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Job Description Company Overview: Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn's inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn's AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn. Position Overview: The Director, Supply Chain will focus on ensuring continuous supply for Avalyn's clinical trial materials, including drug–device combination products used across Avalyn's inhaled therapy portfolio. This leader will collaborate cross-functionally with Clinical, Quality, Regulatory, and Project Management, as well as Contract Manufacturing Organizations (CMOs) and device manufacturers globally to accomplish project objectives and timelines. The role includes developing strategies for labeling, packaging, and distribution of study drug and associated devices, overseeing global inventory, and ensuring regulatory compliance across multiple regions. The Director will play a key role in planning and managing clinical supply activities required for Phase 1–4 studies worldwide. This position will also be responsible for hands-on monitoring and tracking inventory levels, identifying potential supply chain issues and providing feedback and recommendations to the appropriate resources regarding demand, expiry and resupply of products. This position will report to SVP, Product Development. Key Responsibilities: · Develop and implement strategies for manufacturing, labeling, packaging, device handling, distribution, and return of clinical trial materials (CTMs), including drug–device combination products, to support early- to late-stage clinical trials. · Manage end-to-end global supply logistics, including international shipment planning, temperature-controlled distribution, and regional customs/export requirements. · Develop forecasts for clinical packaging, labeling, and distribution activities. Create and maintain global CTM inventory at multiple depots to ensure uninterrupted supply across US, EU, and rest-of-world clinical sites. Develop RFPs and manage clinical supply packaging/labeling contract with vendors · Partner with Clinical Operations, Quality, Regulatory and Project Management to ensure timely delivery of CTM to clinical sites in compliance with global regulatory requirements. · Select CTM labeling and packaging vendors and participate in vendor audits, as applicable. · Maintain CTM inventory at multiple study depots to ensure sufficient inventory at clinical sites. · Work closely with the Finance Department to ensure the cost and movement of CTMs are accurately reported, providing finance with reports of monthly activity and ending balances. · Procure comparator or commercial products as needed to support clinical trials. · Direct and provide oversight to CTM packaging and labeling activities at vendors and distribution of clinical supplies to depots and clinical sites. · Provide operational and financial planning and maintenance of clinical supplies. · Serve as the primary point of contact for all CTM supply chain activities, internally and externally to clinical supply chain vendors and contractors. · Review clinical trial documents, such as investigator brochures and clinical study protocols to understand impact on supply and to strategically design supply plans to ensure continuous support for clinical trials. · Coordinate review of packaging/labeling batch records and other quality-related documentations for release of study drug and devices. · Manage package and label development/approval process and distribution timelines. · Act as the unblinded contact for Avalyn Pharma on all blinded studies. · Oversee the return of malfunctioned devices and defective products to manufacturer for analysis and replacement. · Participate in the development and implementation of IRT systems to support global trials and ensure accurate tracking of drug-device supplies. · Promotes a feedback culture and constantly improving their own and their teams' skills through lessons-learned reviews at project completion. · May manage, coach, and mentor direct reports. Key requirements for this role are: · Bachelor's degree in life sciences, supply chain management, engineering, or business major · 10+ years of pharmaceutical industry experience in clinical supply chain management, including direct experience supporting combination drug–device products or inhaled delivery systems (respiratory product development strongly preferred). · Certification in Supply Chain Management (APICS CIPM/CSCP) preferred · Proven past experiences in supply chain leadership role with a strong track record of achievement through pivotal trials · Direct experience in launching CTMs for a large global clinical study is desirable · Demonstrated experience managing global clinical supply chains, including labeling, packaging, distribution, and CMO/third-party vendor oversight across North America, EU, and other international regions. · Hands-on experience managing clinical supplies for multiple, parallel trials and navigating global regulatory requirements (e.g., EU Annex 13, FDA, MHRA). · Strong understanding of clinical protocols and study designs, and hands-on experience implementing IRT systems for global trials. · Thorough understanding of global regulatory requirements related to labeling, packaging, and distribution of drug-device CTMs · Self-motivated, independent, and able to work effectively in a small team and fast-paced environment who understands the need for growth and is receptive to constructive feedback · Domestic and international travel is required to visit and audit vendors, attend training, and conferences (up to 10%) · To ensure that the highest level of services is provided, additional duties may be assigned, and evening, weekend and holiday work may be required Proposed pay range$200,000—$230,000 USD

Job DescriptionJob Description Role Summary We are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical trials. In this key role, you will partner closely with the Clinical Operations Study Lead to manage critical components of study delivery—ensuring timelines, quality standards, and budget expectations are met. You will drive meeting coordination, site and vendor support, documentation management, and quality oversight across assigned studies. This position offers the opportunity to make a meaningful impact on study execution while working with minimal oversight. Key Responsibilities Study Team & Meeting Management (50%) • Lead preparation of agendas and meeting minutes for cross-functional study team meetings, • Support site start-up activities, • Manage ancillary vendors as assigned, • Monitor systems, processes, and vendors to ensure clinical trial data quality; identify risks and recommend improvements, • Review clinical protocols for operational feasibility and anticipate potential study delivery challenges, • Draft and maintain clinical project timelines; proactively escalate risks to the Study Lead, • Support clinical trial budget analysis and cost tracking, • Track 1572s and collaborate with Regulatory for IND submissions and essential documents, • Maintain and QC Trial Master File (TMF) documents, • Assist with creation and distribution of ICF templates, manuals, and other study materials, • Contribute to the review of core study documents (protocol, IB, CSR), • Manage sample accountability and tracking, • Develop, maintain, and QC study documentation and trackers, • Perform additional operational activities as assignedQualifications Required Qualifications • Bachelor’s or Master’s degree with 3+ years of clinical operations experience in pharma or CRO, • Strong understanding of ICH, GCP, and global regulatory expectations, • Ability to interpret and communicate protocol requirements, • Advanced proficiency with clinical trial software platforms, vendor systems, and related tools, • Understanding of data-technology interdependencies, vendor metrics, and operational nuances across vendor types, • Excellent verbal, written, and presentation skills Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $116,800 - $160,600. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: • Competitive salary and annual bonus., • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more., • Generous parental leave and family planning benefits. Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Job Description The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Global MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's gene therapy products. JOB RESPONSIBILITIES: • Lead all aspects of process technology transfer from early and late-stage process development for clinical and commercial manufacturing., • Provide technical support to manufacturing and write product impact assessments to support deviations., • Provide input on scope of work proposals to ensure clients' goals are met., • Cross functionally collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed, • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues., • Runs client facing meetings regarding technical topics and scope of work progress, • Ability to provide impact assessments and aid in root-cause analysis for critical deviations and determine CAPAs for manufacturing., • Author technical documentation: Protocols, and reports., • Reviews executable documents: Batch records, SOPs,, • Assist process validation studies to develop a thorough understanding of operating and performance parameters., • Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner, • Experience with customer facing discussions EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired Bachelor's Degree in Engineering or other related scientific discipline. Essential Master's Degree in Engineering or other related scientific discipline. Desired ON-THE-JOB EXPERIENCE 6+ (BS) or 4+ (MS) or 0-2 (PhD) years of relevant experience in gene therapy or other biotechnology industry. Essential SKILLS / ABILITIES Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing. Essential Good understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics. Essential Ability to present to and interact with clients on behalf of the MSAT team Essential Experience developing and executing tech transfer into GMP manufacturing. Essential Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner Essential Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis) Essential Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal. Essential Proven knowledge and experience of risk-based approaches to process development and validation. Essential Demonstrated sufficient knowledge and experience in cell culture and cell & virus banking. Essential Ability to cope with many topics in parallel, to cope with strict timelines and to handle pressure. Essential Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Essential Knowledge of the current pharmaceutical, regulatory, and technology trends. Desired Knowledge of data management tools and statistical process controls. Desired PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms, • Frequently lift and/or move up to 10 pounds GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS • Paid vacation days, amount based on tenure, • Paid sick time, • 10 observed holidays + 2 floating holiday + 1 volunteer day, • 401(k) plan with company match up to 6% of salary, vested immediately, • Share Appreciation Rights, • Choice of several healthcare plans, • FSA and HSA programs, • Dental & vision care, • Employer-paid basic term life/personal accident insurance, • Voluntary disability, universal life/personal accident insurance, • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time., • This position requires a criminal background check., • Genezen is an Equal Opportunity Employer., • Genezen participates in EVerify. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

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: In this role, you will lead statistical aspects of clinical development projects and ensure statistical strategies and methodologies align with clinical development objectives and regulatory expectations. This critical role requires strong statistical and cross-functional leadership to influence clinical development and decision-making to support company’s goals. You will work collaboratively with multiple functions, such as medical, clinical science, clinical operations, clinical pharmacology, translational medicine, pharmacovigilance, regulatory affairs, and data management to plan, execute and interpret statistical analyses to ensure analysis integrity and quality, in compliance with regulatory standards. Your Role: • Lead and execute statistical strategies for one or more clinical studies, including contribution to study design, statistical analysis, study results interpretation, clinical study report, database lock, regulatorysubmissionsand publications, • Accountable for timeliness, quality, integrity and consistency of study and submission level statistical deliverables on assigned projects, • Provide statistical input for cross-functional activities, collaborate with other functions to make progress on projects, and provide insights and leadership to influence decision-making, • Lead or contribute to studyand regulatorydocuments such as study protocols, statistical analysis plans, mockup shells, endpoint assessment charters,Case Report Forms (CRFs),Investigational New Drug (IND) applications, and New Drug Applications (NDAs), • Plan, perform andvalidatestatistical analyses of clinical trial data using SAS or Rin accordance withregulatory and internal standards, • Contribute to study design, including performing simulations to assess operating characteristics and optimize design parameters, • Apply advanced and innovative statistical methods to support business needs, • Design and execute exploratory data analyses to assess data trends,formand test hypotheses, and generate new insights from clinical trial data, • Manage and oversee statistical and programmingClinical Research Organizations (CROs)and vendors to ensure high-quality andtimelydeliverables, • Contribute to department processes,SOPsand initiatives, • Maintain awareness of industry standards, trends, and regulatory requirements Required: • APhD in Statistics, Mathematics, orarelated field witha minimum of eightyears of industry experience in clinical trials, oraMaster’s Degreein asimilar disciplinewith at least ten years ofindustry experience in clinical trials, including experience in oncology drug developmentfromPhase 1/2 to Phase 3, • Demonstrated technical knowledge of statisticalmethodologyand proven ability to appropriately apply it in trial design,analysisand result interpretation to support clinical development, including experience working with SDTM,ADaM,eSUB, and CDISC requirements, • Strong hands-on skills in statistical analyses,modelingand trial simulation, includingproficiencyin programing languages such as SAS and R, as well as experience with external control and biomarker analyses, • Experience with regulatory submissions including NDAs or BLAs, • Experience with data science and/or machine learning C4 Therapeutics is an Equal Opportunity Employer.

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 Position: Associate HR Business Partner Salary Range: $80,000 - $95,000 Location: Woburn, Boston, MA About Pharmaron Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: We are seeking a dynamic and experienced Associate HR Business Partner to join our team. As a HRBP, you will play a pivotal role in ensuring the efficient and effective operation of our Human Resources activities, contributing to the success and growth of our organization. Key Responsibilities: • Drive HR program success by providing consultative support and coaching to business colleagues in various HR areas, with a focus on achieving desired outcomes., • Collaborate with business and HR teams to strategically execute key initiatives such as recruitment, performance management, workforce planning, and employee development, enhancing organizational structure and performance., • Develop, administer, and ensure compliance with HR programs and policies, including hiring, onboarding, engagement, performance management, compensation, benefits, and records management, while continuously striving for process efficiency., • Promote the value of HR programs by effectively communicating their business impact and facilitating smooth implementation to minimize disruption., • Work alongside business leaders and HR teams to enhance employee engagement, address employee relations issues, and foster a positive organizational culture., • Support employee training and development efforts, contributing to continuous learning and growth within the organization., • Stay updated on HR-related training and industry best practices to enhance expertise and contribute to HR excellence., • 3+ years of well-rounded HR Generalist experience., • Experience with HR technology and use of HR Information Systems (HRIS)., • Strong understanding of HR practices, policies, and regulations., • Knowledge of federal, state, and local employment laws and regulations., • Ability to manage projects/processes, working independently with limited supervision., • Ability to identify and navigate issues/problems that are difficult and sometimes complex., • Excellent verbal and written communication skills., • Strong organizational skills and attention to detail., • Excellent time management skills with a proven ability to meet deadlines. Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance, • 401k plan with generous employer match, • Access to an Employee Assistance Program How to Apply: Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-NV1

Job DescriptionCompany Description Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide. Zai Lab’s global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it’s needed most. Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors. In China, we’ve earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine. Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth. Job Description The Medical Director will support the clinical development of oncology programs, focusing on the design, execution, and oversight of clinical trials. Responsibilities include independently contributing to and executing on the clinical strategy, serving as Medical Monitor, supporting regulatory submissions, and collaborating and leading cross-functional teams. The role provides scientific and medical input to ensure the successful conduct of clinical trials and advancement of oncology assets. This role reports to the VP, Clinical Development, Oncology and is based in our Cambridge, MA office. • Clinical Trial: Provide medical expertise to support the leading physician/scientist for the design and execution of oncology clinical trials. Collaborate with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements., • Medical Monitoring: Serve as Medical Monitor for assigned clinical trials, ensuring patient safety, protocol compliance, and medical oversight. Review safety data, participate in data monitoring activities, and act as the primary medical contact for study teams and investigators., • Cross-functional Collaboration: Work with regulatory affairs, clinical operations, pharmacovigilance, biostatistics. medical affairs, and commercial teams to align clinical and business objectives, often across multiple time zones., • External Representation: Represent Zai Lab in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators., • Data Analysis & Interpretation: Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Collaborate with cross-functional teams to translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement., • Regulatory Support: Support the preparation of regulatory documents, participate in health authority interactions, and contribute to risk management planning and mitigation strategies throughout the development lifecycle., • Business Development Support: Support medical leadership team to to support licensing opportunities, partnerships, and due diligence activities., • Scientific Support: Maintain up-to-date knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy and contribute to clinical development function.Qualifications REQUIRED • Clinical development experience, with a focus on late-stage trials, preferably as a Medical Monitor, • Experience in cross-functional team environments, • Understanding of oncology drug development, clinical endpoints, and regulatory pathways., • Clinical practice experience or experience as an investigator, • Strong communication skills., • Effective collaboration skills to effectively interact with internal and external stakeholders., • High ethical standards and commitment to scientific rigor. Additional Information The pay range for this position at commencement of employment is expected to be between $257K and $299K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai Lab, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life,” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Description • Lead operations across clinical sites to meet trial objectives., • Develop strategy and methodology for clinical operations programs., • Ensure clinical trials comply with regulatory requirements and are inspection-ready., • Plan, oversee, and deliver clinical programs from development to proof of concept., • Manage budgets and timelines in accordance with regional regulations and ICH-GCP guidelines., • Provide operational and strategic input on training materials and development plans., • Oversee vendor selection and ensure effective vendor management., • Identify and manage risks to ensure high-quality trial delivery., • Ensure investigational product oversight and document management., • Lead patient recruitment efforts and ensure safety compliance.

Description The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development at Alkermes. He/She will lead operations across all future clinical sites to ensure operational and the organization’s objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance. Role and Responsibilities • Responsible for developing strategy, and methodology of clinical operations programs., • Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready., • Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals., • Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines., • Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers)., • Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols., • Responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable., • Drive site selection and subject recruitment programs to deliver study enrollment targets., • Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors., • Participates in SOP development, process mapping, training of CTAs, and other departmental activities., • Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs Minimum Education & Experience Requirements: • M.S or Ph.D in basic sciences with 10+ years’ experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO., • Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality., • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required., • Experience leading global trials outside the US/UE/ASIA/Americas is preferred., • Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management., • Demonstrated experience in successful planning and implementation of clinical trial operations., • Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance., • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Required / Desired • 5+ years of experience in clinical trials

ICON is seeking Senior Global Clinical Trial Manager for the Waltham, MA office. Pay up to $170k (No bonus) As the Senior Global Clinical Trial Manager, will be responsible for Running global clinical trials, trial deliverable, trial budget, trial vendors, CRA and Site operational oversite and training. Following monitoring plans and reviewing trip reports. This position will be, direct hire with full benefits, 3 days in the office (900 Winter St, Waltham, MA 02451) with 2 days remote from home, with pay up to $170k (No bonus) Please let me know if you are interested in finding out more about this opportunity? Senior Global Clinical Trial Manager (ICON embedded with Alkermes) What you will be doing: • Clinical Trial Management with, deliverable, budget, vendor management, along with vendor and site oversite and training., • Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation., • Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight., • Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance., • Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines., • Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary., • Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Your profile: • Currently, or recently, working at a CRO, Pharmaceutical or Biotechnology company., • A minimum of 4+ years of experience in a Global Clinical Trial Management position at a CRO or Pharmaceutical Organization., • Clinical Trial Management experience including trial deliverable, trial budget, vendor management, along with vendor and site oversite and training., • Experience as a Clinical Trial Manager running Phase 1 trials, • Bachelor's degree in health, life sciences, or other relevant fields of study., • At least 10+ years of relevant clinical experience, • Preferred: 2+ years of monitoring experience., • Experience in managing complex or global trials is advantageous., • Experience in managing trial components from start-up to database lock., • Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives.

Director of Data and Biostatistics Education and Experience: · Master’s degree in Life Sciences, Health Informatics, Biostatistics or related field. · Minimum of 8–10 years of data management and/or biostatistics experience in clinical research, with at least 3 years in a leadership role. · Strong background in medical device clinical trials and understanding of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155). · Knowledgeable in statistical methods. · Proficiency with clinical data systems (e.g., Medidata Rave, Oracle InForm, REDCap). · Experience with device data integration and analysis. · Solid understanding of database design, data standards (e.g., CDISC), and data quality assurance. · Excellent communication, leadership, and project management skills. Skills/Competencies: · Excellent written and effective verbal communication skills. · Ability to communicate cross-functionally across the organization. · PC skills; word processing, spreadsheet, database, Internet search and utilization. · Flexible and able to work in a fast-paced environment. · Team player. · Ability to organize and judge priorities. · Excellent ability to generate and maintain accurate records.

We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities. What you will be doing: • Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation., • Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight., • Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance., • Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines., • Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary., • Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Your profile: • A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization., • Bachelor's degree in health, life sciences, or other relevant fields of study., • Phase 1 experience preferred, • At least 10+ years of relevant experience in clinical trial management., • Preferred: 2+ years of monitoring experience., • Experience in managing complex or global trials is advantageous., • Preferred: Experience in managing all trial components from start-up to database lock., • Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives., • Fluency in English (reading, writing, speaking).

A leading organization is currently seeking a skilled Clinical Trial Specialist for a Remote contract opportunity. This role is pivotal in ensuring the successful execution of clinical trials from start-up through closeout. Responsibilities: • Actively involved in the performance of study feasibility assessments, • Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms), • Manage the collection, review and approval of regulatory documents from clinical sites, • Coordinate investigational product release activities across clinical sites, • Manage and track study specific payments, • Create study-specific site budgets, • Initiate, maintain and reconcile the Trial Master File, • Assist in the preparation of Investigator and Study Coordinator Meetings, • Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs, • Coordinate communication of tracking information within the study team and to the clinical sites, • Develop and review Standard Operating Procedures, • Perform other duties, as needed Qualifications: • Bachelor's Degree, • Previous experience in Clinical Trial Coordination and/or Site Management, • Understanding of Study Phases and general knowledge of how they apply to Clinical Development, • Working knowledge of ICH Good Clinical Practice guidelines, • Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). The Director will be a leader in the organization who knows how to manage a team internally, at our clinical sites, and with our vendors. • Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards, • Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies, • Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones, • Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program, • Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards, • Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct, • Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity, • Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports, • Hire, train and develop the Clinical Operations program team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence Skills and experience you’ll bring: • BA/BS, preferably in a health-related field, • 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry, • Prior experience building and leading a high-performing clinical operations team, • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GCP, • Ability to manage multiple competing priorities and adapt to changes in a high-pressure environment, • Strong communication, interpersonal, and problem solving skills, • Must be comfortable working in a fast-paced environment

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 Care Access is seeking an experienced and strategic Manager, Study Training Compliance and DOA Management to lead a high-performing team within the Central Support Operations unit, part of the Global Expansion and Study Operations department. This role is responsible for overseeing the development, execution, and continuous improvement of study training compliance and Delegation of Authority (DOA) matrix management processes across the organization's clinical research portfolio. The Manager ensures all activities align with regulatory standards, sponsor expectations, and internal quality systems, contributing to overall site and study readiness. As a departmental leader, this individual will supervise a team of specialists and senior specialists, manage workload prioritization, support audit preparedness, and drive operational excellence through strategic collaboration and cross-functional partnership. The ideal candidate brings deep clinical research experience, a proactive mindset, and a strong track record in managing documentation-driven compliance operations in regulated environments. How You'll Make An Impact • Team Leadership & Oversight, • Supervise, mentor, and develop a team of specialists and senior specialists supporting study training compliance and DOA matrix functions., • Manage daily team operations including task delegation, performance tracking, workload balancing, and professional development support., • Establish team goals, timelines, and KPIs aligned with departmental and organizational priorities., • Ensure team adherence to SOPs, training protocols, and documentation standards., • Training Compliance Strategy & Oversight, • Oversee organization-wide monitoring of clinical staff training completion for both study-specific and mandatory compliance training., • Ensure standardization of training tracking workflows, documentation accuracy, and timely resolution of gaps across trials., • Collaborate with internal clinical education team, compliance, and operations teams to align on training expectations and rollout strategies., • Delegation of Authority (DOA) Matrix Management, • Own the process for DOA matrix setup, maintenance, review, and investigator approvals across trials., • Ensure delegation alignment with role-based training completion, protocol requirements, and site activation timelines., • Serve as a subject matter expert on DOA matrix processes during audits, inspections, and sponsor inquiries., • Audit & Inspection Readiness, • Partner with Clinical Operations, Quality, Clinical Education, and other internal stakeholders to ensure training and delegation matrix readiness across study lifecycles., • Support site-staff and study start-up readiness by contributing to training plans, documentation checklists, and process guidance., • Represent the function in planning meetings, trial kick-offs, and sponsor-facing communications when required., • Develop and refine audit preparedness strategies across Central Support Operations., • Process Optimization & Strategic Projects, • Identify gaps, inefficiencies, and risks in current workflows; lead improvement initiatives to increase compliance, efficiency, and documentation integrity., • Contribute to the development and refinement of SOPs, Work Instructions, system design, and quality tools to support scale and consistency across programs., • Monitor performance metrics and provide insights to leadership to support continuous improvement., • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required, • Deep understanding of clinical research operations, GCP compliance, and site readiness requirements., • Strong leadership and team development skills, with the ability to guide staff through complex compliance and operational workflows., • Advanced skills in documentation management, audit preparation, and protocol compliance tracking., • Proficiency with systems such as Florence (eISF), Clinical Conductor (CTMS), and sponsor-facing training platforms., • Excellent interpersonal and communication skills, including the ability to interact professionally with clinical teams, sponsors, and leadership., • Strong analytical and organizational abilities with attention to documentation accuracy, timelines, and regulatory requirements., • Proficient in Microsoft Office Suite and collaborative tools (Excel, SharePoint, Outlook, etc.). Certifications/Licenses, Education, and Experience:, • Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field required; Master's degree or certification (e.g., ACRP, SOCRA) preferred., • Minimum of 5+ years of experience in clinical research or regulatory compliance, including at least 2 years in a team lead or management role., • Demonstrated success in managing training compliance, DOA matrix workflows, and documentation oversight within a regulated clinical trial environment., • Experience supporting audits, inspection readiness, and cross-functional collaboration in a multi-study organization. How We Work Together, • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment., • Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role., • 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:

Clinical Trial Manager – Phase 1 Studies Location: Hybrid (3 days/week onsite in Waltham, MA) Contract Role Overview Our client's Early Clinical Stage Development team is seeking an experienced Clinical Trial Manager (CTM) to lead Phase 1 clinical trial operations. This role plays a central part in advancing early-stage clinical programs and ensuring high-quality, inspection-ready execution across all clinical sites. The CTM will provide end-to-end operational leadership, including strategy development, trial planning, vendor oversight, budget management, and proactive risk mitigation to ensure on-time, compliant delivery of Phase 1 studies. Key Responsibilities Develop and implement strategy, methodology, and operational plans for clinical programs. Ensure all clinical trials are conducted in full compliance with regulatory requirements and are consistently inspection-ready. Lead the planning, oversight, and execution of Phase 1 studies—from Start of Development through Proof of Clinical Concept. Manage trial budgets, timelines, and operational deliverables in accordance with ICH-GCP and applicable global regulations. Provide operational and strategic input on training materials, program standards, clinical development plans, and regulatory documents (e.g., Investigator Brochure, CSR, safety updates, briefing books, submission content). Drive execution excellence and contribute to trial protocols, asset evidence plans, and other development documents. Collaborate with the Clinical Trial Supply Unit to determine comparator sourcing strategies as needed. Lead site selection, startup activities, and recruitment strategies to meet enrollment goals. Participate in database setup, UAT testing, and development of monitoring guidelines, edit checks, and data cleaning workflows. Support departmental activities including SOP development, process mapping, and training of Clinical Trial Assistants. Serve as a key liaison with global cross-functional stakeholders including project management, regulatory affairs, and technical function leads. Minimum Qualifications M.S. or Ph.D. in a scientific discipline with 10+ years of Clinical Operations experience in biotech, pharma, or CRO environments. Strong ability to identify and champion process improvements focused on efficiency, reliability, cost, and quality. In-depth knowledge of FDA/EMEA regulations, ICH guidelines, and GCP requirements. Experience leading global clinical trials; international trial oversight experience preferred. Advanced expertise in patient recruitment, compliance management, safety oversight, document control, investigational product management, and budget administration. Demonstrated success in planning and executing clinical trial operations across all phases. Experience developing protocols, SOPs, CSRs, and regulatory-supporting documentation for NDAs. Proven track record of driving business process transformation and leading cross-functional teams toward complex deliverables.

Description The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development at Alkermes. He/She will lead operations across all future clinical sites to ensure operational and the organization’s objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance. Role and Responsibilities • Responsible for developing strategy, and methodology of clinical operations programs., • Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready., • Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals., • Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines., • Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers)., • Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols., • Responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable., • Drive site selection and subject recruitment programs to deliver study enrollment targets., • Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors., • Participates in SOP development, process mapping, training of CTAs, and other departmental activities., • Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs Minimum Education & Experience Requirements: • M.S or Ph.D in basic sciences with 10+ years’ experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO., • Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality., • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required., • Experience leading global trials outside the US/UE/ASIA/Americas is preferred., • Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management., • Demonstrated experience in successful planning and implementation of clinical trial operations., • Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance., • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Required / Desired • 5+ years of experience in clinical trials

Associate Director, Clinical Operations Base Salary: $145K-$215K USD + Bonus | Full-Time | Remote A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting-edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune-mediated conditions. Be part of a team where innovation meets purpose-and help shape the next generation of therapies. Key Responsibilities • Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications., • Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards., • Own budgets, timelines, and risk mitigation plans for all clinical programs., • Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality teams., • Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role., • Proven track record managing global trials and CROs., • Strong knowledge of GCP, ICH, and regulatory requirements., • Immunology or inflammatory disorder experience preferred. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

Phase I vaccine experience preferred fast paced studies 10 site visits a month • The Senior CRA will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements., • Responsibilities:, • Applies knowledge of ICON’s policies and procedures, • Demonstrates excellent written and oral communication, • Demonstrates excellent knowledge of ICH/GCP, • Displays ability to manage investigative sites to facilitate trial deliverables, • Demonstrates ability to escalate issues appropriately, • Conducts monitoring to confirm subject safety and data integrity, • Describes and demonstrates the principals of IP accountability, • Identifies scientific misconduct at the site level, • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms, • Mentors CRAs new to the position or company, • Serves as an observation visit leader, • Conducts monitoring evaluation visits, • Assists team lead in the development of trial tools or documents, • Assists with CTM tasks, • Participates in the development of process changes/improvements, • Presents at client meetings/Investigator meetings, • Provides training to trial teams At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

A recognized pharmaceutical company is actively seeking a new Quality Assurance (QA) Specialist to ensure data integrity and system compliance across clinical systems and cloud technologies. Responsibilities: • Develop, document, and execute test plans, scenarios, and test cases for clinical trial applications and data workflows, • Perform functional, regression, and integration testing to validate new features and ensure existing functionality remains intact, • Utilize QTest for test management and documentation, • Conduct defect management, including logging, tracking, and verifying fixes, • Collaborate with development teams in an Agile environment to ensure timely and accurate testing, • Identify and resolve data quality issues at the business level, ensuring compliance with regulatory standards, • 5+ years of QA experience in the Clinical Trials / Pharma domain, • Strong knowledge of AWS, Databricks, and clinical systems (CTMS, EDC, eTMF), • Proficiency in QTest for test case management, • Experience with SQL and Athena for data validation, • Experience with Python (ability to read and understand code), • Microsoft Excel (pivot tables, linked spreadsheets), • Familiarity with Jira for issue tracking and Agile workflows, • Solid understanding of Clinical Data standards (CDISC, SDTM), • Knowledge of GxP Compliance and Regulatory requirements

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We're looking for our next Staff Technical Program Manager, an experienced scrum master who knows how to shepherd a product portfolio through the full product realization cycle while navigating competing priorities for a regulated product. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities You'll help to lead the development team from planning through verification and validation to produce the best possible solution in a compliant, high-quality, and timely manner. You'll have strong experience in risk management and delivering products in a regulated environment, such as software as a medical device (SaMD). On any given day you could be doing any of the following: • Communicating and coordinating activities across the product, engineering, AI, regulatory, quality, and external partnership teams., • Developing and maintaining SOPs, work instructions, and other process documentation for the team and ensuring team alignment and compliance, • Leading risk analysis activities in accordance with ISO 14971 and IEC 62304, • Tracing requirements to product architecture, system design and verification/validation test cases for compliance and regulatory needs, • Coordinating with AI scientists, engineers, and product managers to develop documentation to support regulatory submissions, • Running agile ceremonies and orchestrating sprint and project milestones in coordination with Product Management, • Ensuring that engineers have all of the information, requirements, acceptance criteria, and designs they need to implement and deliver new features and functionality effectively and efficiently, • Coordinating with engineering managers and product managers on release planning activities, timelines, and documentation., • Providing executive-level reporting on program status, risks, and critical path items to leadership and external partners., • Leading bug triage and prioritization with the team Requirements • 8+ years of technical program manager experience, or an equal combination of relevant experience in related disciplines, • BS in Engineering preferred or other relevant field with prior experience, • Certified scrum master with demonstrated experience facilitating agile processes, • Excellent verbal and written communication skills, • Demonstrated work history maintaining product documentation & versioning within a Quality Management System, • Ability to engage technical and non-technical audiences via strong written, verbal, and visual communication skills, • Proven ability to build relationships, collaborate, and influence internal teams and partners, • Strong analytical and problem solving skills, • Capability to succeed in a fast-paced environment with shifting priorities, and manage projects with competing priorities and timelines, • Previous experience working daily with data scientists, engineers, product managers, regulatory and quality team, and clinicians in a digital health environment, • Previous experience working in a start-up environment with a highly collaborative culture, wearing multiple hats as needed and "pitching in" as necessary, • Experience working in a highly regulated medical device environment with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45 standards and regulations TTC*: $224,250.00 - $258,750.00 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Shift: Monday through Friday, 8:00 AM - 4:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. SUMMARY Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions. NOTE: This is an EVERGREEN posting where we are collecting candidates for a future role Compensation: $35.00 - 50.00 per hour ESSENTIAL FUNCTIONS • Serves as a lead to staff to include providing work direction, guidance, and training., • Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information., • Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing., • Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients., • Provides training and guidance on analytical tests, methods, and instrumentation, as required., • Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change., • Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients., • Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients., • Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others., • Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products., • Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards., • Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Education and Experience • Bachelor's degree in chemistry/biochemistry, or a closely related field., • Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred. Required Knowledge and Skills Required Knowledge • Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development., • Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures., • Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns., • Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations., • Understanding of broad testing tools, equipment, and calibration., • Computer applications and systems related to the work., • Principles and practices to serving as an effective project team member., • Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations., • Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas., • Overseeing and administering broad and varied chemistry/biochemistry/formulation functions., • Ability to operate and train others in analytical instruments and manufacturing equipment., • Training others in policies and procedures related to the work., • Serving as a team member and the development and management of projects., • Operating in a both a team and individual contributor environment., • Interpreting, applying, and explaining applicable laws, codes, and regulations., • Preparing advanced to expert functionals reports, correspondence, and other written materials., • Using initiative and independent judgment within established department guidelines., • Using tact, discretion, and prudence in working with those contacted during the work., • Performing effective oral presentations to large and small groups across functional peers and the department., • Contributing effectively to the accomplishment of team or work unit goals, objectives and activities., • Establishing and maintaining effective working relationships with various individuals contacted in the work. Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job Description The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Sr. Program Manager supports client programs through Process Development and into GMP Manufacturing of gene therapy viral vectors. The Sr. PM is well-versed in contract clinical manufacturing and effectively delivering client projects in a fast-paced environment. The Sr. Program Manager will act as the primary contact between clients, Genezen project team members, and functional groups to track progress and ensure the delivery of quality products and services. They will be responsible for developing, tracking, and reporting on the projects. They will effectively monitor and present project updates to relevant stakeholders, clients, and project team members. ESSENTIAL JOB FUNCTIONS • Deliver client satisfaction through timely, effective communication and facilitation of expectations with stakeholders, • Prepare detailed project schedules, including identification of major milestones for overseeing, controlling, communicating, and managing all activities required to complete client projects, • Monitor projects and help resolve issues or escalate appropriately to ensure on time delivery of all milestones and help identify risk mitigation plans, • Organize, set agenda for, and lead meetings with clients and internal teams to facilitate project completion, • Ensure that project deliverables are client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements, • Deliver project status updates to team members and clients during all stages of the project, manage expectations, and escalate risk immediately, • Build strong relationships with clients and collaborate with business development to obtain new business opportunities from existing clients, • Monitor project costs and prepare regular project updates with management and clients, • Support company financial goals and objectives by supporting forecasting processes, assuring timely invoicing of project milestones, and supporting finance department in resolving disputes related to accounts receivable from clients, • Identify appropriate applications and methods in managing projects, • Adaptability required as work schedule may change based on business needs, including flexibility for different time zones, • Criminal background check required EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired BS degree in scientific field Essential BS degree in life sciences Desired PMP training or certification Desired ON-THE-JOB EXPERIENCE 5+ years of experience effectively managing projects in pharmaceutical or biotech company, CDMO, CRO, or related experience Essential 3+ years of life science laboratory experience, especially cell culture, molecular biology, virology Desired SKILLS / ABILITIES Exceptional communication and interpersonal skills, with the proven ability to influence without direct authority. Essential Strong leadership capabilities to motivate and hold cross-functional teams accountable. Essential Excellent organizational and problem-solving skills, with the ability to manage competing priorities and high-pressure situations. Essential Proficient in MS Office Suite, including MS Project or similar project management software Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Regularly sit for long periods of time Movement Repeated hand movements, typing, use of keyboard and mouse Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 10 pounds Occasionally lift and/or move up to 25 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail Pay Range: The annual salary range for this position is $140,000-$175,000 GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS • Paid vacation days, amount based on tenure, • Paid sick time, • 10 observed holidays + 2 floating holiday + 1 volunteer day, • 401(k) plan with company match up to 6% of salary, vested immediately, • Share Appreciation Rights, • Choice of several healthcare plans, • FSA and HSA programs, • Dental & vision care, • Employer-paid basic term life/personal accident insurance, • Voluntary disability, universal life/personal accident insurance, • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time., • This position requires a criminal background check., • Genezen is an Equal Opportunity Employer., • Genezen participates in EVerify. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

100% Remote Objective / Purpose: As a Clinical Data Validation Engineer, you will work on Clinical Trial Reporting activities delivering listings and visualizations to support clients Clinical Trials. In addition, you will operate in compliance with clients SOPs and processes. Accountabilities: Create data cleaning reporting solutions with appropriate oversight that support the quality and timely delivery of data cleaning, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Create any documentation needed for reports throughout the lifespan of the study and/or asset for all deliverables. Develop a library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Complies with applicable SOPs and work practices. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Supports knowledge development of others on reporting tools that support the accuracy and integrity of study data. Provide programming expertise for data cleaning to efficiently ensure high quality data. Enhances available reporting tools/macros/libraries or creates new ones to support the review of clinical trial data and trial status information for cross-functional use and provides input on data management reporting standards as required. Creates and tests listings for data review. Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Management and medical reviewers. Develop innovative, advanced new concepts that improve processes Education & Competencies (Technical and Behavioral): Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job. Knowledge of drug development process. Understanding regulatory requirements and relevant data standards; CDISC and SDTM knowledge and experience are preferable. Minimum 2 years' experience in programming listings and/or visualizations with any of the following Veeva CDB, JReview and Elluminate. Hands-on experience with report development in Elluminate required. Experience with one of these languages: CQL, SQL, SAS, R, Python. Knowledge of clinical database systems (Metadata Rave, Veeva, InForm). Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.). Strong working knowledge of clinical trial terminology. Must be able to work in a fast-paced environment. Ability to work independently, take initiative and complete tasks to deadlines.

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 . About Cemsidomide: Cemsidomide is an investigational, orally bioavailable small-molecule degrader designed to be a more potent and selective degrader of IKZF1/3, transcription factors that drive multiple myeloma (MM), with unique pharmacokinetic properties. Data from the Phase 1 trial demonstrate cemsidomide’s favorable safety and tolerability profile and class-leading anti-myeloma activity, supporting clear development paths for second line and later patient populations. C4T plans to advance cemsidomide through two clinical trials that will position the medicine for two distinct potential accelerated approvals. Job Summary: In this role, reporting to the President & Chief Executive Officer, you will bring together the various functions involved in advancing Cemsidomide through registrational development and FDA approval to define, lead, and drive the execution of our plan to ensure a successful commercial product. Your combination of drug development, commercialization and launch expertise, strategic thinking, and collaborative leadership will be key as you oversee the execution of a strategy that will be enthusiastically received by global regulators and potential patient populations. Your experience in guiding clinical-stage hematological oncology assets into registrational development and commercialization will help you build strong partnerships across functions and with external collaborators. You will work to develop shared understanding across perspectives, align the team on program goals, and create conditions for successful execution. This role offers meaningful visibility across the organization, including closely partnering with the Senior Leadership Team, and the opportunity to make a lasting, positive impact on patients globally as part of C4T’s mission. Your Role: • Lead the intersection of scientific, commercial and business aspects of the Cemsidomide program, including designing and delivering strategic development plans that reflect patient and commercial insights, defining milestones and key deliverables for needs across development and lifecycle management, ensuring that strategies are informed by evidence, clinical insights, and the evolving commercial and patient landscape., • Represent the program internally and externally, building relationships with groups that will be pivotal to commercial success and highlight the potential future of the asset (i.e. patient advocacy groups, key medical experts, policy makers, payors etc.); contribute to business development activities such as evaluating in-licensing or out-licensing opportunities., • In collaboration with Program Manager, develop, implement, and maintain integrated project management plans covering program scope, timelines, budget, communications, risks, staffing, and change management — partnering with Finance, HR, and other functions as needed., • Anticipate challenges early, develop thoughtful solutions, and ensure contingency plans are in place., • Facilitate cross-functional team meetings, fostering a constructive environment, encouraging open discussion, and ensuring decisions and action items are addressed to completion., • Bachelor’s Degree, with at least twelve years of experience in biotechnology or pharmaceutical development, including a strong record in both late-stage and commercial program leadership for hematological oncology products., • An understanding of the scientific principles behind C4T’s research and development, as well as broad knowledge of the biotechnology market, regulatory landscape, drug development process, global product registration, market dynamics, launch and pricing strategies, and business development., • A collaborative leader who can build rapport and authority by leveraging strong interpersonal skills to figure out barriers to engagement and build healthier teams; comfort with seeking out internal or external experts to understand roadblocks, using this knowledge to build deeper relationships, and build consensus on best path forward for the program., • Proven matrix leadership skills with a comfort shifting easily between strategic thinking and practical execution to resolve conflicts and build consensus with individuals of varied disciplines and levels, both internal and external., • Skilled in communicating with clarity across audiences and levels in writing, verbally, and through presentations — providing the right context, listening actively, and working toward shared understanding.

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.

Job Description Position: Talent Acquisition Partner Salary Range: $70,000 - $100,000 Location: Waltham, Boston, MA (Min 3 days per week onsite) About Pharmaron Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: We're looking for a proactive and detail-oriented Talent Acquisition Partner to support hiring across all our roles in the life sciences sector. You will be involved in leading end-to-end recruitment, developing sourcing strategies, and ensuring an exceptional candidate experience. You'll collaborate closely with and serve as a consultative partner to hiring managers by providing insights and guidance to support effective decisions. You will guide compensation recommendations, lead negotiations, ensure seamless integration of new hires into the organization and help strengthen our employer brand. If you're organized, tech-savvy, and passionate about connecting people with meaningful opportunities, this role is for you! ROLES & RESPONSIBILITIES • Partner with Hiring Managers to identify current and future personnel needs., • Partner with Hiring Managers throughout the entire recruitment process from initial role definition through to successful hire., • Enhance the selection process and standards through support and training for Hiring Managers., • Suggest new, innovative ideas to attract highly talented people from diverse backgrounds and continue to build on and enhance, the activities/programmes, processes, systems and reporting associated with talent attraction and talent management (including improved automation of processes)., • Lead and support the HR Recruitment team with recruitment and onboarding activities., • Actively recruit desired talent directly., • Calculate recruiting KPIs (e.g. time-to-hire and time-to-fill)., • Own the candidate experience and continuously work to improve this ultimately promoting the brand and reputation of Pharmaron as the leading CRO in the US QUALIFICATION & EXPERIENCE • BSc degree in Human Resources or an equivalent degree., • Degree and/or PhD in Chemistry or relevant scientific discipline would be desirable., • Evidence of strong recruitment experience and achievement with at least 7 years in applicable role, of which 3 years should have been as an internal recruiter., • Recruitment experience and evidence of successful placement of science candidates in the Pharmaceutical/Life Sciences sector is essential, • Hands-on experience with candidate sourcing and interviewing, • Experience of working in a fast-paced environment, • Experience in mapping and improving processes and systems, • Graduate recruitment experience would be an advantage KNOWLEDGE & SKILLS • Understanding of full cycle recruiting, • Excellence in utilization of recruitment search tools such as LinkedIn Recruiter, • Familiarity with online job-hunting websites, • Familiarity with Applicant Tracking Systems and resume databases, • Proven ability to speak the language of scientists, • Excellent relationship building skills with hiring managers, • Expertise in the production of compelling advertising copy, • Excellent interviewing skills and ability to identify desirable candidates, • Excellent judge of character, • Accurate with a close attention to detail, • Effective written and oral communication skills, • Excellent presentation skills, • Proven negotiation skills Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance, • 401k plan with generous employer match, • Access to an Employee Assistance Program How to Apply: Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-NV1

Job Description Job Title: Research Administrator II Job Description We are seeking a Research Administrator II to manage a complex and large portfolio of research grants, including both pre and post-award functions. Our organization is internationally renowned for its commitment to cutting-edge research and excellent patient care, uniquely positioning us to develop, test, and gain FDA approval for new cancer therapies. Responsibilities • Manage a complex and large portfolio of research grants., • Oversee pre and post-award functions., • Ensure effective grants management and compliance with relevant regulations., • Experience in grants management, including pre and post-award processes., • Strong communication skills., • 1-2 years of experience in research administration. You will be working one day per week on-site (preferably Thursday, but flexible) within a supportive and collaborative team of 14 members, including the director, managers, and research associates. The team values hard work, support, and open communication, fostering a friendly and outgoing atmosphere. Job Type & Location This is a Permanent position based out of Boston, MA. Pay and Benefits The pay range for this position is $75000.00 - $83000.00/yr. Company will discuss benefits, PTO, holiday, sick time schedules with candidate in the offer process. Workplace Type This is a hybrid position in Boston,MA. Application Deadline This position is anticipated to close on Dec 15, 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.