More jobs:
Senior Principal Scientist, Nonclinical Drug Safety
Job in
Newton, Middlesex County, Massachusetts, 02165, USA
Listed on 2026-09-12
Listing for:
Jobtailor
Apprenticeship/Internship
position Listed on 2026-09-12
Job specializations:
-
Research/Development
Regulatory Compliance Specialist
Job Description & How to Apply Below
- Serve as the NDS Therapeutic Area Leader for Immunology
- Oversee progression of nonclinical development programs and post-marketing support within Immunology
- Develop nonclinical strategies, risk assessments, and regulatory submissions supporting global clinical development, product registration, and post-marketing commitments
- Engage with health authorities, consortia, and scientific organizations to shape the external scientific and regulatory environment
- Provide scientific and strategic oversight for Immunology candidates in collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and/or Preclinical Development
- Partner with Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC functions
- Identify potential program issues and guide Compound Leaders through ambiguity and complexity toward timely, risk-balanced resolution
- Coach, mentor, and provide scientific leadership to Compound Leaders and Discovery Program Leaders
- Foster a leadership culture balancing coaching, empowerment, accountability, and talent development
- Strategically plan across Immunology programs and identify resource needs, prioritization considerations, and emerging risks
- Provide mentorship and partner with Compound Leaders on nonclinical program design, toxicology study design, weight-of-evidence risk assessments, waiver strategies, and integrated safety development plans
- Lead nonclinical risk assessments and regulatory documentation for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, regulatory responses, and other legal or scientific documents
- Collaborate with Discovery Program Leaders on emerging Immunology discovery projects
- Contribute to global nonclinical development strategy through scientific publications, external consortia, and cross-industry collaborations
- Lead internal cross-departmental initiatives to improve policies, procedures, and strategic direction
- Serve as Compound Leader for assigned development compounds when needed
- Oversee or conduct NDS due diligence reviews for relevant in-licensing opportunities
- Contribute to the company’s external scientific and regulatory reputation through immunology expertise
- PhD, DVM, and/or MD degree with graduate and/or post-graduate work and/or residency training in Toxicology, Immunology, Pharmacology, Pathology, or a related field
- Minimum of 12 years of experience in toxicology, immunology, pharmacology, pathology, or a related field
- Pharmaceutical program team experience
- Demonstrated expertise in nonclinical drug development and/or relevant regulatory experience with a health authority
- Experience collaborating with and mentoring program team representatives
- Solid experience with regulatory processes, nonclinical risk assessments, ICH guidelines, and Good Laboratory Practice (GLP) requirements
- Expertise in nonclinical drug development across discovery, early development, and late development
- Relevant graduate training in immunology and/or substantial experience providing program team representation or scientific oversight for immunology programs
- Strong scientific acumen, intellectual curiosity, persistence, and a demonstrated track record of success across multiple phases of drug development
- Strong leadership skills and ability to build effective partnerships in a matrixed environment
- Ability to collaboratively influence strategic direction and foster mentorship, empowerment, accountability, talent growth, and program success
- Excellent organizational skills
- Strong verbal and written communication capabilities
- Ability to develop and deliver clear, concise, scientifically rigorous nonclinical documents and presentations
- Experience authoring and critically reviewing nonclinical…
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×