate will possess a strong scientific background combined with hands-on experience in clinical data management, EDC systems, data visualization tools, and cross-functional collaboration. This position offers an opportunity to play a highly visible role in advancing innovative TCR-T therapies through clinical development while helping establish best-in-class data review and clinical science processes. Key Responsibilities Clinical Data Review & Oversight • Serve as the clinical lead for ongoing data review activities across TScan clinical studies., • Develop and execute comprehensive data review plans to ensure timely identification and resolution of data discrepancies, trends, and potential safety signals., • Review patient-level clinical data to assess completeness, consistency, protocol compliance, and medical relevance., • Partner with Clinical Operations, Data Management, Medical, Pharmacovigilance, and Biostatistics to drive data quality and readiness., • Lead cross-functional data review meetings and track resolution of key data issues. Clinical Science & Data Interpretation • Analyze and interpret emerging clinical, safety, efficacy, and biomarker data to support study conduct and decision-making., • Support data cleaning efforts for interim analyses, data monitoring committee reviews, and regulatory submissions., • Contribute to clinical narratives, safety analyses, data listings review, and study reports., • Collaborate with translational and biomarker teams to integrate clinical and correlative data insights. Data Management Collaboration • Partner closely with Data Management to review CRFs, edit checks, data validation plans, and data review specifications., • Provide clinical input into database design, study builds, and data collection strategies., • Support UAT testing of EDC systems and associated clinical technologies., • Review data transfer specifications and external vendor data integration processes., • Ensure data review activities align with CDISC standards and regulatory expectations. Clinical Development Support • Contribute to protocol development, endpoint definitions, and data collection strategies., • Participate in study team meetings and provide clinical science expertise throughout study execution., • Support preparation of clinical study reports (CSRs), regulatory documents, investigator brochures, and publications., • Assist with inspection and audit readiness activities. Process Improvement & Innovation • Develop and implement innovative approaches for ongoing clinical data surveillance and risk-based data review., • Leverage data visualization tools and analytics platforms to enhance clinical data review efficiency., • Contribute to the development of clinical data review SOPs, work instructions, and best practices., • Help establish scalable processes to support growth of TScan's clinical portfolio. Qualifications Education • Advanced degree (PharmD, PhD, MS, MPH, or equivalent) in a life sciences, clinical research, or related field preferred., • Bachelor's degree with significant relevant experience may be considered. Experience • 5–8+ years of experience in clinical development, clinical science, data management, or related functions within biotechnology, pharmaceutical, or CRO environments., • Demonstrated experience performing ongoing clinical data review in oncology or advanced therapy clinical trials., • Experience working closely with Data Management and Biostatistics teams., • Experience supporting early- and/or late-stage clinical trials., • Oncology, immuno-oncology, cell therapy, CAR-T, TCR-T, or hematology experience strongly preferred. Technical Skills • Strong understanding of clinical trial conduct, GCP, ICH guidelines, and regulatory requirements., • Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform)., • Experience using clinical data review and visualization tools such as Spotfire, Tableau, JReview, SAS, or similar platforms., • Familiarity with CDISC standards (SDTM, ADaM) and clinical database structures., • Strong analytical and problem-solving skills with the ability to interpret complex clinical datasets., • Understanding of external data sources, including laboratory, imaging, biomarker, and pharmacokinetic data. Leadership & Collaboration Competencies • Strong scientific curiosity and attention to detail., • Ability to synthesize complex clinical data into actionable insights., • Excellent communication and presentation skills., • Proven ability to work effectively in highly cross-functional teams., • Comfortable operating in a fast-paced, evolving biotechnology environment., • Strong organizational skills with the ability to manage multiple priorities simultaneously. About TScan: TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases. Do YOU have the anatomy of a TScanner? Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today. EEO Statement TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter. Pay Range: $145,000-$155,000 Pay Transparency TScan Therapeutics’ pay ranges are established based on external market data from third-party compensation surveys and our internal benchmarking. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Individual compensation within this range is commensurate with a candidate’s specific qualifications, including education, overall experience, relevant experience, and specific skills. We strive to ensure that compensation is competitive, equitable, and aligned with the value each TScanner brings to the role. Recruitment & Staffing Agencies TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.

Job DescriptionDescription: ADA Forsyth Institute, a globally recognized dental research institution with more than a century of scientific leadership and innovation, seeks an experienced journalist, writer, or editor to assist in the development of a book documenting the Institute's history and its evolution as a pioneer in dental and oral health research. The project has archival materials, research data, and interviews. There is a draft manuscript for much of the text. The selected consultant will help synthesize, organize, write, and edit these materials into a compelling and cohesive narrative suitable for publication. The consultant will collaborate with Institute leadership, Communications, and Senior Investigator to ensure the manuscript accurately reflects Forsyth's history, scientific contributions, and lasting impact on the field. Preferred Qualifications • Experience researching, writing, and editing books., • Strong journalism, nonfiction writing, or editorial background., • Experience covering healthcare, science, medicine, public health, or related topics., • Knowledge of the history of science, medicine, or research institutions is preferred., • Excellent research, interviewing, writing, and communication skills. Compensation This is a project-based consulting engagement. Compensation will be negotiated based on experience and qualifications and will be structured around agreed-upon project milestones and deliverables. To Apply Interested candidates should submit: • A brief statement describing their interest in and qualifications for the project;, • A résumé or CV; and, • Links to published articles, books, writing samples, or other relevant work. ADA Forsyth Institute is an equal opportunity employer, and all qualified applicants will receive consideration for this opportunity without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions or any other characteristic protected by law. Requirements:

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES The Manager, Medical Writing position is responsible for overseeing and participating in the development of high-quality clinical and regulatory documents in support of global drug development programs of PROMETRIKA’s sponsors. This role requires writing and editing of protocols and scientific and clinical reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Manager, Medical Writing will also contribute to departmental leadership, training initiatives, business development efforts and organizational thought leadership: Medical Writing • Manage and supervise junior medical writers and/or external contractors, • Oversee and/or participate in the development/writing of:, • Clinical Development Plans (CDPs), • Clinical study protocols and Clinical Study Reports (CSRs), • Coordinating and integrating writing of other document sections provided by the project statistician, medical monitor, and other team members, • Clinical sections of INDs, NDAs/BLAs and MAAs and other submission documents (e.g., ISS/ISE, Clinical Summaries), • Initial and or updates for Investigator Brochures (IBs) and IMPDs, • Annual reports and DSURs, • Briefing documents for regulatory submissions, • Journal articles, abstracts, and posters in cooperation with statisticical leads, • Ensure documents meet company, client, and regulatory standards, including ICH/GCP guidelines, • Oversee multiple projects simultaneously, ensuring timelines and deliverables are met, • Conduct document review meetings to discuss comments/ edits by PROMETRIKA Team and/ or Sponsor, • Provide cross-functional medical writing support, • Attend client meetings as required, • Assist with tracking and reporting significant changes in scope of work and recommending change of scope orders to management, when appropriate, • Perform other duties as assigned Departmental responsibilities • Develop and update on an ongoing basis medical writing SOPs and training manuals, • Develop and lead Medical Writing departmental initiatives aligned with organizational strategic goals, • Uphold, demonstrate and teach junior team members PROMETRIKA’s Core Competencies, • Develop internal training materials and deliver trainings as in support of PROMETRIKA Technical Training Committee initiatives, • Recruit, develop, mentor and supervise team members as appropriate to meet the service obligations of the department Thought Leadership • Contribute materials and present at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization, • Proactively contribute to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate Business Development Support • Collaborate with Client Relations to participate in Medical Writing at bid defense meetings, • Partner with Client Relations on efficient and timely completion of Requests for Information (RFIs) and Requests for Proposals (RFPs) EDUCATION • Bachelor’s Degree in Science is required, • MS or a Ph.D. is preferred EXPERIENCE • A minimum of 10 years experience in biotechnology/pharmaceutical industry, • A minimum of 7 years regulatory writing in biotechnology/ pharmaceutical industry, • Experience managing medical writers or contractors preferred, • Previous experience in developing clinical and regulatory documents, such as protocols, CSRs, IBs, INDs, ISS/ISE, and DSURs. Previous involvement in writing at least one NDA/BLA/ MAA is required, • Previous experience working in a clincial research organization (CRO) is strongly preferred SKILLS • Knowledge of ICH /GCP, FDA, EMA and other regulatory guidance for clinical and regulatory submissions, • Strong command of scientific and medical terminology with the ability to translate complex information into clear, accurate, and regulatory-compliant content, • Excellent written and verbal communication skills, with attention to detail and quality, • Ability to manage multiple projects and competing priorities in a fast-paced environment, • Knowledge of electronic document platforms is desired, • Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job Description Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X. We are seeking a CTA/Senior CTA who will work with the Clinical Study Lead and Director of Clinical Operations to support the conduct of clinical trials. You will partner with the Clinical Study Lead to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. You may independently manage components of clinical studies, including but not limited to vendor oversight, budgets, responsibility for a subset of sites or countries, or phases of the trial (startup period, for example), with oversight. Responsibilities • Support the Clinical Study Lead and Clinical Operations team in the day-to-day operational activities of clinical trials to ensure study objectives, timelines, quality standards, and regulatory requirements are met., • Support oversight of CROs, vendors, and investigator sites, including review of monitoring visit reports, site communications, and follow-up on study-related actions and issues., • Maintain study tracking tools for key study documentation (e.g., Form FDA 1572) and operational activities, including site activation, enrollment, monitoring visit status, IRB/EC approvals, safety letter distribution, training compliance, and study milestones., • Support Trial Master File (eTMF) activities, including document collection, filing, reconciliation, quality control reviews, and inspection readiness efforts., • Support preparation of study agendas, meeting minutes, action item logs, and study status reports while ensuring effective communication across internal teams, CROs, vendors, and investigator sites., • Collaborate cross-functionally with Regulatory Affairs, Clinical Supplies, Data Management, Safety, Quality, and other functional areas to support study deliverables and timelines., • Manage study team training records and ensure compliance with applicable SOPs, regulations, study requirements, and company policies., • Manage system access requests for study team and site personnel, as needed., • Communicate and escalate study risks, protocol deviations, operational challenges, and other study-related issues as appropriate.Education & Experience, • Bachelor’s degree in scientific or related field with 2+ years of experience in Clinical Operations, clinical research or healthcare, or equivalent experience, • Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential, • Demonstrated efficiency in partnering with CROs and vendors, • Computer proficiency (Word, Excel, PowerPoint, Project), • Works proactively and efficiently in a fast-paced, high change environment, • Must have excellent interpersonal, written and verbal communication skills, • Ability to interact well with various team members and provide value added support to project, • Outstanding organization skills, • Strong analytical, strategic thinking, and problem-solving skills., • Ability to quickly learn new tools, systems, and processes to improve efficiencyWhat We Offer, • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment, • Competitive compensation, including base salary, performance bonus, and equity, • 100% employer-paid benefits package, • Flexible PTO, • Two, one-week company-wide shutdowns each year, • A commitment to your professional development, with access to resources, mentorship, and growth opportunitiesSalary RangeThe anticipated salary range for this position is $108,000 to $132,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Additional Description for Pay Transparency:The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits Please note: Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes. #LI-CBIO

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES The Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, study protocol, company goals, and budgets. The CTM will have the following responsibilities as assigned: • Manage the operational aspects of clinical trials (e.g., study management, site monitoring and management, trial master file (TMF) oversight,), • Coordinate and support regulatory submissions and notifications (e.g., IND/CTA amendments, annual reports), as applicable, • Support the management of the ongoing study budget tracking, forecasting, and reconciliation, for Clinical Operations services, • Assist in Development of and manage the study project plan, including timeline, budget, and resources, • Participate in protocol, CRF and strategy development, Clinical Study Report (CSR) preparation, NDA submission, as appropriate, • Prepare metrics and updates for management, as assigned, • Proactively identify potential study issues/risks and recommend/implement solutions, • Prepare and/or review/approve study-related documents (e.g., Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Study Operational Guildelines, Pharmacy Manual, Integrate Quality Risk Management Plan and CRF Completion Guidelines), • Participate in quality risk assessments and develop Key Performance Indicators (KPIs); including identification of quality issues within the study to implement appropriate corrective action plan, • Participate in and facilitate vendor selection process for outsourced activities, • Review and approve vendor invoices and assess financial impact of scope changes, • Provide ongoing oversight of clinical vendor service providers, including performance monitoring, KPI review, issue escalation and corrective active implementation, • Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations, • Ensure inspection readiness for assigned studies, support regulatory authority inspections, internal audits and responses to audit findings in collaboration with Quality Assurance and Regulatory Affairs, • Manage Clinical Trial Associates (CTA) and other study staff, as needed, • Recommend and implement innovative process ideas to impact clinical trials management, • Organize and manage internal team meetings, investigator meetings and other trial-specific meetings, • Collaborate with Pharmacovigilance and Medical Monitoring to ensure timely safety reporting, SAE reconciliation, and operational alignment with safety processes and vendors, • Partner with Data Management and Biostatistics to oversee clinical data quality metrics, support data cleaning activities, and ensure study readiness for database lock, • Develop site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments, • Manage the feasibility, selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function, • Review and identify trends in enrollment and data entry at sites, and identify solutions, • Manage drug supply and non-drug supply needs of the study, • Develop and implement departmental Standard Operating Procedures, as necessary, • Contribute to knowledge sharing and training opportunities within the department and the company, • Contribute to PROMETRIKA Thought Leadership and marketing campaigns (as necessary), • Mentor and trial junior team members and cross-functional team members (as necessary), • Represent Clinical Operations at bid defense and capabilities presentations, • Perform other duties as required EDUCATION • Bachelor’s degree in life sciences, nursing, pharmacy, public health or related field is required, • Master’s degree (e.g., MS, MPH, MBA) or advanced scientific/clinical training is highly valued but not required, • Project Management Professional (PMP)certification is highly valued but not required EXPERIENCE • Minimum of 5 years working in the clinical research/biotech industry with progressive responsibility in clinical trial operations, • Demonstrated experience managing multiple studies, sites and vendors, included blinded study experience, • Hands-on experience with all phase of the project lifecycle include study start-up, maintenance and close-out, • Hands-on experience study and site management, site monitoring oversight, clinical vendor management, clinical trial risk management, TMF management, and regulatory submissions (e.g., CSR, NDA support)., • Experience working in cross-functional teams and direct involvement in protocol and CRF development is highly valued, • Proven track record of ensuring GCP/regulatory/protocol compliance, managing timelines and budgets, leading risk assessments, and implementing CAPAs and KPIs SKILLS • Working knowledge of the clinical drug development process, • Strong knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, • Strong analytical and problem-solving skills, • Written, verbal communication and presentation skills in small and large group settings, • Must possess excellent interpersonal skills, • Mentoring/coaching, • Ability to effectively multi-task and prioritize, • Organizational skills and attention to detail required, • Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint, • Cross functional and cross-cultural awareness, • Ability to work in a matrix environment. Must have the ability to build and maintain positive relationships with management, peers, and direct reports, • Ability to deal with time demands, incomplete information or unexpected events Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job DescriptionDescriptionOPENING DATE: May 20, 2026 CLOSING DATE: June 19, 2026 SERIES/GRADE: 0855/14 TYPE OF POSITION: Trust Indefinite (Non-Federal) DIVISION: Central Engineering LOCATION: Cambridge, MAAREA OF CONSIDERATION: This position is open to all qualified candidates eligible to work in the United States. This position requires access to export-controlled work. The candidate must be a U.S. person (citizen, permanent resident, or national of a country eligible for approval under an export license). What are Trust Fund Positions?Trust Fund positions are unique to the Smithsonian. They are paid for from a variety of sources, including the Smithsonian endowment, revenue from our business activities, donations, grants and contracts. Trust employees are not part of the civil service, nor does trust fund employment lead to Federal status. The salary ranges for trust positions are generally the same as for federal positions and in many cases trust and federal employees work side by side. Trust employees have their own benefit program, which may include Health, Dental & Vision Insurance, Life Insurance, Transit/Commuter Benefits, Accidental Death and Dismemberment Insurance, Annual and Sick Leave, Family Friendly Leave, 403b Retirement Plan, Discounts for Smithsonian Memberships, Museum Stores and Restaurants, Credit Union, Flexible Spending Account (Health & Dependent Care). Conditions of Employment • Pass Pre-employment Background Check and Subsequent Background Investigation, as required., • Complete a Probationary Period if applicable., • Maintain a Bank Account for Direct Deposit/Electronic Transfer., • The position is open to all candidates eligible to work in the United States. Proof of eligibility to work in U.S. is not required to apply., • Applicants must meet all qualification and eligibility requirements within 30 days of the closing date of this announcement. OVERVIEWINTRODUCTION The Smithsonian Astrophysical Observatory (SAO) is at the forefront, internationally, of the scientific exploration of the universe. SAO combines its resources with those of the Harvard College Observatory to form the Harvard-Smithsonian Center for Astrophysics (CfA). The CfA is the best-known astrophysics center in the world. Its programs range from ground-based astronomy and astrophysics research to space-based research, the engineering and development of major scientific instrumentation for space launch and use in large ground-based facilities, and research designed to improve science education. The research objectives of SAO are carried out primarily with the support of Government and Smithsonian Institution funds, with additional philanthropic support. Government funds are in the form of Federal appropriations or the form of contracts and grants from other agencies. In contrast, Institution funds are available to SAO through grants from the Institution's Restricted Funds, Special Purpose Funds, Bureau Activities, Business Activities, and non-Federal contracts and grants. SUMMARY The purpose of the position is to provide expert level electronics and electrical systems engineering support in the development of advanced instrumentation for ground-based and space-based astrophysical and astronomical data collection on various Central Engineering supported projects. MAJOR DUTIES 1. Applies broad knowledge of state-of-the-art to conceive, plan, and execute complex and varied assignments in the electrical engineering required to develop cutting edge instrumentation for astrophysical and astronomical data collection; as well as for its associated test, calibration, and other ground support equipment. a. Conceives, designs, and oversees development of complex state-of-the-art electrical/electronics systems, subsystems, modules, and components. Provides expert technical consultation to CfA scientists and other engineering staff in instrument electrical design. b. Translates scientific objectives into achievable hardware that exploits or extends state-of-the art, advances current technology, and works with scientific investigators to establish the electrical/electronics requirements of new projects. Analyzes scientific data collection requirements, translates these requirements into instrument performance characteristics, and develops instrument concepts and preliminary systems diagrams. c. Performs critical trade-off analyses of various design implementations. Makes and documents recommendations for optimum methods considering both known and anticipated operating environments. d. Evaluates manufacturers’ performance capability data for discrete, hybrid, and integrated circuitry, components, and systems. Incorporates analysis results into design decisions. e. Prepares cost and schedule estimates for hardware design, fabrication, test, and calibration; including supporting documentation. f. Extensively documents work in technical memoranda, reports, test plans, procedures and presentations.2. Defends proposals to funding agency and/or scientific peer review panels in support of the Principal Investigator. Troubleshoots and analyzes complex technical problems encountered on CE projects, identifies and recommends solutions, and oversees their implementation.3. From conceptual design through project completion, provides leadership in design and analysis and documentation. Maintains a technical overview of the project in process, and has ultimate responsibility for the design and test integrity of the contract or project end item. Chooses appropriate technologies, establishes technical priorities, and performs conceptual, systems level, and detail design. Prepares cost estimates, schedules, plans, technical reports, and engineering input to project proposals; supervises engineers, designers, and technicians assigned to the project; and maintains engineering budgets and schedules. Provides technical leadership and direction to, and liaison with, hardware contractors and sub-contractors as required.4. Investigates, selects, justifies, and oversees procurement of critical electrical, electro-optical, and servo-mechanical components used in astrophysical instrumentation and its development. 5. Makes both oral and written presentations to project scientists and technical representatives of contracting agencies and cooperating or affiliated organizations: Either singly or in collaboration with project scientists and other engineers, may write technical papers recording innovative design techniques and criteria, and present papers to technical symposia in the specialty field.6. Travels, both domestically and internationally, to telescope sites, vendor facilities, NASA centers, and the facilities of other associated organizations in support of proposal, design, calibration, test, integration, and mission operations activities.7. Performs other assignments as required. QUALIFICATION REQUIREMENTSBasic Requirements: Degree: Professional Engineering. To be acceptable, the curriculum must: (1) be in a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum; or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics; (d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties); and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics. OR a combination of education and experience--college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying professional engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering. OR Bachelor's degree in computer science or bachelor's degree with 30 semester hours in a combination of mathematics, statistics, and computer science. At least 15 of the 30 semester hours must have included any combination of statistics and mathematics that included differential and integral calculus. All academic degrees and course work must be from accredited or pre-accredited institutions. Additional Requirements: Candidates must possess at least one year of specialized experience at or above the grade 13 level in similar positions. Specialized experience for this position would include architecting system-level electrical designs using both commercial and custom electronics, leading the electrical engineering effort, supporting project design reviews, and participating in reviews of other projects. Knowledge, Skills, and Abilities required: • Mastery of advanced concepts, principles and practices of electronics engineering, in order to investigate, design, and provide consultative services to the development of an entire range of electronics for ground based and space-borne instrumentation for astrophysical data collection, as well as its associated test, calibration and ground support equipment. This will be evidenced by significant professional experience in overall systems design including electrical systems design and analysis, system resource and error budgeting, documentation, proposal preparation, sophisticated computer modeling and fabrication and test activities pertaining to the development of state-of-the-art scientific instrumentation., • Ability to apply advanced principles and practices of electronics engineering to the development and application of experimental theories, and emerging technology to the solution of complex instrument design problems., • Extensive experience with electrical schematic and board layout CAD/CAM tools., • Expert knowledge of analog design techniques and design simulation tools (i.e. SPICE)., • Experience with the development of FPGA based digital and analog signal processing systems., • Working knowledge of related engineering fields such as thermal, mechanical, optical and/or structural in order to resolve design and instrument packaging problems., • Skill in project leadership and the ability to provide technical direction in design, fabrication, assembly, and test activities to members of a diverse engineering and scientific team. Ability to generate realistic project budgets and schedules and support multiple projects simultaneously., • Strong oral and written communications skills, including the ability to serve as a technical spokesperson for SAO in areas related to the electronics of advanced instrumentation. Experience with proposal writing.Education completed outside the United States must be deemed equivalent to higher education programs of U.S. Institutions by an organization that specializes in the interpretation of foreign educational credentials. This documentation is the responsibility of the applicant and should be included as part of your application package. Any false statement in your application may result in rejection of your application and may also result in termination after employment begins. Join us in "Inspiring Generations through Knowledge and Discovery." Resumes should include a description of your paid and non-paid work experience that is related to this job; starting and ending dates of job (month and year); and average number of hours worked per week. What To Expect Next: Once the vacancy announcement closes, a review of your resume will be compared against the qualification and experience requirements related to this job. After review of applicant resumes is complete, qualified candidates will be referred to the hiring manager. Relocation expenses are not paid. The Smithsonian Institution provides reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation should contact hr@cfa.harvard.edu. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. To learn more, please review the Smithsonian’s Accommodation Procedures. The Smithsonian Institution is an Equal Opportunity Employer. We believe that a workforce comprising a variety of educational, cultural, and experiential backgrounds support and enhance our daily work life and contribute to the richness of our exhibitions and programs. See Smithsonian EEO program information: https://www.si.edu/oeesd. The Smithsonian Astrophysical Observatory is an equal opportunity employer. Please visit the SAO website at http://www.cfa.harvard.edu/

Job DescriptionHealthcare Fraud Investigator Employment Type: Full-Time, Mid-Level Department: Litigation Support CGS is seeking a Healthcare Fraud Investigator to provide Legal Support for a large Government Project in Nashville, TN. The candidate must take the initiative to ask questions to successfully complete tasks, perform detailed work consistently, accurately, and under pressure, and be enthusiastic about learning and applying knowledge to provide excellent litigation support to the client. CGS brings motivated, highly skilled, and creative people together to solve the government’s most dynamic problems with cutting-edge technology. To carry out our mission, we are seeking candidates who are excited to contribute to government innovation, appreciate collaboration, and can anticipate the needs of others. Here at CGS, we offer an environment in which our employees feel supported, and we encourage professional growth through various learning opportunities. Responsibilities will Include:- Review, sort, and analyze data using computer software programs such as Microsoft Excel.- Review financial records, complex legal and regulatory documents and summarize contents, and conduct research as needed. Preparing spreadsheets of financial transactions (e.g., check spreads, etc.).- Develop HCF case referrals including, but not limited to:- Ensure that HCF referrals meet agency and USAO standards for litigation.- Analyze data for evidence of fraud, waste and abuse.- Review and evaluate referrals to determine the need for additional information and evidence, and plan comprehensive approach to obtain this information and evidence.- Advise the HCF attorney(s) regarding the merits and weaknesses of HCF referrals based upon applicable law, evidence of liability and damages, and potential defenses, and recommend for or against commencement of judicial proceedings.- Assist the USAO develop new referrals by ensuring a good working relationship with client agencies and the public, and by assisting in HCF training for federal, state and local agencies, preparing informational literature, etc. - Assist conducting witness interviews and preparing written summaries. Qualifications:- Four (4) year undergraduate degree or higher in criminal justice, finance, project management, or other related field.- Minimum three (3) years of professional work experience in healthcare, fraud, or other related investigative field of work.- Proficiency in Microsoft Office applications including Outlook, Word, Excel, PowerPoint, etc.- Proficiency in analyzing data that would assist in providing specific case support to the Government in civil HCF matters (E.g., Medicare data, Medicaid data, outlier data).- Communication skills: Ability to interact professionally and effectively with all levels of staff including AUSAs, support staff, client agencies, debtors, debtor attorneys and their staff, court personnel, business executives, witnesses, and the public. Communication requires tact and diplomacy.- U.S. Citizenship and ability to obtain adjudication for the requisite background investigation.- Experience and expertise in performing the requisite services in Section 3.- Must be a US Citizen.- Must be able to obtain a favorably adjudicated Public Trust Clearance.Preferred qualifications:- Relevant Healthcare Fraud experience including compliance, auditing duties, and other duties in Section 3.- Relevant experience working with a federal or state legal or law enforcement entity. #CJ We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionCrescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X. We are seeking a Medical Lead to provide clinical leadership for one or more programs from preclinical through clinical development. You will own the medical strategy, lead study design and execution, and serve as the clinical face of the program with investigators, partners, and internal teams. This is a hands-on role suited for someone who thrives in a dynamic startup environment.Responsibilities • Develop and implement the clinical development strategy and target product profile for assigned program(s)., • Lead the design, initiation, and execution of early-phase clinical studies, including protocol and investigator brochure development, endpoint selection, and dose-escalation strategies., • Serve as the medical monitor of ongoing studies, ensuring subject safety, high-quality data collection, and adherence to GCP and regulatory standards., • Interpret and communicate emerging data across internal and external stakeholders, contributing to clinical study reports, publications, and presentations., • Contribute clinical content for regulatory submissions, including IND/CTA filings, amendments, and briefing documents; support interactions with health authorities., • Partner closely with cross-functional colleagues in nonclinical, translational, clinical operations, regulatory, program management and CMC to align program objectives and milestones., • Build and maintain relationships with key opinion leaders, clinical investigators, and partners to inform study design and program direction.Education & Experience, • MD (or equivalent) with clinical training in oncology, immuno-oncology, or a related medical specialty., • Minimum of 7 years of experience in the life sciences industry, including substantial oncology-focused medical oversight responsibilities., • Hands-on experience in biotech environment with antibody–drug conjugates (ADCs) or other targeted biologic therapies and preferred., • Demonstrated experience in clinical drug development, with deep understanding of trial design, execution, and data interpretation in biotech or biopharma settings., • Proven track record authoring clinical trial documents (protocols, IBs, CSRs) and contributing to regulatory submissions (IND, CTA, amendments, briefing books)., • Strong knowledge of regulatory agency guidelines (FDA, EMA, ICH-GCP) and experience supporting GCP audits or regulatory inspections related to clinical trial conduct., • Exceptional analytical and communication skills, with the ability to synthesize complex data into clear, actionable insights., • Recognized for strong leadership, cross-functional collaboration, and relationship-building skills with both internal and external stakeholders., • Self-motivated, detail-oriented, and adaptable, with a proactive approach to problem-solving and execution in a fast-paced environment.What We Offer, • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment., • Competitive compensation, including base salary, performance bonus, and equity., • 100% employer-paid benefits package., • Flexible PTO., • Two, one-week company-wide shutdowns each year., • A commitment to your professional development, with access to resources, mentorship, and growth opportunities. Additional Description for Pay Transparency:The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits #LI-CBIO

The Senior Medical Director for Pipeline is a highly visible and business‑critical role that is part of the Medical Strategy team within Alkermes Medical Affairs. This role leads medical affairs efforts related to our early‑and mid‑stage development compounds. The Senior Medical Director for Pipeline will need to understand the business strategies and drivers underlying our emerging assets and translating those drivers into strategies and data generation and communication plans. The incumbent will need to effectively collaborate and communicate with colleagues within Medical Affairs, key cross‑functional partners (e.g., New Product Planning, Clinical Development), and frequently represent the function and the company to senior management as well as with leading healthcare professionals. • Contribute to the identification of therapeutic areas to pursue with our pipeline agents based on mechanism of action, pathophysiology, unmet need, and other considerations, • Contribute strategic input into the design and selection of endpoints to be included in clinical trials, • Develop and maintain an in‑depth awareness of the evolving treatment landscape, therapeutic area trends, pharmaceutical/biotech company pipelines, and the evolving payer landscape and communication needs across disease areas of focus for Alkermes' pipeline assets, • Analyze and interpret scientific data, disease/treatment landscape, and external stakeholder evidence to identify challenges, opportunities, and strategic imperatives to communicate and demonstrate our portfolio value, • Foster relationships with and solicit input from key medical opinion leaders, researchers, and relevant medical societies and patient advocacy organizations, • Collaborate with Health Outcomes Research and Patient Advocacy to represent the patient voice in our clinical development activities, • Provide medical and scientific training and/or support to other staff across functions, • Lead the medical affairs strategic planning process for our pipeline assets and ensure strategic alignment of medical plans to Alkermes' programmatic goals and objectives. Ensure execution of medical tactics associated with the strategic plan(s), • Guide the scientific and medical communication planning process. Review and approve scientific publications, investigator‑initiated study proposals, medical education grant initiatives, corporate communications and others, • Highly motivated self‑starter who can work independently, manage complex issues, and relate to multiple internal and external stakeholders, • Experience working in a highly matrixed team environment and a demonstrated ability to lead through influence across the organization and at all vertical levels, • Proven record of problem solving, excellent communication skills (written and verbal), and experience interacting with and presenting to senior management and key external stakeholders, • Advanced degree in science or medicine required (e.g., MD, PhD, PharmD), • Strong track record within the biopharmaceutical industry, with a minimum of 5 years' experience, • Experience in Medical Affairs preferred, • Specialized training or experience in neurology or psychiatry preferred, • Experience with peer‑reviewed publications, • Strong scientific background, creativity, flexibility, • Working knowledge of regulatory and compliance requirements, • Willingness/ability to travel up to 25%, with both domestic and international travel expected, • This role is preferred Hybrid (3 days per week in office) Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. The annual base salary for this position ranges from $285,000 to $305,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer. #J-18808-Ljbffr

The Senior Medical Director for Pipeline is a highly visible, business‑critical role within the Medical Strategy team of Alkermes Medical Affairs. The role leads medical affairs efforts related to early and mid‑stage development compounds, translating business strategies and emerging asset drivers into data generation, communication plans, and cross‑functional collaborations. The incumbent collaborates with colleagues across Medical Affairs, New Product Planning, Clinical Development, and represents the function to senior management and key healthcare professionals. • Contribute to the identification of therapeutic areas to pursue with our pipeline agents based on mechanism of action, pathophysiology, unmet need, and other considerations, • Contribute strategic input into the design and selection of endpoints to be included in clinical trials, • Develop and maintain an in‑depth awareness of the evolving treatment landscape, therapeutic area trends, pharmaceutical/biotech company pipelines, and the evolving payer landscape and communication needs across disease areas of focus for Alkermes’ pipeline assets, • Analyze and interpret scientific data, disease/treatment landscape, and external stakeholder evidence to identify challenges, opportunities, and strategic imperatives to communicate and demonstrate our portfolio value, • Foster relationships with and solicit input from key medical opinion leaders, researchers, and relevant medical societies and patient advocacy organizations, • Collaborate with Health Outcomes Research and Patient Advocacy to represent the patient voice in our clinical development activities, • Provide medical and scientific training and/or support to other staff across functions, • Lead the medical affairs strategic planning process for our pipeline assets and ensure strategic alignment of medical plans to Alkermes’ programmatic goals and objectives, ensuring execution of medical tactics associated with the strategic plan(s), • Guide the scientific and medical communication planning process. Review and approve scientific publications, investigator‑initiated study proposals, medical education grant initiatives, corporate communications and others, • Highly motivated self‑starter who can work independently, manage complex issues, and relate to multiple internal and external stakeholders, • Experience working in a highly matrixed team environment and a demonstrated ability to lead through influence across the organization and at all vertical levels, • Proven record of problem solving, excellent communication skills (written and verbal), and experience interacting with and presenting to senior management and key external stakeholders, • Advanced degree in science or medicine required (e.g., MD, PhD, PharmD), • Strong track record within the biopharmaceutical industry, with a minimum of 5 years’ experience, • Experience in Medical Affairs preferred, • Specialized training or experience in neurology or psychiatry preferred, • Experience with peer‑reviewed publications, • Strong scientific background, creativity, flexibility, • Working knowledge of regulatory and compliance requirements, • Willingness/ability to travel up to 25%, with both domestic and international travel expected, • This role is preferred Hybrid (3 days per week in office), • The annual base salary for this position ranges from $285,000 to $305,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. #J-18808-Ljbffr

Director, Medical Affairs, Rare DiseaseApplylocations: Cambridge (US)time type: Full timeposted on: Posted Todayjob requisition id: R-21734Title:Director, Medical Affairs, Rare DiseaseCompany:Ipsen Biopharmaceuticals Inc.About Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at https://www.ipsen.com/and follow our latest news on LinkedIn and Instagram.Job Description:WHAT - Summary & Purpose of the PositionThe Director, Medical Affairs, is responsible for leading and overseeing key Medical Affairs activities in alignment with the US and Global Rare Disease strategy for Pediatric Cholestatic Rare Disease. This role serves as a primary medical and scientific leader for the therapeutic area, providing guidance to internal and external stakeholders and ensuring alignment across cross functional teams.The Director leads the development and execution of the US Medical Affairs strategy and overall medical plan for pediatric cholestatic diseases. Key responsibilities include leading Medical Strategic Team activities, advisory board planning and execution, and cross functional collaboration to ensure integration of medical strategies. The role also includes oversight of medical information responses (in collaboration with Medical Information), scientific communications (including publications and congress presentations in partnership with the Publication team), and the design and medical oversight of US based clinical studies, as well as the review and approval of promotional and medical materials and educational grants.The Director works closely with the Medical Science Liaison team to guide field medical strategy, develop and maintain relationships with key opinion leaders, and incorporate field insights into medical planning. Additional responsibilities include assessing investigator sponsored study requests, supporting internal and external training through knowledge transfer, and ensuring accurate, timely responses to medical information requests.Key internal partners include US and Global Medical Affairs, Clinical Operations, the Rare Disease commercial team, and global Rare Disease franchise medical personnel.WHAT - Main Responsibilities & Technical Competencies* Through Medical Affairs Information and the MSL team, ensure the development and dissemination of medically sound information to support the safe and effective use of Bylvay in accordance with Ipsen and regulatory guidelines.* Contribute to the planning and budget oversight of medical activities for pediatric cholestatic diseases. Develop and maintain relationships with key opinion leaders and external stakeholders to gather insights and inform medical strategy. Serve as the medical and scientific representative on disease area and asset cross functional teams, ensuring alignment across stakeholders. Provide medical and scientific leadership to cross functional teams, integrating insights to inform strategy and execution. Lead, when appropriate, content development and presentation for external medical education programs Lead the planning and execution of advisory boards (national and regional). Ensure appropriate scientific, disease, and Ipsen product training for the MSL team and other internal partners, in collaboration with Knowledge Transfer. Review and approve promotional and medical materials (PRC and MRC, as applicable). Identify needs and provide directions on the development of proactive and reactive field medical materials (e.g., FAQs, medical objection handlers, advisory board content) in collaboration with field teams. Contribute to the US scientific publication strategy planning and oversee clinical study design and execution in collaboration with Medical Affairs Operations. Oversee the development and execution of the Rare Disease KOL identification strategy and process. Lead medical congress strategy and execution, including scientific exchange and congress coverage. Lead Medical Strategic Team activities, ensuring alignment with US and Global Rare Disease medical strategy. Oversee clinical grants and medical education funding activities, including providing medical input and budget management in collaboration with the Grants Manager. Manage travel and expense budget in line with Ipsen guidelines.* Ensure compliance with all applicable laws, regulations, and Ipsen policies.HOW - Knowledge & ExperienceKnowledge & Experience (essential): 8+ years of experience in the pharmaceutical industry, including 5–8 years in Medical Affairs strategy Significant experience in Rare Disease required; experience in Liver or Gastroenterology is an asset. Knowledge of clinical trial design, biostatistics. Experience in presenting and publishing scientific information. Ability to work across multiple functions & cultures & embrace team diversity. Enterprise and strategic with ability to identify & create solutions to various scenarios. Strong verbal & written communication skills, presentation, & coaching skills. Excellent interpersonal skills & problem-solving capabilities. Experience with organizational skills & business planning. Proven project management, tracking & reporting of outcomes. Strong organizational skills & ability to deal with competing priorities. Strong reasoning & creative solving skills. Strong knowledge of US PhRMA, OIG, FDA rules & regulations & guidelines relating to compliant medical engagements Proven ability to work in & embrace a fast-paced & dynamic work environment with a high level of autonomy. Ability to travel up to 40% of the time i.e., Attend HCP/customer meetings; attend scientifical/medical conferences, attend Cambridge, MA meetings, etc.)Knowledge & Experience (preferred): Clinical trials/research experience is a plus.Education / Certifications (essential): Advanced degree in a scientific discipline (MD, PhD, or PharmD) required.Language(s) (essential): Fluent in English.Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.All Employees are expected to adhere to all company policies and act as a role model for company values.The annual base salary range for this position is $225,000-$300,000.This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr

Senior Medical Director, Alixorexton, is a highly visible and business-critical role that is part of the Medical Strategy team within Alkermes Medical Affairs. This role leads medical affairs efforts for Alixorexton within our sleep medicine program, including oversight of medical activities to drive a successful product launch. Alixorexton is a novel orexin 2 receptor agonist being developed for the treatment of disorders of hypersomnolence and is our lead compound for our orexin biology platform. The incumbent will need to understand the business strategies and drivers underlying our Alixorexton program, translating those drivers into strategies and data generation and communication plans that contribute to a successful product launch, and ensure alignment of Alixorexton activities across our neuroscience portfolio. A successful candidate will demonstrate their ability to effectively collaborate and communicate with colleagues within Medical Affairs, with key cross‑functional partners (e.g., Commercial, Clinical Development, Biostatistics), and frequently represent the function and the company to senior management as well as healthcare professionals. • Serve as a subject matter expert in sleep medicine, orexin biology, and Alixorexton data. Maintain an organizational awareness of the evolving sleep medicine treatment landscape, relevant pharmaceutical/biotech company pipelines, and evolving payer trends and needs., • Analyze and interpret scientific data, disease/treatment landscape, and external stakeholder evidence to identify challenges, opportunities, and strategic imperatives to communicate and demonstrate the value of Alixorexton., • Lead the medical affairs strategic planning and launch planning processes for Alixorexton and ensure alignment of the medical plans to Alkermes’ programmatic goals and objectives. Ensure execution of medical tactics associated with our strategic plans., • Lead the Alixorexton Medical Affairs Strategy Team and participate in key cross‑functional program teams, including launch planning., • Contribute to the scientific and medical communication planning process. Review and approve scientific publications, investigator‑initiated study proposals, medical education grant initiatives, corporate communications and others., • Help design our areas of interest for independent investigator research proposals and collaborate with our Lifecycle Management team and Regulatory on the strategic direction and design of phase 3b and 4 studies that build the Alixorexton data package and lay the groundwork to future label updates., • Collaborate with other sleep medicine medical directors to establish medical education areas of focus and review CME grant applications., • Foster relationships with and solicit input from key medical opinion leaders, researchers, and relevant medical societies and patient advocacy organizations., • Collaborate with Health Outcomes Research and Patient Advocacy to represent the patient voice in our clinical development activities., • Provide medical and scientific training and/or support to other staff internally across functions as needed., • Represent the Alixorexton medical team in front of senior leaders., • Highly motivated self‑starter who can work independently, manage complex issues, and relate to multiple internal and external stakeholders., • Experience working in a highly matrixed team environment and a demonstrated ability to lead through influence across the organization and at all vertical levels., • Proven record of problem solving, excellent communication skills (written and verbal), and experience interacting with and presenting to senior management and key external stakeholders., • Doctorate in Medicine (MD) required. Prior experience or specialized training in sleep medicine or neuroscience considered a plus., • Strong track record within the biopharmaceutical industry, with a minimum of 5 years’ experience. Experience in Medical Affairs preferred., • Experience with peer‑reviewed publications., • Strong scientific background, creativity, flexibility., • Working knowledge of regulatory and compliance requirements., • Willingness/ability to travel up to 25%, with both domestic and international travel expected., • This role is Hybrid (3 days per week in the Waltham, MA office). Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees, and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. The annual base salary for this position ranges from $285,000 to $305,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer. #J-18808-Ljbffr

Your Impact Alpha-9 Oncology is seeking a highly motivated Clinical Operations Manager with a strong background in oncology clinical trials and vendor management to support the day-to-day execution of radiopharmaceutical studies. In this role, you will ensure clinical activities are conducted in alignment with protocols, applicable regulations, and company SOPs while partnering closely with the Clinical Operations Leader, who provides overall study strategy and accountability for trial delivery. This is a hands-on role for someone who enjoys solving problems, coordinating across teams and vendors, and driving progress in a fast-paced clinical environment. You will play a key role in translating study strategy into effective execution and helping advance therapies that impact patients. This role reports to the Clinical Operations Leader. How You'll Contribute Support tracking of clinical trial timelines, budgets, key operational metrics, and study risks, including site activation, enrollment progress, and monitoring issues. Support the CRO/vendor selection strategy and development of operational strategies including country & site selection. Contribute to the development of site feasibility questionnaires and analysis of the feasibility results. Manage day-to-day relationships with clinical trial vendors, including tracking vendor contracts, budgets, invoices, and payments against contracted scope of work, and escalating issues or variances to Clinical Operations leadership. Provide operational input into the development of clinical protocols, informed consent, study manuals, study reports, eCRF and other key operational/regulatory documents. Collaborate with cross-functional teams including Data Management, Clinical Sciences, and Clinical Development to support study execution and resolution of operational issues. Review study site monitoring reports in alignment with the CRO oversight plan. Responsible for maintaining internal study documents in the Trial Master File (TMF) and periodically reviewing the CRO TMF for completeness and accuracy. Support forecasting and management of clinical trial supplies (e.g., lab kits) to ensure sites have the materials needed to conduct studies. Assist in the preparation of Investigator and Study Coordinator Meetings. Ensure study adherence to regulatory requirements (ICH, FDA, EMA, etc.) and ICH/GCP guidelines and SOPs. Provide input to the drafting of governance documents, SOPs, work instructions, and other resources. The Skills You Bring Bachelor's degree in Life Sciences or a related field; advanced degree preferred, with 3-5 years of experience in clinical operations within the pharmaceutical or biotechnology industry. Working knowledge of ICH/GCP regulations. Experience with early-stage oncology trials required; radiopharmaceutical experience preferred. Strong organization skills and keen attention to detail. Excellent writing and communication skills. Proven ability to proactively identify and resolve issues and ability to work independently on operational assignments. * Willingness to roll up your sleeves and get the job done. Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization. What's In It For You: At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company. Company Summary Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting. Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy. More about Alpha-9 Oncology Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate. We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.

Department: 4000US - Medical Affairs - USLocation: Waltham, MACompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at , and follow us on X, LinkedIn and Facebook.Role Summary:The Senior Director, Epidemiology and Real World Evidence (RWE) is an enterprise expert in the application of epidemiology and real‑world evidence to support Medical Affairs–led scientific and clinical objectives. This role shapes and delivers rigorous RWE strategies that inform clinical decision‑making, advance disease and treatment understanding, and enable high‑quality scientific engagement across the portfolio.The role provides strategic leadership for interventional, observational, and epidemiologic research, including Phase 3b and Phase 4 studies as well as prevalence and incidence studies, to support endpoint development, safety and pharmacovigilance, regulatory interactions, and medical decision‑making. The Senior Director partners closely with Global Medical Directors, HEOR, Clinical Development, Biometrics, Drug Safety/Pharmacovigilance, Regulatory Affairs, Value & Access, and Commercial to generate and interpret evidence that enables asset‑level Medical Affairs strategies. This position also strengthens epidemiology and RWE capabilities across Medical Affairs and Dyne through consistent standards, governance, and scientific excellence. This role is based in Waltham, MA.Primary Responsibilities Include: Strategic Leadership, Governance & Enterprise PartnershipServes as Dyne’s scientific and methodological leader for interventional, observational, and epidemiologic research, including Phase 3b, Phase 4, and prevalence/incidence studies, to address Medical Affairs–driven evidence needs across the portfolioPartners with Medical Affairs and HEOR to develop and execute an enterprise-level epidemiology and RWE strategy aligned with organizational objectivesEstablishes governance, best practices, and standards for epidemiologic and real world research across Medical AffairsProvides expert guidance to Global Medical Directors and cross-functional teams on the appropriate use, interpretation, and limitations of real world dataActs as an internal thought leader in epidemiology, RWE, and observational research methodologiesEpidemiology, Observational & Interventional ResearchLeads the design, execution, and interpretation of epidemiologic and observational studies supporting Medical Affairs objectives, including chart reviews, post hoc analyses, prospective observational studies, investigator-initiated studies, Phase 3b/4 studies, and prevalence/incidence studiesPartners with Clinical Development and Biometrics to inform endpoint development, protocol design, and external control strategies that address key evidence needs for clinical decision-makingEnsures studies are scientifically rigorous, fit-for-purpose, compliant, and publication-readyOversees scientific dissemination through peer-reviewed publications, congress presentations, and external scientific engagementSafety, Pharmacovigilance & Regulatory SupportProvides epidemiology and RWE leadership in support of Drug Safety and Pharmacovigilance activitiesPartners with Drug Safety/Pharmacovigilance and Clinical Development to support safety surveillance, signal evaluation, and benefit–risk assessmentDesigns and oversees post-authorization safety studies (PASS), registry-based safety evaluations, observational safety studies, and long-term safety assessmentsSupports evaluation of safety signals through background incidence rate analyses, observed-to-expected analyses, and other epidemiologic approachesContributes epidemiologic expertise to risk management plans, safety specifications, and safety-related regulatory documentation, as appropriateCross-Functional Collaboration, Capability Building & Operational ExcellenceCollaborates with Global Medical Directors, HEOR, Regulatory Affairs, Value & Access, Commercial, and other partners to support asset-level integrated evidence plansEngages with health authorities in collaboration with Regulatory Affairs on epidemiology- and RWE-related interactionsBuilds and maintains relationships with external epidemiologists, academic collaborators, consortia, and patient registriesStrengthens epidemiology and RWE capabilities across Medical Affairs through training, mentorship, and knowledge sharingManages budgets, timelines, vendors, and external partners to ensure quality, compliance, and operational excellenceMonitors advances in real world data sources, analytics, and epidemiologic methods to drive innovation and continuous improvement Education and Skills Requirements: Advanced degree in epidemiology, public health, health services research, or a related discipline15+ years of relevant experience in epidemiology, real world evidence, observational research, or related scientific disciplines; or equivalent combination of education and experienceDeep expertise in epidemiologic methods, observational study design, real world data sources, and application of RWE to safety surveillance and pharmacovigilanceDemonstrated experience leading post-authorization safety studies and contributing to regulatory documentationProven ability to partner effectively across Medical Affairs, Clinical Development, Drug Safety/Pharmacovigilance, HEOR, Regulatory Affairs, and Market Access in a matrix environmentStrong track record of scientific communication, peer-reviewed publication, and external scientific engagementExperience in rare diseases and/or neuromuscular disorders strongly preferredStrong analytical, strategic, and problem-solving skills with the ability to operate as an enterprise expert and influence without authorityExceptional written, verbal, and presentation skillsWillingness to travel up to approximately 30%High level of integrity, ethics, compliance, and transparency, with flexibility to adapt to evolving scientific and organizational needsStrong alignment with Dyne’s mission, values, and commitment to patients#LI-OnsiteMA Pay Range$245,000—$300,000 USDThe pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.BACK | NEXT

Immediate need for an undercover investigator within the worldwide investigative solutions company. If you are an adventurous, adaptable, and organized professional who thrives in a fast-paced, mobile environment, we invite you to apply for this exciting role. This position offers competitive compensation, travel allowances, and hotel accommodations to support your dynamic work lifestyle. Join CoventBridge Integrity Systems as it continues its expansion into all areas of investigations, allowing continual growth for its employees. At this time, CoventBridge is not considering candidates who require visa sponsorship, currently or in the future, including but not limited to H-1B, H-2B, E-3, TN, O-1, F-1 (OPT/CPT, or J-1 Visa Statuses.) Responsibilities: Duties and responsibilities include essential functions of positions assigned to this classification. Depending on the assignment, the employee may perform a combination of some or all the following duties: • Conduct undercover investigations in all demographic areas to gather information and intelligence about the case., • Establish covert identities and maintain a low profile and confidentiality throughout investigations., • Collect physical evidence from the investigation scenes and preserve said evidence to maintain the chain of custody., • Document, photograph, catalog, and label evidence in an organized manner with efficiency between multiple online computer systems., • Maintain accurate records of all evidence transactions and prepare detailed reports documenting investigative activities., • Summarize findings, statements, and evidence collected and present findings in a clear and concise manner., • Troubleshoot and resolve computer-related issues that may arise during evidence processing., • Coordinate with state, federal, or local law enforcement agencies, legal teams, colleagues, or supervisors as needed., • Stay current with investigative techniques and technology by participating in ongoing training and professional development., • Balance a high caseload while being flexible and adapting to evolving investigative needs., • Handle unexpected situations and challenges professionally. Requirements: • Licensed or eligible to be licensed as a Private Investigator in MA and in surrounding states, • Must successfully pass a comprehensive entrance exam following the training program., • Must successfully pass a detailed background check., • Must have a willingness to be constantly on the move, traveling weekly, and staying in hotels periodically., • Must have flexibility to work varied/irregular hours and days including nights, weekends, and holidays., • Must possess strong interpersonal and communication skills to represent the company professionally in client meetings and interactions., • Must have a valid state-issued driver's license issued by the state of residency., • Must have a reliable and fuel-efficient vehicle with minimum auto liability insurance., • Must possess or be willing to purchase a laptop computer. Educational/Experience Qualifications: • Associate or Bachelor's Degree in Criminal Justice or related field, • Strong attention to detail with commitment to accuracy and quality, • Military, Law Enforcement, Quality Control/Loss Prevention background CoventBridge Integrity Systems offers the most premiere compensation and benefits package in the industry. • Competitive pay, • Paid time off, • Monthly vehicle allowance, • Company fuel card, • Company cell phone, • Medical, Dental, Vision plans, • Employer paid Life, LTD, STD insurance, • Company matching 401(k), • Travel and report writing compensation, • Company paid investigator licensing fees, • Paid ongoing career advancement training, • Timely expense reimbursement with very minimal out-of-pocket expenses The salary range for this role is $26 - $30 per hour. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. About Us: CoventBridge Integrity Systems delivers investigative services, technology, and expertise that help healthcare and government organizations protect critical programs, strengthen oversight, and address fraud, waste, abuse, and operational risk. CoventBridge Integrity Systems is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, caste, disability, veteran status, and other legally protected characteristics and maintains a drug-free workplace. CoventBridge Integrity Systems is committed to the full inclusion of all qualified individuals. As part of this commitment, CoventBridge Integrity Systems will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: Human Resources; 888-932-7364; humanresources@coventbridge.com. CoventBridge (USA) Inc. Massachusetts License # LP1389D

Boston Medical Center (BMC) is more than a hospital. Its a network of support and care that touches the lives of hundreds of thousands of people in need each year. It is the largest and busiest provider of trauma and emergency services in New England. Emphasizing community-based care, BMC is committed to providing consistently excellent and accessible health services to alland is the largest safety-net hospital in New England. The hospital is also the primary teaching affiliate of the nationally ranked Boston University School of Medicine (BUSM) and a founding partner of Boston HealthNet an integrated health care delivery systems that includes many community health centers. Join BMC today and help us achieve our Vision 2030 which is a long-term goal to make Boston the healthiest urban population in the world. Position: Public Safety Investigator Department: Public Safety Schedule: Full Time Position Summary: Under direction of the Sergeant, the Detective will perform comprehensive criminal investigations, non-criminal investigations, law enforcement and crime prevention work, conduct interview and interrogations and prepare cases for prosecution, human resources or other purposes. Responsible for enforcing BMC policy, State, local laws and ordinances. Serves as liaison to external law enforcement agencies and courts. Provides support to supervisory/managerial staff and oversees operations as assigned. Assists with program development, system enhancement and training initiatives as assigned. Ensures the medical center's core values as the basis for decision making and to facilitate the medical center's mission. Essential Responsibilities / Duties: • Works under the direction of the Public Safety Sergeant Detective or his/her designee, in coordinating investigations of incidents that occur on the properties of the Medical Center., • Conducts criminal and special investigations, including domestic violence, burglaries, thefts, robberies, assaults, internal investigations as assigned., • Responsible for the enforcement of BMC policy, City and State laws., • Prepares case documentation for filing with the District Attorney and presents case evidence in Court as required., • Coordinates with external law enforcement agencies, courts and others as needed., • Interviews and provides support to patients, visitors, employees, students and staff as needed., • May perform duties in other areas of the Police Department, when called upon to do so., • Assists other Detectives with follow-up investigations, and is actively involved in the routine gathering of evidence, questioning of witnesses, apprehension of suspects., • Provides information and guidance to the public/victims regarding case status and processes, • Coordinates and accompanies medical center staff to police agencies and the courts., • Provides consistent direction to all employees and organizes investigations to reflect responsive, customer-service focused departmental standards., • Maintains accurate and complete records on investigative assignments., • Participates in and provides training to public safety and medical center staff as directed., • Organizes activities in order to fulfill the medical center's mission statements through the creations or revision of policies and procedures, goals and objectives, quality assurance and risk management programs as requested by the Manager of Investigation., • Participates in meetings, committees, task forces, community forums and associations, etc. as requested., • Provides assistance/resources to BMC staff or departments as requested, • Assists in preparing annual operating budgets and capital budget expenses., • Recommends operations plans, including, but not limited to, the use of contracted services, scheduling methods, contingency actions, investigations, human resource functions, evaluations and labor issues., • Conforms to hospital standards of performance and conduct, including those pertaining to patient rights, so that the best possible customer service and patient care may be provided., • Utilizes Boston Medical Center's values as the basis for decision-making and to facilitate the hospital's goals & mission., • Performs other duties assigned by the Manager of Investigations. Job Requirements: Education: Associate or Bachelor's Degree preferred. Certificates, Licenses, Registrations Required: • Must possess and maintain a License to carry a firearm (LTC) in the Commonwealth of Massachusetts., • Must maintain a license to operate a motor vehicle in the Commonwealth of Massachusetts., • Must possess and maintain P.O.S.T certification and/or appointable as a Special State Police under MGL c22, s63 or meet the physical, training and background requirements to become P.O.S.T. certified. Experience: • Minimum of two years of experience in any of the following areas:, • Criminal Investigation/prosecutions within a healthcare setting, • Employment in a security/police capacity in a large public institution, • Corporate or medical center security Knowledge and Skills: • Modern police methods and procedures, including crime prevention techniques., • Criminal law, with particular emphasis on apprehension, arrest, and custody of persons accused of misdemeanors and felonies., • Rules of evidence pertaining to search and seizure and the preservation and presentation of evidence in court., • Criminal investigation techniques and procedures, including crime scene investigation, interrogation, fingerprinting and photography., • Familiarity with court decisions on arrest, search, interrogation procedures and the handling of suspects and prisoners., • Maintains a clear understanding of the concepts and philosophy of Community Policing and Problem Oriented Policing., • Use and care of firearms, • Knowledge of common computer software and technology including Microsoft Word, excel, power point, etc., • Ability to learn and master department report management, dispatch and evidence and property procedures, systems and technology., • Understanding of security alarm systems including card access and video image hardware and software., • Must have all special skills or requirements included in the job description for a Security or Special Police Officer., • Willingness to participate in professional associations involving hospital and school security and safety, including the American Society for Industrial Security (ASIS), the International Association for Healthcare Security and Safety (IAHSS) and International Association of College Law Enforcement Administrators (IACLEA). Compensation Range: $30.05- $43.75 This range offers an estimate based on the minimum job qualifications. However, our approach to determining base pay is comprehensive, and a broad range of factors is considered when making an offer. This includes education, experience, skills, and certifications/licensures as they directly relate to position requirements; as well as business/organizational needs, internal equity, and market-competitiveness. In addition, BMCHS offers generous total compensation that includes, but is not limited to, benefits (medical, dental, vision, pharmacy), discretionary annual bonuses and merit increases, Flexible Spending Accounts, 403(b) savings matches, paid time off, career advancement opportunities, and resources to support employee and family well-being. Note: This range is based on Boston-area data, and is subject to modification based on geographic location. Equal Opportunity Employer/Disabled/Veterans According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received only through our website. We do not ask or require downloads of any applications, or "apps" job offers are not extended over text messages or social media platforms. We do not ask individuals to purchase equipment for or prior to employment.

Ethos Risk Services is a leading insurance claims investigation and medical management company, specializing in surveillance and fraud detection. At the forefront, we provide accurate data and actionable insights that translate into better decision-making for our clients. JOB SUMMARY: Our dynamic Ethos team is seeking an Experienced Field Investigator to conduct surveillance and investigative activities to identify potential fraudulent insurance claims. This role involves performing both stationary and mobile surveillance, obtaining video and photographic evidence, and preparing thorough, detailed reports for clients. KEY RESPONSIBILITIES: • Case Preparation: Prepare for surveillance assignment by reviewing Ethos' preliminary reports and case information., • Field Surveillance: Perform covert surveillance from your vehicle by tracking and capturing high-quality video evidence of surveillance targets., • Report Writing: Draft detailed and court-ready investigative reports summarizing activity and key findings., • Documentation: Finalize case file by submitting case reports and uploading video footage via personal laptop at the end of the day., • Communication: Work closely with the field supervisor and operations teams, receiving regular guidance and mentorship. REQUIREMENTS: • Previous Experience: Demonstrated proficiency in covert surveillance techniques, capturing high-quality video footage, and preparing thorough, well-organized investigative reports., • Driver's License: Valid driver's license and proof of automobile insurance., • Personal Vehicle: A well-maintained vehicle that is always reliable (preferably with tinted windows)., • Surveillance Equipment: A handheld camcorder with high-quality zoom and a covert camera device. Use of stabilization equipment (gimbals, tripods, etc.) is strongly encouraged., • Technology: A reliable laptop, cell phone, and internet service are needed for communication and administrative tasks., • Private Investigator License: Active Private Investigator license or willingness to obtain one (where required by state). WORKING CONDITIONS: • While we aim to keep assignments within a 2-hour drive of your residence, occasional further travel and overnight stays (covered by the company) may be required, • Most surveillance cases start at 6:00AM. End time can vary depending on activity and a typical workday can vary from 3-12 hours., • Weekends/holidays are common workdays as claimants are more likely to be active., • This is an independent role often requiring long hours alone in your vehicle, regardless of weather conditions., • Must remain alert with no external distractions, ready to use videography equipment to document subjects. Ethos Risk Services is an equal opportunity employer that does not discriminate on the basis of religious creed, sex, national origin, race, veteran status, disability, age, marital status, color or sexual orientation or any other characteristic. A background check will be conducted, in accordance to the local state law and regulations.

OverviewAlnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their particular expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding portfolio, which spans from rare genetic to common diseases.The successful candidate’s primary role will be as one of the clinical leads in a clinical development program in cardiology and/or cardiometabolic health. He/she will report directly into the program medical lead who provides the clinical research oversight of the program. The Director, Clinical Research is expected to play a leading and influencing role in the overall clinical development strategies for the molecules and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam’s research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs. The Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & Quality Assurance teams to ensure fully harmonized and integrated development strategies. The Director, Clinical Research will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.Key ResponsibilitiesBe the strategic leader providing a strong, clear voice for the clinical programDevelop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvalsOversight of trial conduct and safetyProvide strategic consultation and guidance to Research on all decisions that have significant clinical components and implicationsCollaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plansBe accountable via Clinical Research and Operations for all relevant timelines and deliverablesSupervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materialsBe responsible for final review and sign off with respect to all controlled documents including protocols, investigator brochures, and informed consent formsInfluence internal and external audiences in a high impact, highly visible fashionQualificationsA highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publicationsBoard Certification (or equivalent) or specialist training in cardiology or metabolic disease is desirable3+ years industry experience or equivalent clinical academic experienceSound scientific and clinical judgmentFamiliarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practicesAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesOutstanding leadership and collaboration skills working within a matrix environmentExperience and knowledge of working with biotech/pharma partner(s)Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency.U.S. Pay Range$255,000.00 - $345,000.00The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: About AlnylamWe are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.This role is considered::VirtualDepartment:Clinical Research

OverviewAlnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their particular expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding portfolio, which spans from rare genetic to common diseases.The successful candidate’s primary role will be as one of the clinical leads in a clinical development program in ATTR amyloidosis. He/she will report directly into the program medical lead who provides the clinical research oversight of the program. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the molecules and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam’s research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is anticipated that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs. The Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & Quality Assurance teams to ensure fully harmonized and integrated development strategies. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.*This a hybrid position with 2 days a week onsite presence in our Cambridge, MA or Philadelphia, PA office required.Key Responsibilities• Be the strategic leader providing a strong, clear voice for the clinical program. • Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals. • Oversight of trial conduct and safety• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.• Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.• Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.• Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.• Be responsible for final review and sign off with respect to all controlled documents including protocols, investigator brochures, and informed consent forms.• Influence internal and external audiences in a high impact, highly visible fashion QualificationsA highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publications.Board Certification (or equivalent) or specialist training in cardiologyExpertise in heart failure and/or amyloidosis is desirable3+ years industry experience or equivalent clinical academic experience Sound scientific and clinical judgmentFamiliarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practicesAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesOutstanding leadership and collaboration skills working within a matrix environmentExperience and knowledge of working with biotech/pharma partner(s)Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency. #LI-JB1 #LI-Hybrid U.S. Pay Range$255,000.00 - $345,000.00The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: About AlnylamWe are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.This role is considered::HybridDepartment:Clinical Research

Boston; Remote; San Francisco; Seattle; Vancouver Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. The Director, Clinical Operations will oversee the strategic and operational execution of clinical trials, leading cross-functional teams and collaborating with internal stakeholders and external vendors. This individual will manage trial budgets, vendor selection, and risk mitigation while contributing technical input to key clinical documents. This individual will also mentor staff, foster strong team and cross-functional relationships, and nimbly adapt in our dynamic organization. With proven leadership, financial acumen, and problem-solving skills, this individual will thrive in Jade's dynamic environment and evolve to support broader corporate initiatives. This is an exciting opportunity to make significant contributions to Jade's immunology pipeline, leading trials from first in human single site to global (APAC, LATAM, etc.) phase 3, as assigned. Key Responsibilities • Performs role of Clinical Operations trial lead for assigned trials and leads cross-functional Study Execution Teams, • Develops and executes trial operational strategies and partners cross-functionally to drive trial execution forward; provides strategic and technical recommendations to senior leadership, • Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments and partners with CROs and other vendors to deliver on study execution, • Creates and tracks clinical trial budgets, • Directs risk mitigation, escalation, and resolution activities both internally and with sites and vendors, • Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports), • Builds relationships with clinical sites, vendors, and key stakeholders and maintains an understanding of the external landscape and adjusts plans accordingly, • Represents Clinical Operations in cross-functional activities and supports development and management of the Clinical Operations function, • Mentors more junior team members such as Clinical Trial Associates, • Effectively builds strong internal teams and cross-functional relationships and demonstrates leadership and team building skills, along with success in proactive risk mitigation and problem solving, • Flexible and creative in meeting the needs and challenges of a growing, dynamic company and demonstrates excellent problem-solving abilities, • Strong financial acumen with outstanding track record of building budgets and managing expenses to budget, • Contributes to corporate activities, including preparation of materials for Executive Team and Board of Director meeting materials Qualifications • Bachelors + 15 years of related experience, or Masters + 12 years of related experience, • 10+ years of clinical research experience, including 7+ years of trial management within a biopharmaceutical company; 5+ years within a small/startup company is a plus, • Exceptional clinical trial management skills with a focus on strategic oversight of trial execution on time and on budget, study coordinator and/or site monitoring experience a plus, • Extensive phase 1 through phase 3, global trial management experience, • Immunology and/or rare disease trial management experience, • Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc), • Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials, • Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development, • Experience managing, coaching, and mentoring personnel, • Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration Position Location This is a remote role; periodic travel to team and company events is required. The anticipated salary range for candidates for this role is $215,000 - $240,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

The Associate Director of GCP Operational QA performs advanced GCP Quality Assurance oversight and management activities of clinical trial operations and applicable vendors, to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures and quality standards as set forth in the Quality Management System. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring and trending of quality risks, issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities. • Serve as a key technical resource for the GCP clinical execution function with responsibility of assuring quality risk management/ mitigation and adequacy and compliance with GCP regulatory requirements and guidance to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated, • Liaise with clinical functions and external parties including CROs, Vendors, and investigator sites to promote high level of quality and consistency across and within programs., • Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors., • Participate on Risk Governance Team responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures., • Provide guidance, interpretation and information on regulations, standards and quality systems to GCP functional areas responsible for clinical trial execution., • Develop and measure quality metrics to drive consistent quality standards relating to GCP activities to drive proactive and predictive quality improvements., • Develop and lead inspection readiness activities for assigned programs., • To drive process improvement, provide specialized knowledge and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities., • Participate in the evaluation and selection of GCP service providers., • May provide functional area leadership and management, • Conduct Performance Management (goals, monitoring, reviews), • Participate in Employee Learning and Development (Identification of training needs and support of aspirational goals via IDP), • Talent Acquisition/ Recruiting/Interviewing/ selection, • Onboarding/ Transition/Succession Planning, • Oversight of day to day execution, • May serve as GCP Quality Management System representative, • Participate in collaborative review of impacted SOP/WI, • Review and analyse Key Performance Indicator data and trends, • Analyse risk and proposes remedial, corrective and /or preventive actions, • May participate on process improvement initiatives, • Develop and maintain relationships with GCP Vendors to conform to quality agreements, and participates on applicable Vendor Joint Operating Committees, as needed., • Provides QA review of protocols to identify operational risks and collaborates with study team in development of risk mitigation strategies., • Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies; assess impact of audit finding and other identified compliance risks to subject safety, data integrity and business operations and escalates significant compliance risks, • Manages (and may lead) domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards., • In depth, specialized knowledge of ICH GCP E6 R2 and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.), • Significant experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations, • Current knowledge of industry trends and best practices - for progressive quality risk management in a regulated environment, • Significant technical depth in Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks., • Ability to understand and translate customer needs and develop dynamic or novel solutions to quality management, • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers., • Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy and quality, • Possess a depth of scientific education and specialized knowledge to manage quality oversight for clinical trials; understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects., • Highly proficient in managing complex projects, achieving goals and deadlines, • Significant background in risk management principles and tools to manage risk and risk mitigation activities., • Proficient in using Microsoft Office applications (MS Word, MS Excel, MS PowerPoint, Visio)., • Willing and able to travel up to 15% of working time, • B.S. in a scientific or allied health field, • Typically requires at least 8 years of experience in GCP/GxP Quality Assurance or the required combination of education and experience $160,600 - $240,800 The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Hybrid-Eligible Or On-Site Eligible In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Clinical Pharmacology in our Cambridge, MA office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.POSITION OBJECTIVES:The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases.This individual will work in a highly matrixed team setting and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to support project goals.This individual will contribute to the clinical pharmacology and pharmacometrics strategy to support PDT project progression from entry to clinical development to life cycle managementThis individual will act as the global clinical pharmacology lead on PDT projects and contribute to regulatory submissions and interactions.This role requires a strong strategic thinking, excellent verbal and written communication skills, and in-depth Clinical Pharmacology and PK/PD knowledge.POSITION ACCOUNTABILITIES:Design clinical pharmacology programs to support the development, registration and commercialization of Takeda’s plasma derived products.Represent Clinical Pharmacology on different product development teams. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response, and pediatric development.Leads study design, execution and reporting of clinical pharmacology studiesIdentify, design, conduct and/or oversee pharmacometrics projects to support the program progression and regulatory submissions. The relevent pharmacometrics projects may include and are not limited to: non-compartmental PK, PK/PD analyses, population PK and PK/PD, and other modeling and simulation activities as appropriate for the project.Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory strategies, interactions and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries.Write/Review Clinical Pharmacology Plans and Reports, as well as relevent sections of CSRs.Manage outsourcing activities and approved budget accordingly.Manage contract requisition, SOW and approval of invoices.May participate in identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: A Ph.D., Pharm D, MD or equivalent degree with at least 10 years of clinical pharmacology experience within the pharmaceutical industry.Educational background in clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, or a related field.SkillsDemonstrated ability to successfully manage the clinical pharmacology/pharmacokinetic components of multiple drug products across all phases of developmentDemonstrated ability to successfully manage clinical pharmacology and pharmacokinetic aspects of regulatory agency interactions and label negotiationsAbility to work independently, take initiative and complete tasks to deadlinesAbility to proactively identify issues and solve problems.Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlinesProven ability to work effectively in a matrixed environmentAbility to effectively present information to management at all levels of the organizationDemonstrated ability to set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of PDT R&D strategies.Diplomacy and positive influencing abilitiesExcellent interpersonal, verbal and written communication communication, analytical, and organizational skillsDemonstrated ability to successfully manage external consultants/vendorsKnowledgeDeep understanding and direct hands-on experience with pharmacometrics, PK/PD and statistical analysis using NonMEM, Phoenix NLME and other relevant data analysis tools.Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.Knowledge of the latest developments in clinical pharmacology, pharmacometrics and regulatory guidance documents.Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug productsSound knowledge of GCP regulations and familiarity with GLP and GMP requirementsSound knowledge of the drug development process, and a detailed understanding of non-clinical and clinical DMPK processesSound working knowledge of the cross-functional interfaces that are important for efficient drug developmentExperience in plasma derived/related therapies highly desiredThis position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-JV2Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:USA - MA - Cambridge - Kendall Square - 500U.S. Base Salary Range:$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - MA - Cambridge - Kendall Square - 500Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Reference: R0185147

About Servier Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision. Job DescriptionRole SummaryAs a strategic leader within the Global Biometrics Department, the Director, Biostatistics leads the development and implementation of statistical solutions in clinical trials, evidence generation, and decision making. This role will lead the statistical strategy for assigned clinical development products or evidence generation across our portfolio and may supervise statisticians both in-house and at CROs, ensuring timely and high-quality biostatistics deliverables. In addition, this individual may independently represent Biostatistics in interactions with regulatory authorities or the external scientific community.Primary ResponsibilitiesStrategic Ownership & LeadershipAct as the biostatistics expert and leader, serve as primary statistical representative for cross-functional teams, including clinical, evidence generation, and asset teams, and communicate plans and strategy to subordinatesLead a small team of Biostatisticians, supporting talent acquisition, career development, retention, and resourcing needs in partnership with department leadership, mentor junior biostatisticians in project teamsProvide strategic statistical leadership and oversight for multiple assets or indications. Accountable for the quality and timeline of statistical deliverables, including design, analyses, and interpretation of results. Advocate for resource allocation and ensure efficient utilization of available capacity, optimizing project outcomes and enhancing operational efficiency Propose and advocate for innovative designs and decision-making tools for product development or other evidence generation strategiesLead the evaluation and adoption of appropriate statistical methodologies for design and analysis to optimize study efficiency and increase the probability of technical success.Proactively identify potential statistical risks and develop robust contingency plans to ensure integrity and meeting project milestones.Influence and lead departmental process improvement initiatives and the development and revision of quality documentsRegulatory & Scientific AccountabilityResponsible for interacting with regulatory authorities, other external bodies or scientific community on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations Responsible for the statistical aspects of regulatory documents such as protocols, investigator brochures, study reports, and submission packages as well as integrated reports and summary documents Oversee the publication strategy by reviewing and approving abstracts, posters, and manuscripts Monitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in compliance Develop and standardize key Biostatistics documentation (e.g., statistical sections of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings) Candidate ProfileEducation and Required SkillsPh.D. in Biostatistics or closely related field is required with a minimum of 9 years of relevant pharmaceutical experience. Master’s degree in Biostatistics or related field may be considered with a minimum of 12 years of relevant pharmaceutical experience Broad knowledge and superior understanding of advanced statistical concepts and techniques Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making) Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management Ability to determine appropriate designs and analyses for clinical trials or evidence generation. Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs as needed. Working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices. Working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA) and industry standards applicable to clinical development or evidence generationAbility to respond to regulator or other external body’s inquiries Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed Direct regulatory filing experience is preferred for roles supporting clinical developmentProficiency in SAS is strongly preferred Travel and LocationSome domestic and international travel requiredOnsite in Boston (2-3 days hybrid) or 100% remote with occasional travel to Boston Servier’s CommitmentServier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Salary RangeThe salary range for this role is $204,000-$246,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.

Company Overview:Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: This is a unique opportunity to join a growing Pharmacovigilance team. This PV expert will start as an individual contributor and may have opportunity to grow his/her team over time. Responsibilities include providing strategic scientific and operational PV support for products in the Beam portfolio. The Director of Pharmacovigilance will contribute to a full range of pharmacovigilance activities including but not limited to the oversight and management of safety reports and safety data, signal management activities, PV organization and process development, inspection readiness, PV vendor management, and operational support for Beam products throughout the lifecycle. In addition, she/he will also function in a company matrix environment collaborating with several key groups including but not limited to Clinical Operations, Biometrics, Data Management, Clinical Development, Clinical Science, Regulatory Affairs, Medical Writing, Nonclinical, and Quality.Responsibilities:Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s).Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company.Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs.Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable.Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed.Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings; including coordinating materials, data outputs and presentation, agenda and minutes.Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents; leading cross functional teams to assess safety signals; preparing action and communication plans to mitigate/manage product risks; responding to safety related regulatory requests; developing and maintaining product risk management plans.Support and oversee all vendor activity related to individual case safety reports (ICSR) and case processing, aggregate reports (DSUR, PSUR, and PADERs), expedited reporting, safety database configurations/maintenance, compliance, KPIs, and CAPA management.Lead for DSURs, 6-monthly line listing reports or other aggregate safety reports and oversee reporting compliance.Communicate with partner companies, vendors, and internal group regarding processing and timely exchange of safety reports.Develop training materials and conduct training on PV related content, including presentations at Investigator Meetings and/or Site Initiation Visits, Company trainings, or other trainings, as needed.Contribute to PV vendor-related activities including vendor selection, contracts, scope of work, budgets, safety management plans and other similar process documents, and training and filing documentation, in support of full lifecycle PV activities.Contribute to Quality and Compliance within PV and ensure PV department inspection and/or audit readiness, including TMF support and organization of PV filing systems e.g. Sharepoint.Serve as PV lead for escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions, SMP non-compliance, and the implementation of appropriate corrective actions, as needed.Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions.Manage/contribute to PV agreements with license partners and/or other parties as required, and support such alliances from operational perspective.Contribute to training plans and curricula for cross functional team.Contribute to the development of standards and templates e.g. data outputs, reporting forms, guidance's.Contribute to the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), Investigator Brochure (IB), and/or other product labeling.Support safety database migration activities during PV vendor transitions, and develop process documentation and plans related to PV vendor transitions, as applicable.Participate in departmental and cross functional risk assessment and process improvement initiatives.Maintain knowledge of disease indications for assigned Beam products.Participate in the development of PV organizational strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives.Support organizational leadership in assigned activities and initiatives and actively participate in daily pharmacovigilance activities with a "can-do, hands-on, positive attitude".Other duties, as assigned. Qualifications:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV. Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent).10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV.Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs.Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments.Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems.Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data.Experience in the preparation and authoring of pre- and post- aggregate safety reports.Thorough understanding of the drug development process and context applicable to safety surveillance activities.Ability to execute and follow-through to completion and documentation.Ability to navigate fast-paced and dynamic work environment; ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.Ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure.Excellent communication, interpersonal, and writing skills, including ability to work effectively cross-culturally and cross-functionally with internal and external stakeholders.Independently motivated, detail oriented and good problem-solving ability.Excellent organizational and prioritization skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.Strong organizational and project management skills.Some international/domestic travel may be required.Be ready to embrace the principles of Beam.Onsite requirements: Candidates are expected to come onsite 1-3 days per week.The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.Beam Pay Range$210,000—$260,000 USD

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