Director, Nonclinical Safety — Strategy & Leadership
Nimbus Therapeutics
The role interfaces with CMC, Clinical, Medical, Regulatory Affairs, and Program teams to shape data generation, support IND/CTA filings, and guide development of small molecule candidates. Successful candidates bring deep toxicology leadership, strong communication, and a track record of delivering high-quality safety programs in a fast-paced biotech environment. #J-18808-Ljbffr Nimbus Therapeutics
- Director of Nonclinical Safety, Cambridge, MA Cambridge, MA Isomorphic Labs is applying frontier AI to... ...phase-appropriate nonclinical safety strategies as well as pioneering the... ...programs. What you will do Functional Leadership & Capability Building Lead, build,...SuggestedWork at office3 days per week
$212k - $333.19k
...decision carries real cost, and the safety call is the one that stops a program or sends it forward. As Nonclinical Safety Lead, you own the safety strategy that supports every candidate in... ...how they want to work today.AIRx Leadership CapabilitiesThrive in an environment...SuggestedMinimum wageTemporary workLocal areaImmediate startRemote work$225k - $285k
Director/Senior Director, Nonclinical Safety Nimbus has an outstanding opportunity for an exceptional Director /... ...team. This role will lead the safety strategy, through both preclinical and... ...through regulatory submission Strong leadership competencies and management...SuggestedContract work$152.6k - $283.4k
...you will provide global, end to end nonclinical safety leadership across multiple modalities in the Oncology... ..., and regulatory compliant safety strategies that enable successful clinical... ...toxicologist, pharmacologist, study director).• Demonstrated expertise across multiple...SuggestedFull timeRelocation package$176.2k - $277.3k
...Discovery Program Leader (DPL) to represent Nonclinical Drug Safety (NDS) on discovery research teams and... .... This position requires exceptional leadership, collaboration, and independence, and... ...for defining and overseeing the NDS strategy for programs in all modalities (...SuggestedFull timeFor contractorsLocal areaWorldwideFlexible hours$100k - $250k
Nonclinical Safety & Pharmacokinetics, Director, Contract, Onsite Contract Director, Developability and Early CMC... ...provides scientific and strategic leadership in early CMC development. The Director... ...the early‑stage CMC development strategy and execution for monoclonal and...Full timeContract workImmediate start- Isomorphic Labs is seeking a Director of Nonclinical Safety to build and lead our AI-enabled nonclinical safety function for Early Development. You will own phase-appropriate safety strategies, integrate AI models with traditional data, and ensure robust translational plans...
- ...Companies in Cambridge, MA, seeks a senior leader to provide global, end-to-end nonclinical safety leadership across oncology modalities, ensuring robust, regulatory-focused safety strategies for clinical trial initiation and registration. This hybrid role is based in...Relocation package
$185.5k - $344.5k
...line function of Preclinical Safety (PCS). This team is... ...for establishing long-term strategy and yearly goals which support... ...SEND (Standard for Exchange of Nonclinical data) datasets are of high-quality... ...people management or leadership experienceGood communication...Full time- ...Co., Inc. in Rahway, NJ, USA seeks a senior Nonclinical Drug Safety TAL to lead Immunology programs, shape regulatory strategy, and mentor cross‑functional teams. This role... ...compliant development, sponsor scientific leadership, and foster mentorship within a hybrid work...
$209k - $376k
Join to apply for the Head of Nonclinical Safety Evaluation role at BioSpace... ...driving nonclinical safety strategies across Moderna’s mRNA... ...incumbent will fulfill a key leadership role within our organization... ...00-$327,800.00 1 month ago Director, Global Environmental, Health...16 hoursPermanent employmentFull timeWork at officeRemote workWork from home- Alexion Pharma Spain S.L. is seeking a Director, Safety Scientist in Boston to lead a team of... ...and shape the global pharmacovigilance strategy. You will oversee safety content,... ...7+ years in drug safety, with strong leadership and cross-functional collaboration. Expect...
- ...Therapeutics, Inc is seeking a Director or Senior Director of Nonclinical Toxicology & PK to provide scientific leadership across multispecific antibody programs... .... You will own nonclinical safety, PK, and clinical translation strategies from discovery through IND-enabling...
- ...Management Services, LP in Cambridge, MA seeks an EHS Director to lead environmental, health and safety programs across all departments. The role focuses on... ...with 5-8 years of experience, strong auditing and leadership skills, and familiarity with the 4Insite software. Regular...
- ...is seeking a hybrid-embedded Preclinical Safety leader in Cambridge, MA. You will guide... ...teams across modalities, shaping safety strategies to enable clinical entry and regulatory... ...top-level advanced degree with extensive nonclinical experience, strong regulatory credibility...
$185.5k - $344.5k
...Cambridge MA | Internal: Director | LI#-Hybrid This... ...function of Preclinical Safety (PCS). The team is... ...establishing long‑term strategy and yearly goals. Modernize... ...for Exchange of Nonclinical Data) datasets are of... ...people management or leadership experience. Strong communication...- Vertex Pharmaceuticals seeks a Director of Intellectual Property Operations in Boston, leading a team... ...IP function. The position combines strategic leadership with hands-on execution, focusing on budgeting, technology strategy, and cross-functional collaboration to scale...
$210k - $235k
...clinical development, commercial strategy, and beyond. Innovation: Work... ...and geographies. The Director, Regulatory Strategy provides global regulatory leadership and strategic direction across... ...Development, Biostatistics, CMC, Nonclinical, Pharmacovigilance, Quality, and...Remote workWorldwideFlexible hours$180k - $245k
...is seeking an experienced and strategic Director of Regulatory Affairs to lead and... ...for developing and executing regulatory strategies that support global product development... ...requires strong regulatory knowledge, leadership skills, and the ability to work effectively...- Novartis is seeking a leader for global preclinical safety to guide nonclinical safety programs across multiple modalities. You will influence development strategy, interact with Health Authorities, and ensure robust, regulatory-compliant safety packages for clinical trial...
- ...and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory... ...organization. This is a high-impact leadership role focused on providing... ...regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling...
- ...Cambridge, MA, seeks a seasoned scientific leader as the Head of Nonclinical Safety Evaluation. This role involves overseeing Toxicology and Pathology functions and driving nonclinical safety strategies across the mRNA pipeline. The ideal candidate will have over 15 years...
$200k - $250k
OverviewThe Director of Drug Safety & Pharmacovigilance provides strategic and hands‑on leadership for pharmacovigilance activities supporting a clinical‑stage biotech pipeline... ...establishing and executing global safety strategy across early‑ and mid‑stage clinical...$190k - $215k
...as we are! Your Impact As Associate Director, Regulatory Strategy, you'll help define the regulatory... ...meaningful ownership, direct exposure to leadership, and the opportunity to grow your... ..., CMC, clinical pharmacology, and nonclinical Accountable for the maintenance of...Full timeWork at officeLocal areaImmediate start- ...and energetic Associate Director, Regulatory Affairs to... ...global regulatory strategy, lead submission planning... ...to work closely with leadership and cross‑functional teams... ..., including clinical, nonclinical, and CMC activities.... ...CTAs, annual reports, safety reports, meeting...
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston... ...Accountabilities:Global Regulatory Leadership: Own the end-to-end global... ...regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ...of regulatory strategy through the clinical and nonclinical development processes. Identifies potential areas of regulatory...Permanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
...individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape... ...requires a seasoned regulatory leader who embodies Moderna’s leadership principles: acting with urgency, challenging convention,...Permanent employmentFull timeWork at officeWork from home- SimpliSafe is seeking a Director of Tax to lead our global tax strategy, operations, and compliance as the business scales. You will guide planning initiatives, ensure domestic and international tax compliance, and safeguard the company’s tax position. Collaborate across...
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical... ...from cross-functional teams and GRA leadership. Counsels and advises senior management... ...and interpreting data, protocols, safety reporting, labeling and other activities...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week
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