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The Senior Research Administrator for the Division of Molecular and Cellular Oncology (MCO) and the Center for Cancer Genomics (CCG) oversees the research portfolios of multiple laboratories, exercising independent judgment while keeping the supervisor, Department Director, and Center leadership informed. In this role, you will partner with faculty and investigators to develop competitive sponsored research applications and manage the financial health of sponsored and institutional funds across operating, federal, industry, foundation, donor, institutional, and clinical trial sources. You will provide senior-level financial planning and management, lead operational process improvements, and cultivate strong business relationships with Cancer Genomics leadership (Directors and Associate Directors). We seek a proactive professional who can drive sustainable long-term planning while responding nimbly to short-term clinical and research priorities, effectively balancing resources across multiple goals and funding streams. The Senior Research Administrator is responsible for collaborating with Institute central offices such as Research Finance, Accounts Payable, Research Administration, Special Funds, Grants and Contracts, the Clinical Trials Office, Office of General Counsel, and the Innovations Office. In addition to grant management responsibilities, the Senior Research Administrator will manage special projects /assignments either within the department or across departments and will represent the Department at Institutional Committees/ Workgroups. The Senior Research Administrator is expected to partner with Department Leadership and Faculty to set strategy and provide guidance and expertise. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. The Senior RA is responsible for the following primary functions autonomously with supervisory input as needed: • Grant Preparation (pre-award), • Portfolio Management (post-award), • Procurement, • Human Resources, • Compliance Portfolio Management (post-award): Responsible for the financial management of sponsored and institutional funds portfolio management. Prepare financial and narrative reports for sponsors while managing and adhering to specified deadlines, provide projection and project summary reports to investigators on a regular basis, ensure spending adheres to budget and sponsor and Institute guidelines, invoice and monitor receivables for clinical trial enrollment when appropriate, establish billing agreements as appropriate, track milestones and receivables for industry agreements. Procurement: Approve and/or initiate purchase requests for investigators and laboratory members via Purchase Orders and PCard. Verify funds are available, expenses are allowable and correctly allocated in a timely manner. Review and approve bills for core and center services. Human Resources: Onboarding - conduct financial analysis to determine availability of funding, assist in the development of job descriptions, post positions, approve salary offers, process visa applications and payments as appropriate. Ongoing - process merit, equity and promotions requests. Manage salary allocations in adherence to funding guidelines and availability. Offboarding - manage termination process checklist, process termination paperwork. Compliance: Partners with faculty and researchers to ensure adherence to internal and external policies. This includes consulting with faculty/OGC/Innovations on MTA, DUA and consulting agreement processes. Also includes advising faculty and researchers and/or referring them to appropriate resources for other compliance issues such as financial conflict of interest and foreign influence. Educate new researchers and manage the federal time and effort process for applicable researchers. Continuous learning and educating of researchers on NIH Grants Policy Statement and DFCI Policies. Review Time and Effort prior to routing to researchers for certification. Cores, Centers and Chargebacks: Assist in pricing development and annual review of pricing, process monthly billing for internal and external customers, manage funds to ensure revenue meets expenditures. SUPERVISORY RESPONSIBILITIES: May advise on the work of others. • Bachelor’s degree preferred, • Computer literacy: Expert with new applications and software programs. Expertise with Excel/Google Sheets preferred., • Organization: Extensive experience with electronic document and email file storage. Able to complete projects with expertise, accuracy and on time. Adept at prioritization and managing multiple priorities simultaneously., • Customer Service: Provides superb written and verbal communication. Demonstrated expertise with listening, inquiry, follow-up, and problem-solving skills., • Critical Thinking: Demonstrated expertise assessing complex situations and developing solutions. Extensive experience analyzing grant data through research, comprehension and application of regulations, policies, and procedures including NIH and other Federal, state and foundation regulations., • Financial: Adept with budgeting principles, including projections and the integration of multiple complex awards and types with varying project periods., • Teamwork and Collaboration: Adept at cultivating relationships with faculty, research staff, department’s GM team, GM in other departments, and central departments., • Institute operations and processes: Adept at directing faculty and researchers to appropriate departmental and institutional resources, including for issues or queries outside the standard scope direct responsibility. In depth knowledge of regulations, policies, and DFCI standard operating procedures (SOPs)., • Inclusion, Diversity & Equity: Promotes inclusive community where human differences are valued and celebrated and where all are welcome. Creates an inclusive work environment that engages and retains talent., • Other: The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA) $89,000 - $101,100 At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. EEOC Poster

Job Description R&D Partners is seeking to hire a Senior Clinical Supply Chain Planner in Cambridge, MA. Your main responsibilities as a Senior Clinical Supply Chain Planner: · Managing packaging, labeling, and distribution of clinical trial material for global clinical trials · Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material. · Utilize and support the management and use of home-grown budget forecasting and planning tool · Partner with Clinical Operations to align on demand assumptions · Develop supply strategies to maximize supply efficiency and minimize waste What we are looking for in a Senior Clinical Supply Chain Planner: · BS degree in Life Sciences or Supply Chain Management · Experience: Minimum 3+ years of experience in clinical supply · Understanding of end to end clinical supply chain activity · Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc) · Experience with IRT systems Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO &, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval Pay Scale: $83,200 – $104,000 Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r\n\r\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\r\n\r\nOur life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

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 . Job Summary As a Senior Medical Director, reporting to our Chief Medical Officer, you will guide and support clinical programs, bringing together your medical expertise, collaborative mindset, and ability to inspire cross-functional teams. You will shape the clinical development plan for new compounds, co-design and oversee clinical studies, and partner with Program Teams across Research & Development to map the path toward regulatory approval. You’ll work closely with colleagues across all phases of development, lead discussions with academic study investigators, engage with opinion leaders, and represent C4T with Health Authorities. A genuine passion for advancing science, a talent for uniting diverse perspectives, and a shared commitment to improving the lives of patients with cancer will be key to success in this role. Your Role • Drive development programs, collaborating with Program Management, Clinical Operations, Regulatory Affairs, and cross-functional teams, collaboratively designing and refining oncology clinical study protocols from first-in-human Phase I through pivotal studies supporting regulatory submissions., • Serve as a medical monitor for multiple clinical trials in relapsed refractory multiple myeloma, ensuring high-quality evaluation of clinical and laboratory data, guiding decision-making on recruitment, study conduct and on dose escalation and early clinical signals of activity if appropriate to trial stage., • Provide input and leadership in preparing global regulatory filings, including clinical sections of Investigator’s Brochures (IBs), Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Applications (NDAs)., • Facilitate regular engagement with academic clinical investigators, support site initiation visits, and lead investigator meetings in a way that fosters collaboration, trust, and shared learning., • Partner with Pharmacovigilance to review and interpret clinical data, ensuring accuracy, context, and patient safety., • Represent C4T with the scientific community, contribute to publication plans, and build relationships with external experts to inform program strategies. Your Background Required: • A M.D. with experience in adult hematological oncology, plus at least two years of clinical development experience in biotechnology or pharmaceutical settings (or equivalent combination of academic and industry experience)., • Knowledge of drug development from IND through NDA, including experience with companion diagnostics, clinical operations, and pharmacovigilance., • Experience designing and delivering early- and late-stage programs, including proactively addressing challenges and aligning teams toward shared outcomes., • A flexible contributor who can balance strategic vision with hands-on execution., • Skilled communicator who listens actively, adapts to diverse audiences, and builds understanding across teams and stakeholders. C4 Therapeutics is an Equal Opportunity Employer.

Job DescriptionSenior Research Administrator Job Description Manage a complex and large portfolio of research grants and be responsible for both pre and post award functions. Responsibilities • Manage a complex and large portfolio of research grants., • Handle pre and post award functions for research grants., • Ensure effective grants management and compliance with regulations., • Support clinical research initiatives., • Communicate effectively with team members and stakeholders., • Experience in grants management, including pre and post award functions., • Understanding of clinical research and clinical trials., • Strong communication skills., • Proficiency in data entry and record management., • Experience working within a medical oncology department is advantageous. Renowned for its commitment to cutting-edge research and excellent patient care., the team consists of 14 members, including directors, managers, and research administrators. Work one day per week remotely (preferably Thursday, but flexible). The team is supportive, encouraging questions, and fostering a friendly and outgoing atmosphere. Job Type & Location This is a Permanent position based out of Boston, Massachusetts. Hybrid schedule- 4 days remote and 1 day on-site. Pay and Benefits The pay range for this position is $100000.00 - $112000.00/yr. The company will discuss benefits information with the candidate upon offer letter. Workplace Type This is a hybrid position in Boston,MA. Application Deadline This position is anticipated to close on Oct 14, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionCompany Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Massachusetts, US. For more information, visit bicycletherapeutics.com. Culture is key and all Bicycle employees actively embrace and role model our company values: • We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients., • We are Dedicated to our Mission. You can’t change the world if you don’t have determination., • We are One Team. We only succeed when we work together. Job Description Scientific Strategy & Innovation • Participate in strategy, design, authoring, and review of clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plans, • You will provide scientific input into the design of clinical protocols, amendments, and related documents., • You will stay current with the scientific literature and competitive landscape in order to contribute to clinical development strategy., • Perform literature searches and critically review and summarize results to support activities such as document development, new indications for a given molecule, and competitive intelligence, • Contribute to clinical study design and conduct for development of novel tumor antigen-targeted Bicycle® therapeutics, • Lead medical and safety data review and associated meetings in collaboration with the Medical Monitor, review and query data, • Participate in study start up, including identification of investigators/sites, feasibility, review of CRF, etc, • Develop content and give presentations during site initiation visits; participate in site training, • Support internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigation, • You will lead complex clinical science activities for assigned studies, serving as the primary scientific point of contact to ensure program goals are successfully met., • You will oversee and analyze clinical trial data on an ongoing basis, identifying and contributing to interpretation of trends to support clinical decisions and study conduct., • You will author and review key clinical and regulatory documents, including protocols, Investigator's Brochures (IBs), clinical study reports (CSRs), and sections of regulatory filings (e.g., INDs, NDAs)., • Contribute to regulatory documents, including INDs and briefing books and other regulatory documents, • Contribute to publication strategy and provide support for publication of data, • You will ensure data integrity and compliance by participating in the development of case report forms (CRFs), data review plans, and statistical analysis plans., • Serve as a liaison between study team, CROs, and investigators, • Assist in preparing material for advisory boards, conference activities, external collaborations, and partnerships, • Potential to mentor other clinical scientists, • Attend congresses as needed to support publications as well as interactions with key opinion leaders and investigators, • You will act as a core partner to Medical Monitors, Clinical Operations, Biostatistics, Translational and Regulatory Affairs, ensuring seamless cross-functional execution., • You will build strong relationships with clinical investigators and key opinion leaders, acting as a key scientific representative for Bicycle.Qualifications, • Advanced scientific or clinical degree (e.g., MS, PhD, PharmD, nursing, or equivalent) with experience in a clinical science or clinical development role within the biotech or pharmaceutical industry., • Ability to be onsite on a hybrid basis, • Experience in the design and execution of clinical trials, with a deep understanding of protocol development, data analysis, and study reporting., • Thorough knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development., • Demonstrated ability to interpret complex scientific and clinical data and translate it into actionable strategies., • Experience in oncology is essential., • Core Expertise: You are a subject matter expert in clinical science, applying specialized experience to guide teams and projects., • Data / Insight: You provide interpretation of clinical data and its implications, using your analysis to make significant recommendations., • Task / Project Delivery: You lead large, complex clinical projects or programs that directly impact company success., • Problem-Solving: You are a proficient problem-solver, developing innovative solutions to complex scientific and operational challenges in clinical development., • Autonomy: You operate with high independence, setting the scientific direction for your assigned clinical studies and making key decisions with limited guidance., • Decision-Making: You make significant decisions within broad guidelines, exercising sound judgment in data interpretation and study conduct., • Collaboration (One Team): You build strong, collaborative partnerships across all functions of clinical development, creating an environment that empowers teams., • Innovation (Adventurous): You are ambitious in driving positive change, encouraging creative thinking and experimentation in clinical study design., • Accountability (Dedicated to our Mission): You ensure team outcomes align with our mission priorities, demonstrating passion for delivering impactful results for patients. Additional Information • Flexible working environment, • Competitive reward including annual company bonus, • Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company, • Health and Dependent Care Flexible Spending Accounts, • 401(k) plan with a 4% Company match and immediate vesting, • Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days, • Employee assistance program, • Employee recognition schemes, • 10 Company holidays, • Competitive Family Leave Policy Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

Job Description Senior Medical Director, Clinical Development DynamiCure is seeking a talented, independent, and motivated clinician to help build our clinical development group. You will join a small but growing clinical development group contributing to the medical function, including designing, implementing, and communicating global clinical development plans for our vascular normalization and tumor microenvironment programs. You will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as DynamiCure’s senior management and Board of Directors. As a key contributor you will be a thought partner with the VP of Clinical Development for innovative oncology development strategies, as well as a collaborator with discovery, preclinical and translational researchers focused on development of novel vascular normalization and TME modulators. Reports to: VP, Clinical Development Travel expectations: 20% Key Responsibilities and Activities • Provide oncology drug development expertise to an expanding oncology portfolio, all developed and discovered within DynamiCure., • Provide sound clinical development guidance to key stakeholders across DynamiCure., • Ensure that scientific rigor and innovation continues to be integrated into and drives DynamiCure’s oncology development strategies., • Excellent scientific standing among peers and the ability to address issues with a very high level of scientific rigor and creative solutions., • Adeptly translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study., • Assist in driving the timely execution of multiple assets and studies within the oncology portfolio., • Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleagues., • Work closely with regulatory leaders to support regulatory submissions and develop regulatory strategies., • Responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports., • Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials., • Responsible for analysis of clinical data, including safety monitoring in collaboration with PV., • Develop and maintain relationships and serve as medical liaison with key opinion leaders and PIs., • Organize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings., • Demonstrated capability to lead cross-functional teams., • Able to provide leadership and mentor more junior members of the clinical development team., • Able to present DynamiCure programs to external parties and contribute as needed to business development efforts. Required Education, Experience, Skills, and Competencies • M.D. or D.O. degree and clinical oncology experience required & at least 5 years’ experience working in the biotech and/or pharmaceutical industry; board certification/eligibility in oncology and MD/PhD are strongly preferred., • Hands-on oncology or I/O drug development experience within industry oncology in pharmaceutical and/or biotech company setting either for small molecules or large molecules, • Proven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials., • Knowledge of carrying out oncology clinical trials, including knowledge of current treatment landscapes., • Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the goals of DynamiCure., • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators., • Proven track record of strong collaboration skills and the ability to partner with others to implement innovative oncology development strategies., • Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills., • Ability to think critically and demonstrated troubleshooting and problem-solving skills., • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Why Work for DynamiCure Around the Office: • Flexible scheduling around core hours, • Casual dress code, • Unlimited drinks & snacks Benefits: • 20 days Paid Time Off, • 10 paid holidays plus Winter Break, • Paid Family Leave, • Full benefits package including:, • Medical, • Dental, • Vision, • HSA Account with Company contribution, • 401(K) with up to 5% match, • Company paid life and AD&D insurance, • Supplemental life & AD&D insurance, • Company paid short- and long-term disability insurance, • Employee Assistance Program Employee Programs: • Employee Referral Program, • Employee Assistance Program We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law. 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Job Description Job Title: Vice President, Head of Clinical R&D (HoC) Reports to (title): CMO Summary: The HoC works as a strategic partner with the CMO, and other members of the Executive team to provide strategic direction and technical leadership to the clinical R&D and clinical scientist groups and is responsible for the overall management, direction and performance of Phase I-IV for drug products, including: overseeing clinical development and pharmacovigilance according to agreed-upon deadlines and budgets, clinical trial design, implementation and execution, clinical research, data analysis and management. The HoC also provide strategic direction and technical leadership to the clinical R&D and clinical scientist groups in their role to guide translational development and clinical guidance and planning for Lead and IND Candidate programs as well as for evaluation, input and direction on potential partnering/business development opportunities. The HoC works in partnership with the CMO to establish the clinical research vision and regulatory roadmap for the company including standards and policies designed to ensure the quality and outcomes of compounds under development. The HoC in collaboration with the CMO and the rest of the Executive team will have over-arching responsibility for the successful clinical development of Solid’s pipeline programs including development of a clinical roadmap for all compounds. Key Duties & Accountabilities: • Provide oversight and leadership of the various functional areas: Clinical R&D (medical directors and therapeutic area heads), clinical science, medical monitoring, pharmacovigilance, • Work collaboratively with the Research function, providing input into design of preclinical trials to support drug products from Lead through candidate phase as they enter in the clinic and including but not limited to CDP development, TPP development and IND/CTA clearance along with associated activities., • Close collaboration with Patient Advocacy to ensure patient centricity from product conception, through clinical trial conduct into and through commercial launch and to work collaboratively to ensure the voice of the patient is represented in all decisions and actions and to ensure the voice of the physician is appropriately presented., • Experience managing multiple programs across multiple geographies, • Input into the development of key marketing materials., • Research and identify new opportunities and novel therapeutic opportunities that augment the company’s mission, vision, values, and goals, • Establish and maintain relationships with principal investigators and KOL’s to ensure that the Company has a clear understanding of clinician needs and requirements., • Represent and manage communication of Solid’s clinical and regulatory programs to diverse audiences including: the executive team, regulatory agencies including the FDA and EMA, investors, Board of Directors, and other key stakeholders., • To assist in communications with other pharmaceutical companies and partners to identify and implement collaborative studies, regulatory activities, and other programs that align with the company’s strategy and goals., • Attract, motivate, retain and lead a highly skilled clinical development and regulatory team., • Maintain current understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific presentations and reviewing relevant literature., • Other related ad hoc duties and projects as required., • Dedicated to maintaining and or adapting our clinical R&D structure and cross functional matrix relationships that empower colleagues, leverage and optimally harness their talents and maximizes their opportunities for promotion and advancement, • Board Certified MD with medical research and drug development experience., • MD with regenerative medicine (such as AAV) preferred, • MD with experience in neuromuscular and or cardiovascular rare disease space preferred., • Proven leader of high potential high performing teams., • Prior experience in clinical development leadership roles (preferably global experience) across all phases of clinical studies. Demonstrated capabilities leading clinical programs to successful filing and approval in both US and globally., • Experience interacting with the FDA/EMA and knowledge of GCP clinical requirements, general regulatory requirements, and relevant regulatory guidance documents pertinent to the Company., • Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. Ability to develop strong relationships with Executive team and Board of Directors. This role should have an expectation of 20% travel and may require significant travel on an ad hoc basis. Local to Boston / Charlestown MA strongly preferred

Job DescriptionCompany Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway 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 individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies designed to develop innovative therapies for people with rare neuroendocrine diseases. The position will be responsible for overseeing components of study execution and as such will routinely interact with the medical, translational research, regulatory, biostats and diagnostic groups to ensure deliverables are met. Responsibilities and Duties • Manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge, • Provide trial cost estimates and timelines as part of CDP development, • Drive execution of clinical trials from protocol design to the final clinical study report for specified studies., • Effectively communicate with Key Opinion Leaders, • Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, • Oversight of study quality and GCP compliance, • Assist in the development of contingency/risk management plans and associated mitigation strategies, • Oversee and coordinate with document specialists regarding study files and Trial Master File (TMF) quality checks, including oversight of junior team members, • Prepare budgets, timelines, and forecasts for assigned clinical studies, • Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities, • BA/BS degree, advanced degree preferred, • 5+ years of relevant experience within a CRO, pharmaceutical, and/or biotech company, • Experience working on Phase I - IV multinational clinical studies, • Regulatory knowledge, including Good Clinical Practices (GCPs), • Knowledge of global clinical trial management in CRO outsourced environment, • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability, • Excellent communication skills (written and verbal), • Ability to assemble a plan and execute on the details, • Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project 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 Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts. Powered by JazzHR ZXyWPCoe0I

Job Description Location: Everett, MA; hybrid 20/20 Onsite is a leading healthcare services company, focused on mobile and on-site delivery of eye care. Since 2014, our Mobile Vision Clinics have provided eye care to over 75,000 patients at their workplaces, schools and neighborhoods. In May 2020, we expanded our services to provide vital access to clinical trial assessments and tests, bringing uniquely equipped Mobile Clinics directly to participants. Our focus is “radical patient-centricity”, prioritizing the patient experience, minimizing time and distance barriers. By building relationships with pharmaceutical companies, CROs, and trial sites, we are driving the shift towards decentralized and hybrid clinical trials that put the patient at the heart of the clinical research process. Our delivery model and platform are proven to transform patient experience, reduce friction, increase convenience, and produce high levels of patient engagement and satisfaction with services offered. 20/20 Onsite acts as a natural partner for Life Sciences entities who can realize numerous benefits from our model including accelerated enrollment, improved adherence of timelines and budgets and enhanced trial data consistency and quality. 20/20 Onsite services have become instrumental in advancing drug therapy development and distribution, chronic disease management, and essential patient health care in the sponsored communities the company serves. Our established client base is highly satisfied with our services, shows indications of follow on business opportunities, and in almost every case represents a major growth opportunity for our company The Opportunity We are seeking an experienced Controller with strong finance expertise to oversee, manage and grow the financial operations of 20/20 Onsite, supporting US-based clients. Reporting to our Fractional CFO, this role will play a critical part in shaping the company’s financial strategy and function, providing insights, forecasts, and analysis that drive operational performance and business growth. The Controller will directly manage the Accounting team, ensuring accuracy, compliance, and efficiency across all reporting, while also leading budgeting, forecasting, and financial planning activities. This is a great opportunity for someone who wants to build and manage the finance function at a rapidly growing, leading Life Sciences company. Key Responsibilities • Oversee the month-end close activities including journal entries, reconciliations, and preparation of financial statements., • Oversee accounts payable, accounts receivable, and related compliance requirements., • Manage and provide direction to the accounting and finance team., • Prepare and present consolidated monthly, quarterly, and annual financial statements and operational reports for leadership., • Manage financial planning, budgeting, and forecasting processes, aligning projections with operational priorities and strategic goals., • Utilize financial models, KPIs, ROI analysis, and scenario planning to support decision-making around new initiatives, service lines, and market expansion., • Monitor and analyze cash flow, working capital, budgeting, and forecasting activities to support operations., • Ensure compliance with US GAAP, federal and state regulations, and healthcare-specific requirements such as HIPAA and IRS guidelines., • Partner with operational teams to analyze costs and margin insights, optimize service delivery, and improve profitability., • Oversee vendor payments, supply chain-related financial processes, and vehicle/medical equipment expenditures., • Evaluate, improve, and maintain financial systems, accounting and reporting processes, internal controls and accounting policies., • Provide leadership in financial modeling, ROI analysis, and strategic planning for new business opportunities and expansion., • Coordinate and manage external audits, ensuring timely and accurate reporting., • Mentor and develop accounting staff, fostering accountability and continuous improvement., • Bachelor’s degree in Accounting, Finance, or related field required., • 7–10 years of progressive Accounting/Finance experience, • 3 years in a management role and at a revenue generating organization., • Strong technical knowledge of US GAAP and financial reporting requirements., • Life Sciences (Clinical Research, Pharma, Biotech) industry experience is strongly preferred., • Proficiency in financial/accounting systems (QuickBooks, NetSuite, or similar), advanced Excel and financial modeling skills., • Demonstrated ability to deliver both tactical accounting accuracy and strategic financial insights., • Strong leadership, analytical, organizational, and interpersonal skills. 5gHVBV1Cgx

Job Description We are seeking a highly experienced Data Management professional to oversee and execute all aspects of clinical data management across our clinical studies. This role will ensure the accuracy, integrity, and timeliness of clinical trial data, liaising with internal teams and external CROs to support clinical development and regulatory submissions. The ideal candidate has extensive experience with eCRF development, database build and validation, data review and reconciliation, and regulatory documentation. Key Responsibilities: • Oversee all data management activities conducted by CROs from study start-up through database lock., • Lead eCRF development and cross-functional reviews of eCRF content., • Manage database build activities, including review of edit check specifications and performance management of user acceptance testing (UAT)., • Monitor ongoing data collection, ensuring accuracy of individual subject data and datasets generated for interim analyses, publications, CSRs, DSURs, IBs, and other business needs., • Oversee database lock, archiving of study data, and ensure compliance with regulatory requirements., • Review and provide input to clinical protocols/amendments, clinical study reports, and statistical analysis plans., • Manage and review Data Management Plans to ensure consistency across clinical studies., • Participate in internal reviews of eCRF completion guidelines and other clinical trial documents., • Support the definition, review, and testing of randomization systems and integration with clinical databases., • Define specifications for final database structures and manage the transfer of data from multiple vendors., • Perform reconciliation between eCRF data and external databases, including serious adverse events and translational data., • Create and deliver in-process data reports to support decision-making in clinical trials, including safety reviews., • Liaise with safety vendors to ensure appropriate reconciliation of clinical databases., • Represent Data Management in cross-functional team meetings and vendor interactions, effectively communicating requirements, strategies, metrics, timelines, and deliverables., • Assist in drafting and reviewing project timelines to ensure deliverables and milestones are met., • Establish best practices and develop data management SOPs and processes as required., • Collaborate with cross-functional leaders to prepare clinical study reports and other regulatory documents, including BLA submissions., • Support GCP inspection readiness in all data management domains. Qualifications: • Bachelor’s degree in Life Sciences, Computer Science, or related field (advanced degree preferred)., • Extensive experience in clinical data management across Phase I–III trials., • Expertise in eCRF design, database build, data validation, and reconciliation., • Strong knowledge of regulatory requirements (GCP, ICH, FDA/EMA guidelines)., • Experience managing CROs and cross-functional teams., • Excellent communication and leadership skills., • Strong analytical and problem-solving abilities. Preferred Skills: • Experience with CDISC standards (SDTM/ADaM)., • Experience with data visualization and reporting tools., • Prior involvement in regulatory submissions (CSRs, BLAs). Company DescriptionBeacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.\r\n\r\nBeacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.\r\n\r\nWhether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.

Job Description Clinical Scientist – (~20 hours/week average) Position Summary: The Clinical Scientist will report to the Medical Director within the Clinical Development function. This individual plays a central role in executing clinical development plans and trial strategies in close collaboration with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Drug Safety. The Clinical Scientist provides scientific and operational support across the full lifecycle of clinical trials — from protocol development through study execution, data interpretation, and dissemination of results. Key Responsibilities: • Collaborate with the Study Medical Lead to support program clinical development plans, including:, • Planning and execution of clinical trials, • Development of data collection, review, and interpretation processes, • Interpretation and presentation of study data for safety and efficacy assessments, • Partnership with safety teams to support ongoing review and communication, • Preparation of internal and external scientific materials (e.g., DMC/Steering Committee presentations, manuscripts, review articles), • Contribution to clinical documents including study reports, Investigator Brochures, narratives, and regulatory submissions (e.g., INDs, NDAs, briefing packages), • Conduct literature reviews and summarize findings to support program decision-making, • Support internal and external training initiatives related to protocol design and clinical development processes, • Serve as a liaison with internal and external experts to align study execution with protocol intent; may lead endpoint-specific or medical training, • Assist with planning and delivery of materials for Investigator Meetings and Scientific Advisory Boards, • Develop and contribute to DMC/adjudication charters and assist in related meetings and deliverables, • Provide cross-functional scientific support to internal teams and partners as needed Qualifications: • Bachelor’s degree in Life Sciences or related field required; advanced degree (e.g., MS, PhD, PharmD, RN) preferred, • Minimum of 5+ years of experience in clinical research or drug development, • Hands-on experience in clinical study execution and data review, • Familiarity with domestic and international clinical trial design and reporting standards, • Knowledge of GCP, ICH, and regulatory frameworks, • Strong independent and collaborative working skills, with ability to operate in fast-paced and cross-functional environments, • Demonstrated planning, critical thinking, and time management capabilities, • Excellent communication and presentation skills, • Proficiency in clinical and data tools such as Spotfire®, R, GraphPad Prism, or similar platforms Physical Requirements: • Ability to work at a computer or lab bench for extended periods, • Visual and manual acuity for data analysis and keyboard-based tasks, • Occasional domestic and international travel required Company DescriptionBeacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.\r\n\r\nBeacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.\r\n\r\nWhether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Senior Region Manager assumes overall responsibility for the management of sites assigned. This individual's responsibility spans the entire functionality of the sites to include personnel management, site profitability and the successful conduct of all studies while providing a high-quality point of intersection for staff, study participants, CROs and sponsors. The Senior Region Manager provides leadership and oversight of site operations according to CARE SOPs, GCP and FDA/ICH Guidelines. The Senior Region Manager serves as a cross functional team lead and is an expert resource for all Region Managers. How You'll Make An Impact • Personnel, • Travel to each site within the region and meet with team members (including PI) face-to face (quarterly at minimum), • Conduct regular site and Region team meetings, • Meet with PI regularly (bi-weekly at minimum), • Ensure all training is up to date, • Conduct weekly 1:1 meeting with each direct report, • Review performance and KPIs, • Ongoing employee development and mentoring, • Maintain appropriate documentation for each direct report, • Provide timely evaluation of areas needing improvement and assist in developing a plan for improvement with staff member with objective measurable goals, • Escalate issues appropriately to ensure they are addressed in a timely manner. Engage HR and Director of Site Operations if necessary, • Carry out disciplinary process as required, • Manage underperformance proactively, • Work with HR to implement Performance Improvement Plan (PIP) if necessary to clearly outline the path to employee success, • Conduct annual performance appraisals and have goal setting and milestone meetings regularly throughout the year with employees to discuss progress, • Ensure HR policies are implemented and maintained at all sites, • Ensure that all staff are up to date on annual training and documentation is in their record, • Encourage a positive team-oriented environment at each site in the region, • Ensure high staff morale and low turnover rates, • Ensure time sheets are reviewed and submitted in the required timeframe for non-exempt employees, • Review all travel and expense requests to ensure they are within policy prior to approval, • Work with the Director of Site Operations to review and address injury reports if necessary, • Mentor and train new Region managers; be a resource to all RMs and liaison between Leadership, Physicians and RM team, • Region motivator and morale builder; work with Director of Site Operations to develop and implement incentive programs for staff to foster interdepartmental collaboration, teamwork, motivation and excellent participant experience., • New Staff, • Review potential candidates and conduct interviews for all roles within assigned region and provide timely feedback, • Onboard new employees at all assigned sites., • Complete the new hire checklist for each new employee, • Meet with new employees daily during their first week of employment to review expectations and progress on assigned training, • Meet all new employees on site during their first week of employment., • Ensure all Care Access training is complete prior to requesting study specific training, • Provide additional training resources, if applicable, • Management of Studies and Site Workload, • Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols, • Review protocols to anticipate special needs regarding staff (unblinded, assessors) procedures, outside services and/or costs, • Ability to perform the duties of a Clinical Research Coordinator and actively performs CRC responsibilities at sites, • Coordinate Investigator and Sub-Investigator coverage, • Attend Site Evaluation Visits, Site Initiation Visits in person or remotely, • Regularly assess and adjust workload for site staff to ensure the success of each study, • Work closely with the Study Start Up Team to ensure timely study start-up and activation of new trials, • Ensure study required training has been completed by staff and PI, • Update Director, Site Operations on all pending and active study details, • Be available as a resource to provide expertise on protocols, • Work closely with internal recruitment and marketing teams to ensure recruitment activities are optimized for all studies, • Represent Site Network on new projects, • Conduct weekly Site Network Leadership meetings, • Regularly review metrics for all sites in the region and ensure information is accurate and study goals are being met, • Ensure source is reviewed timely for all new studies, • Quality, • Oversee all CRC's work to ensure QC is performed, data is entered, and all queries are resolved in a timely manner, • Create and implement processes that will enhance and improve workflow; minimize deviations, minimize no-shows, benefit overall functionality at each site in the region. Work with Director of Site Operations as processes may be implemented at other locations, • Participate in all internal and external audits; play an active role in their management, • Work directly with the site teams to address items on monitoring reports and Care internal audit reports in a timely manner, • Ensure all Quality Issues at the sites are reported via QMS timely, • Work closely with Operational Compliance and Quality Assurance teams; participate in Root Cause Analysis (RCA) and ensure timely execution of all required actions, • Maintain a calendar of all monitoring visits (including internal audits), • When possible, meet with CRAs during their monitoring visits (remotely or in person), • Routinely review all monitoring follow-up letters for action items and quality trends; ensure timely completion of all action items, • Financial, • Work closely with the Business Development team to ensure the timely responses to feasibility questionnaires and scheduling of Site Evaluation Visits as appropriate, • Keep Director of Site Operations apprised of any study changes and all study related issues that affect the revenue generation at the sites, • Work closely with Director, Site Operations to review site P&L and make adjustments as needed, • Ensure the proper maintenance of participants W-9s to support annual 1099 filings, • Coordinate site staff to cover workload at each site, • Decrease hourly staff when appropriate, • Apply coverage when short staffed, • Site Maintenance, • Keep Director of Site Operations apprised of any site maintenance issues, • Coordinate building and equipment maintenance, • Ensure sites are kept clean and organized, • Region safety resource- knowledgeable on applicable state and federal regulations/OSHA fostering a safe work environment for all staff. Ensure all staff are following OSHA guidelines., • Ensure that sites have the equipment necessary to safely perform job responsibilities, • Review monthly checklists submitted for each site. Ensure there are no lapses in equipment calibration., • Regularly assess space needs and work closely with Director, Site Operations to identify new/additional space, if needed, • Oversee and actively participate in new site builds and decommission of sites, • Community Engagement, • Develop Partnerships with local providers and community leaders, • Coordinate and participate in community events and patient education considering Care's diversity initiative in each region, • Development and implementation of strategic recruitment and targeted community outreach, • Meet regularly with existing community and provider partners to ensure understanding of current studies at their local site. Assist with identifying eligible patients based on inclusion/exclusion criteria, • Order and maintain marketing materials for the patient population for each partner/site., • Develop a strategy for each site to promote site growth and expansion including developing new partnerships of motivated potential community members., • Work cross functionally to develop and onboard new physician partners to include PI's, Sub-I's and Trial Access Partners. Ensure investigators are being paid appropriately. The Expertise Required, • Excellent working knowledge of medical and research terminology Must have a client service mentality, • Excellent working knowledge of federal regulations, good clinical practices (GCP), • Ability to communicate and work effectively with a diverse team of professionals, • Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments, • Communication Skills: Strong verbal and written communication skills, • Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals, • Strong computer skills with demonstrated abilities using clinical trials database, IWRS, electronic data capture, MS word and excel, • Ability to balance tasks with competing priorities, • Critical thinker and problem solver, • Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done, • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure, • High level of self-motivation, energy and possess a high degree of urgency, • Ability to work independently in a fast-paced environment with minimal supervision, • Ability to adapt to frequent changes in responsibilities and workloadsCertifications/Licenses, Education, and Experience:, • Bachelor's Degree preferred, or equivalent combination of education, training and experience., • A minimum of 2+ years of relevant management experience, • A minimum of 3+ years prior Clinical Research Coordinator experience required, • 2 years' experience as a Care Access Research Clinical Research Coordinator is preferred, • 1 year experience as a Care Access Region Manager is preferredHow We Work Together, • Location: Remote within the United States. This role requires up to 50% travel., • Travel: Must be willing to travel up to 50% of the time nationwide. Frequency and length of travel may depend on the length and project requirements., • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.Benefits & Perks, • Paid Time Off (PTO) and Company Paid Holidays, • 100% Employer paid medical, dental, and vision insurance plan options, • Health Savings Account and Flexible Spending Accounts, • Bi-weekly HSA employer contribution, • Company paid Short-Term Disability and Long-Term Disability We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job Title: Vice President, Clinical Operations Location: Boston, MA (Hybrid) Company Size: Small-to-Mid-Sized Biopharmaceutical Company Therapeutic Areas: Immunotherapies & Oncology About the Company: The client is an innovative, fast-growing SME biopharmaceutical company based in Boston, focused on developing next-generation immunotherapies and oncology treatments. With a collaborative, mission-driven culture, the company is advancing a pipeline designed to transform outcomes for patients with cancer and immune-mediated diseases. Position Overview: The client is seeking a Vice President of Clinical Operations to assume a senior leadership role overseeing all aspects of clinical trial execution across their oncology and immunotherapy programs. This executive will be responsible for building and scaling the Clinical Operations function, ensuring the delivery of high-quality, timely, and cost-effective clinical studies. The VP will play a key role in shaping clinical strategy, leading teams, managing vendors, and advancing the pipeline through early-stage and pivotal trials. Key Responsibilities: • Provide strategic and operational leadership for all clinical operations activities across oncology and immunotherapy trials., • Oversee planning, initiation, and execution of Phase I–III studies in alignment with corporate strategy and regulatory standards., • Build, mentor, and lead a high-performing Clinical Operations team., • Partner closely with cross-functional stakeholders (Clinical Development, Regulatory, Biometrics, CMC, Medical Affairs)., • Lead vendor selection, contract negotiations, and budget management., • Develop and refine operational processes, SOPs, and quality systems., • Represent Clinical Operations at the executive level and provide updates on portfolio progress, risks, and mitigation strategies., • Ensure compliance with ICH-GCP, FDA, EMA, and other global regulatory requirements. Qualifications: • Advanced degree in life sciences (MS, PharmD, PhD, MD, or equivalent preferred)., • 15+ years of progressive clinical operations experience within biotech/pharma, including significant experience in oncology and/or immunotherapies., • Proven track record of leading trials from early development through pivotal studies and regulatory submissions., • Leadership experience at VP or senior director level in an SME/biotech environment strongly preferred., • Expertise in vendor oversight, budgets, and CRO management., • Deep knowledge of ICH-GCP and global regulatory requirements., • Strong leadership skills, both strategic and hands-on., • Excellent communicator with the ability to influence across all levels. The Offer: The company offers the opportunity to make a significant impact within a growing biopharmaceutical SME that is advancing cutting-edge oncology and immunotherapy programs. The successful candidate will join a collaborative, science-driven leadership team and will have visibility at the executive and board level. A highly competitive compensation package is available, including base salary, performance-based bonus, equity participation, and comprehensive benefits. This role also provides the professional growth and influence that comes with building and scaling a function within an ambitious, forward-looking organization.

Job Description Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. We are looking for an experienced Customer Success pro who thrives in a fast-paced environment. Customer success is the value organization of Datavant Life Sciences. We are accountable for driving meaningful, measurable outcomes for our customers by aligning our products and services with their strategic objectives—maximizing value, accelerating time to impact, and fostering long-term, expansive relationships. As such, we need an experienced relationship management individual who can drive success for our customers. This role includes responsibilities for Customer Success outcomes (e.g., value realization, customer satisfaction, renewals, etc.) and activities (e.g., delivery, adoption, advocacy, retention, etc.). You Will: • Own account management and value management for a dedicated account portfolio of up to 15 accounts in our biopharma segment, with a special focus on end-to-end accelerating value within your portfolio., • Lead with curiosity and dive deep into learning and understanding the goals and strategies of our customers and how our solutions and products support those goals, • Excel in advanced program management and decision-making, balancing thoughtful analysis with speed to execution, appropriately prioritizing, and knowing when and how to escalate complex edge cases effectively, • Influence future lifetime value through higher product adoption, customer satisfaction and overall health scores, • Thrive in a fast-paced, continuous improvement environment, embracing gray areas and ambiguity, while seeking to drive clarity and scalability for your customers and the business, • Work effectively with your cross-functional partners - surfacing insights that influence product and sales strategies across account teams for your portfolio accounts., • Take a self-service-first approach to problem solving and navigating questions internally and externally, • Be a proven communicator and presenter with a commitment to maintaining good internal and external relationships through passion, empathy, and hard work, • 7+ years experience in healthcare technology and customer facing roles (required), • Proven ability to build deep, trust-based relationships with customer stakeholders, • Seasoned strategic program and project manager focused on connect the dots thinking that puts client value at the center of everything, • Skilled at expanding relationships beyond direct contacts through rapport-building, • Demonstrated ownership of complex, high-value customer accounts, • Strategic thinker who connects cross-customer trends to shape value propositions., • Effective and empathetic internal and external communication, • Previous experiencing working in one or more of the following areas (required):, • Experience working within RWD health analytic companies, CROs, or systems integrators in the healthcare sector, • Application of RWD and RWE in the pharmaceutical and life sciences space, • Understanding of drug development and/or clinical trials #LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is:$120,000—$150,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here. Know Your Rights, explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here. Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy.

Job Title: Clinical Supply Chain Planner Pay rate: $50/hr Job Overview The Clinical Supply Chain Planner is responsible for managing and overseeing end-to-end clinical supply chain activities for assigned clinical protocols. This role ensures the seamless supply of Clinical Trial Material (CTM) by collaborating with key stakeholders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Organizations (CMOs), and Contract Research Organizations (CROs). Key areas of responsibility include forecasting, packaging, labeling, distribution, inventory management, financial planning and budgeting, vendor oversight, and eTMF documentation. The ideal candidate will demonstrate strong attention to detail, excellent communication skills, and the ability to prioritize tasks in a dynamic, collaborative environment. Key Responsibilities • Manage packaging, labeling, and distribution of CTM for global clinical trials, • Support IRT (Interactive Response Technology) development, user acceptance testing (UAT), and system oversight, • Utilize and maintain internal budget forecasting and planning tools, • Partner with Clinical Operations to align on demand assumptions and trial requirements, • Develop supply strategies to maximize efficiency and minimize waste, • Design and manage supply and demand forecasts using web-based optimization tools, • Identify potential supply risks and implement mitigation plans, • Lead label creation and approval processes, including translations and regulatory compliance, • Communicate clinical supply requirements to Global Planning for coordinated execution, • Support return and destruction processes for CTM across assigned protocols, • Manage program and protocol budgets, monitor KPIs, and drive cost-saving initiatives, • Bachelor’s degree in Life Sciences or Supply Chain Management, • Minimum 3+ years of experience in clinical supply chain management, • Strong understanding of end-to-end clinical supply chain processes, • Experience with supply/demand forecasting systems (e.g., NSIDE, Bioclinica, 4G, Oracle), • Familiarity with IRT systems and their application in clinical trials, • Solid understanding of GxP compliance standards, • Proficient in Microsoft Office Suite (Excel, PowerPoint, Visio, Project), • Demonstrated adaptability and strategic thinking in response to external influences, • Exceptional attention to detail and organizational skills, • Excellent communication, collaboration, and influencing abilities, • Proven ability to manage multiple priorities and complex challenges

R&D Partners is seeking to hire a Senior Clinical Supply Chain Planner in Cambridge, MA. Your main responsibilities as a Senior Clinical Supply Chain Planner: · Managing packaging, labeling, and distribution of clinical trial material for global clinical trials · Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material. · Utilize and support the management and use of home-grown budget forecasting and planning tool · Partner with Clinical Operations to align on demand assumptions · Develop supply strategies to maximize supply efficiency and minimize waste What we are looking for in a Senior Clinical Supply Chain Planner: · BS degree in Life Sciences or Supply Chain Management · Experience: Minimum 3+ years of experience in clinical supply · Understanding of end to end clinical supply chain activity · Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc) · Experience with IRT systems Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO &, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval Pay Scale: $83,200 – $104,000 Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

Role: Regulatory Compliance Specialist Contract: ~6 months (potential for extension or early completion) Location: Remote (East Coast preferred) Start Date: ASAP We are looking for a Regulatory Compliance Specialist to support a Critical Quality Management System (QMS) initiative for investigational drug/device combination products for Johnson & Johnson You’ll play a key role in ensuring compliance with EU clinical trial regulations—particularly in Spain (AEMPS) and France (ANSM)—while helping streamline regulatory and quality processes across global teams. What You’ll Do • Operate independently while collaborating with Quality and Clinical Operations teams, • Evaluate and enhance the current QMS for EU clinical trial compliance, • Identify and close compliance gaps across procedures and documentation, • Support the development and simplification of SOPs and engineering documentation, • Provide expert guidance on EU country-specific regulations (Spain and France), • Lead or support cross-functional QMS initiatives What We’re Looking For • Proven experience in EU quality and regulatory compliance for investigational products, • Deep understanding of drug/device combination product regulations, • Experience building or amending QMS in large pharma settings, • Strong knowledge of AEMPS and ANSM requirements, • Ability to work independently and provide hands-on compliance expertise, • Experience supporting EU and US clinical trials

主要职责： 1. 撰写临床方案、临床研究总结报告及临床试验相关材料（包括 IND 或 NDA 中临床材料、伦理材料）；, 2. 审核临床试验相关文件，包括但不限于：CRF、数据统计分析计划、数据管理计划，药物安全报告管理 计划等，确保在临床试验的相关节点前完成；, 3. 在临床试验阶段，完成医学审核，及时发现研究中存在的问题并予以解决；, 4. 在开发总监带领下（如有），制定临床研发计划、完成临床研究设计；, 5. 解决临床试验中医学相关的问题以及分析相关数据，确保临床研究严格按照研究方案和 ICH-GCP，国家 相关法规、公司 SOP 进行；, 6. 负责与临床专家以及与国家药品评审部门沟通临床研究设计、开发策略等；, 7. 配合运营团队，对相关人员进行临床研究相关培训、项目启动医学支持等，以保证临床研究顺利开展。 任职资格： 教育背景： 临床医学专业硕士及以上学历相关经验： 博士学历不做要求； 语言要求： 英语水平至少达到 CET6 其他技能： 1. 熟悉药物研发进程；, 2. 熟悉《药品管理法》、《新药审批办法》、《药品注册管理办法》、ICH-GCP、临床试 验全过程、国内外临床研究发展与现状；, 3. 掌握电脑基础知识、熟练掌握办公自动化软 件的应用；, 4. 具有医生资格证。 能力要求： 1. 具有清晰的书面和口头表达能力，善于沟通；, 2. 具有优秀的跨职能团队协作能力；, 3. 能独立查阅有关文献资料，撰写各类报告；, 4. 具有独立工作能力，同时具有较强的集体意识和良好的团 队合作精神；, 5. 具有良好的问题解决能力和应急预案管理能力；, 6. 具有良好的适应能力，可以承受合理的任务压力；, 7. 时间观念强，能合理计划时间并在计划的时限内按时完成工作；, 8. 注重工作细节，对工作有耐心 Main Responsibilities: • Write clinical trial protocol, clinical study report and related materials in clinical study (e.g. the clinical part of IND and NDA, or ethical materials);, • Review clinical trial documents, such as Case Report Form (CRF), Statistical Analysis Plan (SAP), Data Management Plan (DMP) and Drug Safety Report Management Plan and so on. Make sure these documents are completed before the deadline;, • Review medical information, find and solve related medical problems timely during clinical trials;, • Make clinical development plan and complete clinical trial protocol design under the leadership of developing directors;, • Solve medical problems and analyse data related to medicine in clinical study. Make sure the clinical study conform to clinical trial protocol, ICH, GCP and company SOP;, • Communicate with clinical specialists and drug regulatory authorities on clinical study design and development strategies and so on;, • To protect clinical projects carried out successfully, you should cooperate with operation teams, train them to learn about the medical part of clinical study and provide medical support for clinical study project start up. Qualifications: Requirements: Education: Master's degree or above in Clinical Medicine Language Requirement: Professional working proficiency in English Other Skills: • Be familiar with drug research and development process;, • Be familiar with Drug Administration Law, New Drug Approval, Drug Registration Regulation, ICH, GCP, the whole process of clinical trial and the current status and development trend of the clinical trial at home and abroad;, • Master the basics of computer, and have good skills in office software. Requirements: • Strong written and oral presentation skills, good at communicating;, • Excellent collaboration in a cross functional team setting;, • The ability to independently consult relevant literature and write reports;, • The ability to work individually, the collective consciousness with strong team spirit;, • Strong problem-solving ability, good at managing emergency plan;, • Good adaptability with the ability to work under reasonable pressure;, • Have strong sense of time, manage time reasonably and complete the work on schedule;, • Pay attention to work details and be patient on work

The Senior Medical Director, Clinical Safety will provide strategic medical safety leadership for benefit-risk assessments of investigational products, with a particular focus on a key biologic asset in development for one of the company's leading products. Operating within a matrixed environment, this role oversees safety-related activities across the clinical development portfolio, including signal detection, risk evaluation, mitigation planning, and aggregate safety reporting. This position also leads the medical review of safety content in clinical documentation such as study protocols, investigator brochures, clinical study reports, product labeling, and regulatory responses. Additionally, the Senior Medical Director will manage a global team of pharmacovigilance professionals dedicated to clinical development safety activities. Key Responsibilities • Develop and maintain Development Risk Management Plans (DRMPs) to proactively minimize risks during clinical trials., • Collaborate with internal and external stakeholders to monitor safety profiles, validate and evaluate safety signals, and recommend appropriate risk mitigation strategies., • Lead the preparation and submission of aggregate safety reports (e.g., DSURs, PSURs, PBRERs)., • Own the development and maintenance of Risk Management Plans (RMPs)., • Provide expert input into safety sections of regulatory dossiers and contribute to responses to safety-related inquiries from health authorities and other stakeholders., • Participate in investigator and key opinion leader (KOL) meetings to address safety-related topics., • Oversee ongoing safety data review during clinical trials through structured Safety Plans and regular safety review meetings. Qualifications • M.D. required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance preferred., • Minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical organization., • At least 3-5 years of experience managing teams of safety physicians or scientists., • Deep understanding of international clinical development and post-marketing safety regulations, particularly for biologics., • Proven experience interacting with global health authorities on safety-related matters (e.g., RMPs, Clinical Overviews)., • Strong knowledge of global safety requirements across the product life cycle.

Company Description Community Resource Initiative leads the fight against HIV and other infectious diseases, providing access and support through drug assistance, insurance support, prevention, and research. As a unique public health nonprofit in Massachusetts, our goal is to make the state a healthier place for all residents. We offer a holistic, client-centered approach with a focus on social justice and healthcare equity. Our contributions to clinical research have been instrumental in the FDA approval of almost all currently available HIV medications. Role Description This is a part-time, hybrid role for a Clinical Research Coordinator based in Boston, MA. The role would be 3 days on-site, one day remote. The primary responsibility of an experienced Clinical Research Coordinator (CRC) is to lead the day-to-day operations of CRI’s clinical research studies in a professional and confidential manner, ensuring accurate and timely execution of protocols by overseeing patient recruitment, data collection, study compliance and regulatory framework and requirements while working closely with the Principal Investigator (PI) to achieve study objectives. The CRC is responsible for maintaining high standards of quality and ethics throughout the research process. This role requires a candidate experienced in phlebotomy (mandatory) and other basic patient care procedures (blood pressure, EKG) ensuring the safe and efficient execution of clinical trials. Successful applicants must have sufficient management skills to organize, supervise and carry out all aspects of clinical trials as well as the ability to work independently. They will have in-depth knowledge of protocol requirements and quality clinical practices as set forth by federal regulations. As the primary resource for protocols, the CRC is the liaison between Principal Investigator, Primary Care Providers, the Institutional Review Board, and Study Sponsors. With the Principal Investigator, the CRC will screen, enroll, and follow participants, ensuring protocol compliance and monitoring. They will also be responsible for all data and source documentation, adverse event reporting, and maintenance of regulatory files. The individual in this position is an integral part of the small but strong research team. The candidate should possess the experience and passion to understand and communicate the clinical research process and a strong interest in learning about cutting-edge therapies in development for treating people with HIV/AIDS. S/he must be able to work as part of a dynamic team, get along well with a variety of individuals and groups, possess a positive outlook, and demonstrate the ability to be flexible in situations. QUALIFICATIONS: EDUCATION: College degree can be substituted by 4 years of relevant research experience. EXPERIENCE: At least 5 years of experience as a Clinical Research Coordinator in a clinical setting. ACCOUNTABILITY: This position reports to the Study Investigator for all clinical issues and the Executive Director for all administrative issues. KEY RESPONSIBILITIES: • Study Start-up and Recruitment: Screening potential participants, obtaining informed consent, and developing recruitment strategies to meet enrollment goals., • Protocol Adherence: Ensuring all study procedures are conducted according to the established protocol, including data collection, monitoring adverse events, and timely reporting to the PI and sponsor., • Data Management: Accurately collecting, recording, and maintaining patient data in electronic case report forms (CRFs) and other study documentation., • Clinical Trial Management System (CTMS): Proficiency in using electronic platforms to manage study communication, data, track participant progress, and generate reports., • Laboratory Coordination: Coordinating with laboratory personnel to collect and process study samples, ensuring the vitally important laboratory requirements and proper specimen handling and analysis., • Regulatory Compliance: Adhering to all applicable regulatory guidelines (e.g., GCP, IRB) and ensuring study compliance with local and international standards., • Team Leadership and Training: Providing guidance, training, and mentorship to junior CRCs on study protocols and procedures., • Communication and Collaboration: Maintaining open communication with PI, Sponsor and other healthcare professionals involved., • Adverse Event Monitoring: Promptly identifying, reporting, and managing any adverse events experienced by study participants., • Study Closure Activities: Assisting with final data analysis, report generation, and archiving of study documents upon completion.

Industry: Pharmaceuticals Title: Senior Clinical Supply Chain Planner Job ID: CAMB000067 Location: Cambridge, MA (Hybrid) Duration: 06+ months contract (+Possibility of extension) Hybrid: Starting will be 3 days onsite Tues-Thurs ; once they are up to speed can be Tues and Weds. Job Overview The Clinical Supply Chain Planner is responsible for the management and oversight of end to end clinical supply chain activity for assigned clinical protocols. This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, support a collaborative environment with a strong communication skillset, and the ability to prioritize workload and meet project timelines. Summary of Key Responsibilities • Managing packaging, labeling, and distribution of clinical trial material for global clinical trials, • Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material., • Utilize and support the management and use of home-grown budget forecasting and planning tool, • Partner with Clinical Operations to align on demand assumptions, • Develop supply strategies to maximize supply efficiency and minimize waste, • Design and actively manage supply & demand forecasts in our web-based optimization tool, • Identify potential supply risks, and develop risk mitigation plans as necessary, • Drive label creation and approval process, including translations and regulatory requirements, • Communicate clinical supply requirements to Global Planning and ensure seamless coordination of demand and supply, • Support return and destruction of clinical trial material for assigned protocols, • Manage program and/or protocol budget, monitor Key Performance Indicators (KPIs), and strive to achieve relevant cost saving targets, • Maintain collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements Qualifications • BS degree in Life Sciences or Supply Chain Management, • Experience: Minimum 3+ years of experience in clinical supply, • Understanding of end to end clinical supply chain activity, • Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc), • Experience with IRT systems, • Strong understanding of GxP, • Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc), • Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics, • Strong attention to detail, • Excellent communication, collaboration, and influencing skills, • Ability to multi-task and manage complex challenges Additional Informations: Manager is seeking someone with min 3 years experience in clinical supply. Please target candidates with 3-7 years of experience. Not looking for someone who is sr manager or manager level. Ideal experience: Supply Demand forecasting IRT / UAT exp. and set up Working cross-functionally and Internal/Externally with clin ops or stability teams or CMOs Working with labels (IE: Experiences with booklets, global studies, translations, packaging, production requests ) Can work independently and hit the ground running High Performer Hybrid: Starting will be 3 days onsite Tues-Thurs ; once they are up to speed can be Tues and Weds.

W2 Contract Role - 6-12 Months Hybrid - Boston - On Site as needed (4 days per week likely on site) Local W2 Candidates only - 1-2 Years of Expreience - $30-$35/hr W2 • Work closely with research teams across the Department to ensure regulatory compliance and accurate data management collection, • The Regulatory Coordinator will work with investigators, staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements for clinical trials are met for Clinical Trials., • Complete feasibility questionnaires for upcoming studies, • Assist in start-up and implementation activities for new studies, • Completion and submission of clinical trials amendments to the IRB, • Maintenance of regulatory binders and other relevant files during the review, approval, and activation process for Clinical Trials Qualifications • Bachelor’s Degree required, • 2+ years of experience in a research setting performing similar project responsibilities

Extensive experience in acquisition, integration, and management of external clinical data, including laboratory data, pharmacokinetics (PK), ECG, biomarker, imaging, and wearable device data across global clinical trials. Deep understanding of data standards, harmonization, and validation for third

Job DescriptionAbout LILT AI is changing how the world communicates — and LILT is leading that transformation. We're on a mission to make the world's information accessible to everyone, regardless of the language they speak. We use cutting-edge AI, machine translation, and human-in-the-loop expertise to translate content faster, more accurately, and more cost-effectively without compromising on brand, voice, or quality. At LILT, we empower our teammates with leading tools, global collaboration, and growth opportunities to do their best work. Our company virtues—Work together, win together; Find a way or make one; Quicker than they expect; Quality is Job 1—guide everything we do. We are trusted by Intel Corporation, Canva, the United States Department of Defense, the United States Air Force, ASICS, and hundreds of global Enterprises. Backed by Sequoia, Intel Capital, and Redpoint, we’re building a category-defining company in a $50B+ global translation market being redefined by AI. The Production Team at LILT: LILT’s Production Team is a global workforce, operating across four continents. We are passionate about localization and making information accessible to all. The Team spans project management, program management, quality, and talent management, working with some of the world’s largest organizations. Working in LILT’s Production Team you will have access to leading tools, collaborative teammates, and opportunities to make a real impact. What You’ll Do: The Project Manager, Production ensures successful production execution across a portfolio of Life Science accounts. This role is a fundamental component of the production life cycle, ensuring projects are delivered on-time, on budget and to accepted quality standards. The Project Manager, Production will have customer facing production duties as well as internal responsibility to delegate project coordination and administrative work to teams of Production Coordinators. Key Responsibilities: * Able to complete project management tasks autonomously * Responsible for maintaining resources, core teams and pipeline to support project management work * Responsiveness to internal and external comms within pre-defined SLAs * Risk analysis to identify risks, potential issues, plan to and mitigate them * Able to define and delegate admin work to PCs Interns * Able to take responsibility for end to end project deliverables in accordance with SLAs * Effectively balances and manages priorities across a variety of task types and customers * Establishes deadlines /ensures deadlines are feasible and completes tasks by said deadlines * Escalates issues or problems to manager in an effective manner, along with proposed solutions * Asks pertinent questions to ensure full comprehension of the task in hand; Strictly follows Production SOPs and best practices. Responsible for CM, Quality and OTD KPIs. * Manage the end to end project management workflow * Ensure all projects are delivered on time as per customer SLA * Manage quality at project level - including Review, Verification, QA, LQE * Responds quickly and efficiently to internal and external stakeholders * Ensure all system admin, including data entry, is accurate * Process and approves invoicing and payments * Perform file analysis and engages with Solutions team for support on file types * Creates and monitors linguistic assets (TM, Style Guides, reference material) * Demonstrates a deep understanding of all production workflows and processes related to their accounts * Utilize systems and tools released by Production Enablement * Train supporting resources on key production processes and methodology * Develop and maintain process documentation related to their task load and the tasks delegated to other resources. * Consistently follow correct protocols for tasks and accounts. * Monitor and enforce adherence to correct production procedures * Provides insight to Strategist into revenue forecasts based on production volume * Manage quality complaints and feedback received from stakeholders * Raise Customer Support tickets for 100% of production blockers (Jira) * Identifies resource requirements for production work * Performs self-sourcing in our existing vendor database and enters sourcing requests when new vendors are needed * Completes ongoing risk assessment and mitigation for all production areas. * Manage linguist communication for all projects Skills and Experience: * A Bachelor’s degree, or equivalent; Master’s degree preferred * 2+ years of proven project management experience in clinical trials localization preferred * Excellent client-facing and internal communication skills * Solid organizational skills including meticulous attention to detail and multitasking skills * Able to meet deadlines and work under pressure Our Story Our founders, Spence and John met at Google working on Google Translate. As researchers at Stanford and Berkeley, they both worked on language technology to make information accessible to everyone. While together at Google, they were amazed to learn that Google Translate wasn’t used for enterprise products and services inside the company.The quality just wasn’t there. So they set out to build something better. LILT was born. LILT has been a machine learning company since its founding in 2015. At the time, machine translation didn’t meet the quality standard for enterprise translations, so LILT assembled a cutting-edge research team tasked with closing that gap. While meeting customer demand for translation services, LILT has prioritized investments in Large Language Models, human-in-the-loop systems, and now agentic AI. With AI innovation accelerating and enterprise demand growing, the next phase of LILT’s journey is just beginning. Our Tech What sets our platform apart: * Brand-aware AI that learns your voice, tone, and terminology to ensure every translation is accurate and consistent * Agentic AI workflows that automate the entire translation process from content ingestion to quality review to publishing * 100+ native integrations with systems like Adobe Experience Manager, Webflow, Salesforce, GitHub, and Google Drive to simplify content translation * Human-in-the-loop reviews via our global network of professional linguists, for high-impact content that requires expert review LILT in the News * Featured in The Software Report’s Top 100 Software Companies! * LILT makes it onto the Inc. 5000 List. * LILT’s continues to be an intellectual powerhouse, holding numerous patents that help power the most efficient and sophisticated AI and language models in the industry. * Check out all our news on our website. Information collected and processed as part of your application process, including any job applications you choose to submit, is subject to LILT's Privacy Policy at . At LILT, we are committed to a fair, inclusive, and transparent hiring process. As part of our recruitment efforts, we may use artificial intelligence (AI) and automated tools to assist in the evaluation of applications, including résumé screening, assessment scoring, and interview analysis. These tools are designed to support human decision-making and help us identify qualified candidates efficiently and objectively. All final hiring decisions are made by people. If you have any concerns, require accommodations, or would like to opt-out of the use of AI in our hiring process, please let us know at . LILT is an equal opportunity employer. We extend equal opportunity to all individuals without regard to an individual’s race, religion, color, national origin, ancestry, sex, sexual orientation, gender identity, age, physical or mental disability, medical condition, genetic characteristics, veteran or marital status, pregnancy, or any other classification protected by applicable local, state or federal laws. We are committed to the principles of fair employment and the elimination of all discriminatory practices. Compensation Range: $64K - $85K

Job Description The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention. In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners. The Alliance Foundation Trials (AFT) is looking for a Project Manager who manages the development, implementation, and oversight of assigned AFT studies. This role will also interact with pharmaceutical industry partners, vendors, investigative sites and physicians to help AFT studies from activation to closure. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer. Benefits of working at the Alliance for Clinical Trials in Oncology Foundation: • 8 weeks of paid time off (including PTO, sick, and holidays) during year one, • Medical, Dental & Vision plans with a 100% employer-paid option for employees, • Tuition reimbursement stipends, • Continuing Education, • 3% employer match for retirement investments, • Annual Employee Performance Bonus Program, • Annual Cost of Living Adjustment, • 50% commuter reimbursement, • Healthy Work/Life balance and flexibility ROLE & RESPONSIBILITIES • Acts as operations lead on one or more AFT studies, • Serves as primary point of contact between AFT and pharmaceutical industry partners associated with assigned AFT studies, • Assists with the design, planning, implementation, conduct, and management of clinical studies from initiation through completion, • Represents AFT Clinical Operations on the cross‐functional project team, and liaises with medical, statistical, regulatory, quality, and financial personnel, • Manages one or more AFT junior operations staff, • Oversees participating study vendors, including vendor agreements, statements of work, and vendor budgets, • Manages overall study budget, including approvals of all subject visit payments and vendor invoices for assigned studies, • Oversees and manages the development of study‐related documents together with the scientific team and protocol development team including, but not limited to, study protocol, informed consent forms, laboratory manuals, eTMF plans, etc., • Assists in the design, configuration, development, and oversight of study-level systems such as EDC, eTMF, and CTMS, • Organizes, schedules, and leads study teleconferences and in-person meetings with investigative sites, physicians, vendors, and consultants as needed, • Serves as the central escalation point for all study issues originating with component groups such as data management, site management, site monitoring, laboratory management, etc., and tracks escalated issues through to resolution, • Reviews study-related materials including, but not limited to, monitoring reports, key performance metric reports, clinical trial agreements, etc. as needed, • Works with the AFT Regulatory Manager to support regulatory filings as needed, • Initiates and maintains study protocol(s) and associated amendment tracking, • Oversees site activities on assigned studies, including feasibility, activation, accrual, maintenance, and closure, • Tracks study progress and manages clinical timelines, including regulatory document collection, IRB approval, enrollment, management of clinical supplies, etc., • Helps build and maintain relationships with site investigators and other site study staff, • Assists with the reporting of clinical data for regulatory or medical scientific purposes, including study publications, • Participates in the development and implementation of SOPs and Clinical Operations processes and systems QUALIFICATIONS AND EDUCATION • A minimum of a BA/BS degree is required, • 4‐6 years of Pharmaceutical, Academic Research Organization, or Clinical Research Organization research and project management experience required, • Willingness and capability to handle multiple studies and responsibilities with shifting priorities, • Demonstrated project management skills; meeting project timelines and budgets, • Prior experience assisting in the design, planning, and implementation of a study from initiation through completion, • Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations, • Excellent organizational, leadership, and problem‐solving skills, • Excellent written and verbal communication skills, • Ability to successfully work both within a team and independently, • Experience working in EDC (RAVE preferred), eTMF, and CTMS systems, • Proficiency in Microsoft Office applications, • Ability to travel several times a year., • Must be authorized to work in the U.S. PREFERRED SKILLS • Degree in a health or science major preferred., • Experience working in oncology research preferred The estimated base salary for this position is $92,500 - $105,000. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based on other factors such as relevant skills, experience, and location. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all duties and responsibilities associated with it.