Senior Non-Clinical Safety Leader — Strategy & Regulatory
UCB Inc.
UCB Inc. in Cambridge, Massachusetts is seeking a Non-clinical Safety Lead to provide scientific leadership in non-clinical safety across regulatory interactions and innovative programs. You will lead and communicate strategies supporting clinical development goals. The ideal candidate possesses a PhD in Toxicology or a related field with over 5 years of experience in non-clinical safety, alongside a strong understanding of regulatory processes. The position offers a competitive salary and engages in groundbreaking projects in gene and cell therapy. #J-18808-Ljbffr UCB Inc.
$132k - $172k
Travere Therapeutics is seeking a Senior Manager, Medical Writing to lead the creation of regulatory, clinical, and safety documents. This role provides strategic guidance and ensures compliance, with responsibilities spanning all phases of clinical development. The ideal...SeniorRegulatoryRemote job- Amylyx Pharmaceuticals seeks a Senior Director of Toxicology to lead nonclinical safety strategy across a multifaceted pipeline. You will partner with Discovery Biology, Regulatory, Clinical Development, and leadership to accelerate safe advancement of therapies from discovery...SeniorRegulatoryRemote job
- Amylyx Pharmaceuticals is seeking a Senior Vice President of Clinical Development to provide strategic leadership for clinical programs... ...trial design and execution while managing regulatory affairs and budget strategies. The ideal candidate should have at least 15 years...SeniorRegulatoryRemote job
- Amylyx Pharmaceuticals is seeking a Director of Biostatistics to oversee statistical leadership in clinical trials and regulatory submission strategies. Your role includes collaborating with internal and external stakeholders to ensure the success of the clinical development...SeniorRegulatoryRemote work
$145.9k - $234.2k
...Role Moderna is seeking a Senior Product Manager - Clinical Safety and Pharmacovigilance... ...support the digital product strategy, operations, and lifecycle... ...in Patient Safety, Regulatory, Quality, Clinical Development... ...employment opportunity and non‑discrimination for all...SeniorRegulatoryPermanent employmentWork at office- ...Lead in Boston, Massachusetts to guide technical strategy and operational execution across clinical programs. This senior role requires a master's or PhD in a... ...extensive experience in statistical programming and regulatory submissions. Join Genentech to foster a culture...SeniorRegulatory
$168k - $220.5k
A global biopharmaceutical company is seeking a Non-clinical Safety Lead in Cambridge, MA. This role involves providing scientific leadership and developing non-clinical safety strategies while managing regulatory interactions and budgets. Ideal candidates will have a PhD...RegulatoryWork at officeWork from home- Senior Director, Program Leader, Corporate Strategy At Agios, we are fueled by connections to transform... ...for a critical clinical stage program. You will... ...clinical development through regulatory approval, launch, and... .... Psychological safety: an environment of fearlessness...SeniorRegulatory3 days per week
$168k - $220.5k
About the role As a Non-clinical Safety Lead, you will provide scientific leadership for non-clinical safety across... ...programs. You will shape non-clinical strategies, ensure high-quality execution, and support regulatory interactions from early development through clinical...RegulatoryLocal area$193k - $210k
...pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle.... ...Responsibilities include ensuring alignment with clinical plans and incorporating global Health...SeniorRegulatory- ...Pharmaceuticals is looking for an imaginative Sr. Medical Director in Clinical Research within the Cardiovascular & Metabolism area. The... ...significant drug development experience and a strong background in regulatory interactions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorRegulatory
- ...seeks an Executive Director, Clinical Leader - Neuropsychiatry to lead the clinical strategy for brain health programs... ...will guide governance, safety oversight, and cross‑functional... ...with medical affairs, regulatory, and operations. This senior role requires a track record...Regulatory
$97.5k - $141.5k
Boston Medical Center (BMC) is seeking a Senior Risk Management Specialist to enhance patient safety and ensure regulatory compliance. This hybrid position involves collaborating... ...'s degree and extensive experience in clinical care and risk management are required. The...SeniorRegulatory$168k - $220.5k
...patients Cambridge, MA (USA) About The Role As a Non-clinical Safety Lead, you will provide scientific leadership... ...programs. You will shape non-clinical strategies, ensure high-quality execution, and support regulatory interactions from early development through clinical...RegulatoryWork at officeLocal area- Solid Biosciences is looking for a Senior Director of Quality Control to lead the QC strategy and manage QC activities for clinical programs. Key responsibilities include providing... ...the QC team, ensuring compliance with regulatory requirements, and overseeing QC...SeniorRegulatory
- ...of Biostatistics to serve as the statistical lead for various clinical programs. You will provide technical leadership and statistical... ...across teams to ensure successful clinical study designs and regulatory submissions. The ideal candidate holds a PhD in statistics with...SeniorRegulatory
- Warman O'Brien is seeking a Vice President/Executive Director for Clinical Development in Boston. This role offers a unique opportunity... ...track record in oncology development and experience with regulatory authorities, particularly the FDA. A collaborative and operational...SeniorRegulatory
$120k - $140k
...Shaping the Future of Clinical Research Adams... ...uncompromising data quality, safety, and diverse... ...We are seeking a Senior Manager, Clinical... ...oversight, regulatory compliance, and ensuring... ...mitigation strategies with senior leadership... ...Operations along with leaders of other...SeniorRegulatoryFull timeWork at officeLocal areaRelocationFlexible hours$131k - $187k
...Senior Clinical Data Manager Repertoire Immune Medicines is a clinical... ...lock, archival, and regulatory submission support. This individual... ...Operations, Clinical Development, Safety, Regulatory, Translational... ...data collection and review strategies. This is a role for someone...SeniorRegulatoryTemporary workWork experience placementWork at officeLocal areaFlexible hours3 days per week- ...As a Senior Director, Global Clinical Program Lead, you’ll play... ...Clinical Practice, and regulatory requirements.... ...patient safety on a study level... ...proposing mitigation strategies to deliver successful... ...payers, opinion leaders, prescribers and... ...regulations on non-discrimination...SeniorRegulatoryTemporary workLocal area
- Amylyx Pharmaceuticals seeks a strategic Senior Director, Clinical Data Management in Cambridge, MA. This pivotal role is responsible for leading... ...function and ensuring high-quality data delivery for regulatory submissions. The ideal candidate will have extensive experience...SeniorRegulatoryRemote work
- Moderna is seeking a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation. The successful applicant will provide strategic... ...and Pathology, overseeing nonclinical safety strategies to support regulatory submissions. This position requires a PhD with...SeniorRegulatory
$275k - $300k
Centessa Pharmaceuticals is seeking a Senior Director, Toxicology in Boston, MA, to lead the development of nonclinical safety strategies for CNS programs. This role involves managing... ...staff, and ensuring compliance with regulatory standards. Applicants should have a PhD...SeniorRegulatoryFull time- ...company in Cambridge seeks a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation to oversee Toxicology and Pathology.... ...strategic leadership in nonclinical safety strategies, and manage regulatory submissions. Essential qualifications include a...SeniorRegulatory
$218.4k - $327.6k
General Summary The Senior Director, BSMO (... ...at the GKD Disease Strategy Team (DST). The... ...Quality, Supply Chain, Regulatory, Finance, and... ...the GKD DST, this leader will partner cross... ...aligned with disease, clinical & commercial... ...employment opportunity and non‑discrimination for...SeniorRegulatoryRemote workFlexible hours2 days per week- ...in Cambridge, MA is looking for a Senior Scientist in Toxicology to lead the pre-clinical safety strategy for oligonucleotide programs. This... ...Responsibilities include managing non-GLP/GLP studies and preparing reports for regulatory submissions. Join a dynamic team at...SeniorRegulatory
- VetJobs is seeking a qualified individual to lead safety activities and manage benefit-risk strategies for assigned BMS compounds/programs at its location... ...oversee safety reviews and ensure compliance with global regulatory standards. The ideal candidate should have an MD or...SeniorRegulatory
$137k - $215.27k
...biostatistics, programming, clinical pharmacology, real-... ..., and patient safety. These professionals... .... Role Overview The Senior Manager,... ...advancing clinical strategies and supporting regulatory interactions. Key Responsibilities... ...complex concepts to non-specialists...SeniorRegulatoryWorldwide$236.25k - $341.25k
...Job title : Senior Clinical Lead, Early Clinical & Experimental... ...of efficacy or safety notably for new indications... ...coordinate work by regulatory, safety/... ...overall development strategy in collaboration with... ...experts, Key Opinion Leaders Ethics committees...SeniorRegulatoryInterim role- ...biotechnology company based in Boston, MA, seeks an experienced SVP of Clinical Development. This role involves strategic oversight of... ...with cross-functional teams, and a strong focus on regulatory compliance. Ideal candidates will have over 15 years of clinical...RegulatoryFull time
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