Senior Director/ Director Regulatory Strategy Vor Biopharma Inc.Senior Director/ Director Regulatory StrategyBoston, MA$210,000–$235,000 / yearPartner closely with Clinical Development, Biostatistics, CMC, Nonclinical, Pharmacovigilance, Quality, and Commercial teams to align regulatory strategy with development and commercialization goals. The Senior Director/ Director Regulatory Strategy provides global regulatory leadership and strategic direction across one or more development programs in immunology.
Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU) PrileniaDirector / Senior Director, GCP Quality Assurance Lead (US/IL/EU)Europe, MassachusettsRemoteAbout Prilenia Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, GCP Quality Assurance Lead, to support programs in both Huntington’s Disease and ALS. The ideal candidate is both a hands-on quality practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GvP/GLP expertise with the executive presence to influence cross-functional teams and senior leadership.
Associate Director/ Senior Clinical Trial Manager Thorough GroupAssociate Director/ Senior Clinical Trial ManagerBoston, MassachusettsAs the organization continues to advance its pipeline, they are seeking an experienced and highly motivated Associate Director or Senior C linical Trial Manager (CTM) to provide operational leadership for ongoing and upcoming clinical studies. This individual will play a critical role in study start-up, site activation, enrollment strategy, risk management, and overall trial execution while collaborating closely with cross-functional stakeholders across the organization.
Clinical Trial Manager/Senior Clinical Trial Manager Oruka Therapeutics, Inc.Clinical Trial Manager/Senior Clinical Trial ManagerWaltham, MA$146,000–$161,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Key Responsibilities: Clinical Trial Management: Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
Medical Director, Clinical Development Dyne TherapeuticsMedical Director, Clinical DevelopmentWaltham, MA$270,000–$310,000 / yearThis role serves as the medical monitor on their assigned study(s), partnering closely with Clinical Development leadership, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, and other key stakeholders to support study design, protocol execution, medical review, data analysis, and regulatory deliverables. This role is responsible for ensuring participant safety, supporting high-quality study execution, interpreting emerging clinical and safety data, and providing timely medical input to study teams, investigators, vendors, and cross-functional partners.
Project Manager Alira HealthProject ManagerBoston, MassachusettsCreates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.
Associate Director, Clinical Scientist Zenas BioPharma (USA) LLCAssociate Director, Clinical ScientistWaltham, MA$161,700–$202,200 / yearThis position works closely with Medical Directors to support medical monitoring activities, while partnering cross-functionally with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Medical Affairs, and Regulatory Affairs to translate clinical strategy into operational deliverables and ensure rigorous ongoing review of trial data for quality, safety, and protocol compliance. Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody.
Clinical Trial Associate II Prometrika LLCClinical Trial Associate IICambridge, MACTA/CTM, develop study specific processes to ensure that necessary study supplies are available at sites as required, coordinating with appropriate vendors as needed (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.). The Clinical Trial Associate II (CTA II) supports, coordinates, and implements clinical research projects, working with the study team in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and SOPs/WPDs.
Clinical Scientist, Associate Director Candel TherapeuticsClinical Scientist, Associate DirectorNeedham, MAFull timeCandel Therapeutics is seeking an experienced and intellectually curious Clinical Scientist to support our oncology clinical development programs, with an initial focus on prostate cancer and opportunities to contribute across additional solid tumor programs, including lung and brain cancer studies. Author and contribute to key clinical and regulatory documents including Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, informed consent forms (ICFs), DSURs, clinical narratives, and IND/BLA regulatory submissions.
Medical Director Relay Therapeutics, Inc.Medical DirectorCambridge, MAYour Role: Collaborate with senior medical staff, drug discovery teams, translational oncology, clinical operations, clinical investigators and disease-specific experts to design and execute early clinical development plans that definitively test key translational hypotheses for Relay Tx medicines and establish clinical proof-of-concept as soon as possible after entering human testing. Working cross-functionally with clinical project management, regulatory affairs, clinical operations, biostatistics, data management and medical writing, you will play a key role as Relay Tx continues to introduce product candidates into the clinic.
Associate Director, Clinical Science eGenesisAssociate Director, Clinical ScienceCambridge, MA$175,000–$226,000 / yearThe successful candidate will contribute to the design and execution of clinical development strategies, support regulatory submissions, and drive continuous improvement across clinical development processes and initiatives in a collaborative, science-driven biotech environment. Contribute to the preparation of clinical sections of regulatory submissions and supporting documents, including INDs, briefing documents, BLAs, Safety and Annual reports, and responses to regulatory agencies regarding questions about clinical development issues (e.g., safety or efficacy).
Clinical Trial Manager Prometrika LLCClinical Trial ManagerCambridge, MAExperience working in cross-functional teams and direct involvement in protocol and CRF development is highly valued Proven track record of ensuring GCP/regulatory/protocol compliance, managing timelines and budgets, leading risk assessments, and implementing CAPAs and KPIs SKILLS Working knowledge of the clinical drug development process Strong knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines Strong analytical and problem-solving skills Written, verbal communication and presentation skills in small and large group settings Must possess excellent interpersonal skills Mentoring/coaching Ability to effectively multi-task and prioritize Organizational skills and attention to detail required Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint Cross functional and cross-cultural awareness Ability to work in a matrix environment. RESPONSIBILITIES The Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, study protocol, company goals, and budgets.
Manager, Medical Writing Prometrika LLCManager, Medical WritingCambridge, MAEXPERIENCE A minimum of 10 years experience in biotechnology/pharmaceutical industry A minimum of 7 years regulatory writing in biotechnology/ pharmaceutical industry Experience managing medical writers or contractors preferred Previous experience in developing clinical and regulatory documents, such as protocols, CSRs, IBs, INDs, ISS/ISE, and DSURs. This role requires writing and editing of protocols and scientific and clinical reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication.
Computational Biologist - Spatial Multi-Omics Bayer AGComputational Biologist - Spatial Multi-OmicsCambridge, MA$106,400–$159,600 / yearThe primary responsibilities of the Director, Computational Biologist - Spatial Multi-Omics are to: Build and maintain scalable pipelines for spatial and deep visual multi-omics analysis, including data ingestion, QC, normalization, batch correction, feature extraction, and annotation from mass-spectrometry and transcriptomics platforms. Bayer seeks an incumbent who possesses the following: Required qualifications: PhD in Computational Biology, Bioinformatics, Systems Biology, Biostatistics, Computer Science, or related field; or MSc with substantial relevant experience.
Senior Director, Regulatory Affairs Bicara Therapeutics IncSenior Director, Regulatory AffairsBoston, MAFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Medical Director, Medical Affairs Beeline MedicinesMedical Director, Medical AffairsBoston, Massachusetts$266,000–$344,000 / yearLead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs together with the development team— sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights (such as in depth knowledge of the patient journey from diagnosis to treatment along with barriers that are encountered along the way) that inform medical strategy, pipeline positioning, and commercial readiness. Partner with Field Medical Affairs and MSL teams to ensure accurate, balanced, and up-to-date scientific tools and resources are available and consistently applied in field engagements — participating directly in key field interactions when the scientific complexity or stakeholder importance warrants senior medical presence.
Senior Director, Clinical Dosimetry & Radiation Sciences Alpha-9 Oncology, Inc.Senior Director, Clinical Dosimetry & Radiation SciencesBoston, MAThis role operates at the intersection of clinical development, clinical pharmacology, regulatory affairs, and external imaging partners, with direct influence on how quantitative radiopharmaceutical data is translated into clinical decisions. Reporting into Clinical Development, this role serves as the internal scientific lead for dosimetry methodology and imaging quantification, ensuring rigor, consistency, and interpretability across multiple active studies.
Medical Director AVEO OncologyMedical DirectorBoston, MAThe successful candidate will have a strong background in oncology, specifically renal cancer, previous experience in early phase development strongly preferred; and a proven track record in managing global clinical trials. 2. Medical Monitoring and Safety Oversight: · Serve as the medical monitor for assigned clinical trials, providing ongoing medical oversight and guidance, addressing any issues that arise to ensure timely completion and high-quality data.
Executive Director, Clinical Development Centessa Pharmaceuticals, LLCExecutive Director, Clinical DevelopmentBoston, MA$300,000–$375,000 / yearStrong knowledge in clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc. Lead clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, ad hoc safety reports (SUSARs), interim and final CSRs, etc.
Director, Clinical Program Management Alkermes PlcDirector, Clinical Program ManagementWaltham, MAIn 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.