Sr. Principal Scientist, Nonclinical Drug Safety
Scorpion Therapeutics
Responsibilities: Serve as NDS Therapeutic Area Leader for Immunology, overseeing nonclinical development programs and post-marketing support. Deliver nonclinical strategies, risk assessments, and regulatory submissions supporting global clinical development, registration, and post-marketing commitments; engage with health authorities/consortia. Provide scientific/strategic oversight for Immunology candidates in collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and cross-functional R&D partners. Lead situational problem-solving to identify program issues and guide resolution through ambiguity/complexity. Coach/mentor Compound Leaders and Discovery Program Leaders; foster a coaching/empowerment/accountability culture. Drive strategic planning across Immunology programs; identify resource needs, prioritization, and emerging risks. Influence immunology nonclinical drug safety via mentorship and partnership on toxicology study design, WoE risk assessments, waiver strategies, and integrated safety plans. Ensure high-quality nonclinical risk assessments and regulatory documentation for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, and regulatory responses. Contribute to global nonclinical strategy via publications and collaborations; lead internal initiatives to improve nonclinical policies/procedures. May serve as a Compound Leader and conduct NDS due diligence for relevant in-licensing. Qualifications (Required): PhD/DVM/MD with training in Toxicology, Immunology, Pharmacology, Pathology, or related field. 12+ years in relevant field with pharmaceutical program team experience and nonclinical drug development and/or regulatory experience. Regulatory processes, ICH guidelines, GLP, and nonclinical risk assessment expertise. Strong leadership in matrixed environments; clear scientific communication and document authoring/review experience. Preferred: Immunology/immuno-oncology experience; multiple modalities; leadership influencing global regulatory strategy. Coaching/strategic oversight; programs advancing to BLA/WMA. Required Skills: Cell line engineering; human health risk assessment; drug development; mentorship; PD/PK; product registrations; risk assessments; strategic planning; toxicity studies/toxicology; innovative thinking; project leadership; omics technologies; clinical judgment. #J-18808-Ljbffr Scorpion Therapeutics
$190.8k - $300.3k
Job DescriptionThe Nonclinical Drug Safety (NDS) Therapeutic Area Leader (TAL) is a senior scientific leader responsible for advancing the vision... ..., Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and/or Preclinical Development, while ensuring...PrincipalSeniorFull timeFor contractorsLocal areaFlexible hours$179k - $236k
...Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical programs, operating as a hands-on scientific leader. We are looking for an accomplished DMPK and bioanalytical scientist with experience in PK study design, bioanalytical method...PrincipalSenior$119.7k - $222.3k
...SummaryLocation: Cambridge MAInternal: Principal Scientist I/IILI#-HybridThe individual will... ...Toxicology line function of Preclinical Safety (PCS). Key areas of responsibility or... ...experience with SEND (Standard for Exchange of Nonclinical Data) packages to provide support for...PrincipalPermanent employmentFull time$176.2k - $277.3k
...are seeking a Discovery Program Leader (DPL) to represent Nonclinical Drug Safety ( NDS ) on discovery research teams and in scientific and strategic... ...industry experience as a non-clinical safety scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety...PrincipalFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$137k - $215.27k
...application is true to the best of my knowledge.Job DescriptionAbout the role:The Pharmacovigilance Scientist, Senior Scientist ensures regulatory compliance and safety of Takeda's products by managing large projects, developing innovative solutions, and leading teams....PrincipalSeniorMinimum wageTemporary workLocal area$119.7k - $222.3k
...biologics/therapeutic proteins, antibody drug-conjugates, radioligand therapies and/... ...and enhance the understanding of nonclinical and clinical PK/PD relationships and development... ...in AI strategy, to be considered for Principal Scientist II. 4+ years of experience to be...PrincipalSeniorFull time$188k - $259k
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Saviance
Boston, MAmore than 2 months ago $190.8k - $300.3k
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Director, Oral Drug Product Development Responsibilities: Lead formulation design, process development, manufacturability assessment... ...and establish manufacturing strategies. Mentor and develop scientists and engineers supporting oral drug product development. Oversee...PrincipalSeniorTemporary work$185k - $240k
...of medicinal chemists, machine learning scientists, structural biologists, biologists, and... ...across Antares. The role is offered at the Principal or Senior Principal Scientist level;... ...Demonstrated, direct contributions to drug discovery programs through the application...PrincipalSeniorWork at office2 days per week3 days per weekAntares Therapeutics
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Cambridge, MA4 days ago - Judo Bio seeks a Senior Scientist to lead bioanalytical assay development and biomarker strategy in support of siRNA discovery and nonclinical programs. You will develop LC-MS/MS methods for oligonucleotides and small molecules, while overseeing CRO partners to deliver...Senior
- Scorpion Therapeutics is seeking a Director of Oral Drug Product Development to lead formulation design, process development, scale... ...oral dosage forms across all development stages. You will mentor scientists, drive cross‑functional CMC/regulatory activities, and advance...PrincipalSenior
$115k - $215k
...translational, and clinical-stage decision making within fast-paced drug discovery environments.Development and deployment of highly... ...functional drug discovery:Highly organized, solutions-oriented scientist with the ability to manage multiple priorities simultaneously...PrincipalSenior- Orna Therapeutics, Inc. seeks a Senior Principal Scientist to drive analytical characterization of circular RNA and lipid nanoparticle therapeutics, focusing on mass spectrometry. You will collaborate with Platform Science, Discovery, and CMC to advance method development...PrincipalSenior
$126k - $234k
Job Description Summary#LI-Hybrid Internal Title: Principal Scientist II or Senior Principal ScientistLocation: Cambridge, MANovartis is a leader... ...apply mechanistic models (PK/PD, QSP, and PBPK/PD) that link drug pharmacology, tissue biodistribution, mechanism(s) of action,...PrincipalSeniorFull time- UCB in Cambridge, MA is seeking a Senior Principal Scientist to lead translational biology drug discovery with emphasis on muscle biology. You will shape in vitro and in vivo models and develop cellular and biochemical assays for early programs across multiple neuromuscular...PrincipalSenior
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$143k - $214.5k
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$148.5k - $214.5k
Job title: Senior Principal Scientist/Principal Scientist, Real-World Evidence & Disease GenomicsLocation: Cambridge, MAAbout the JobJoin Sanofi... ...experimental scientists, you will help shape the future of drug discovery and development across Sanofi's therapeutic areas —...PrincipalSeniorFull time$146k - $236k
...returning insights that improve the AI platform. The successful candidate will reduce the scientific uncertainty behind Flagship’s drug development and investment decisions through mechanistic modeling and quantitative analysis. The individual will work across the portfolio...PrincipalSenior- Vertex is seeking an experienced scientist to help develop analytical control strategies for small molecule drug substances across clinical and commercial‑enabling phases. You will collaborate with CMC functions and external vendors to design and execute studies that inform...PrincipalSenior
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$214.1k - $337k
Job DescriptionSenior Principal Scientist - Boston, MAOverviewWe are seeking a Senior Principal Scientist to provide scientific and strategic... ...mass spectrometry-based assay development and application to drug discovery.Strong understanding of the drug discovery process,...PrincipalSeniorFull timeFor contractorsLocal area- Vertex Pharmaceuticals Inc in Boston seeks a Senior Principal Scientist to develop and deploy AI-enabled scientific workflows for drug discovery, focusing on small molecules. You will collaborate with cross-functional teams to translate scientific requirements into production...PrincipalSenior
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