Stealth-mode biotech with an innovative approach to antibody-based therapeutics in the immunology space seeks a Senior Director or Director of Preclinical Development to drive our IND-enabling efforts with a proven track record of advancing antibody-based programs from DC nomination into clinical development.
This role will involve managing a small team and overseeing preclinical activities, including leading GLP and non-GLP PD and toxicology studies in NHPs at CROs.
Highlights
- Founded and backed by a blue-chip investor
- Newly created role due to company growth
- Multiple programs in pipeline
- Reports to VP, Immunology
Key Responsibilities
- Leadership: Lead pre-clinical IND-enabling activities for antibody programs, specifically focusing on bi- or multi-specific antibodies, to support successful IND submissions and progression to clinical trials.
- Study Design & Oversight: Design studies, author protocols, lead, and interpret in vivo IND-enabling studies, including non-GLP and GLP pharmacokinetics (PK), pharmacodynamics (PD), toxicology, dose-range finding, and biodistribution studies in NHPs.
- IND-Enabling Expertise: Provide hands-on expertise and guidance on all aspects of IND-enabling preclinical activities.
- Strategic Leadership: Develop and implement the preclinical strategy for antibody programs, specifically focusing on bi- or multi-specific antibodies, to support successful IND submissions and progression to clinical trials.
- Data Analysis & Interpretation: Critically analyze and interpret complex preclinical data, draw sound conclusions, and effectively communicate findings to internal and external stakeholders. Work with toxicologists and statisticians as needed.
- Team Management: Manage and mentor a team of 1-2 direct reports.
- CRO Management: Select, oversee, and manage external CROs for outsourced preclinical studies.
- Cross-Functional Collaboration: Collaborate effectively with discovery, CMC, clinical, regulatory, and project management teams to ensure seamless program progression.
- Regulatory Submissions: Author or contribute to the authorship and review of technical reports, pre-clinical sections for regulatory documents, including INDs, Investigator's Brochures (IBs), and other regulatory filings.
- Quality & Compliance: Ensure all preclinical activities are conducted in accordance with relevant regulatory guidelines (e.g., GLP) and internal SOPs.
- Communication: Present preclinical data and strategies clearly and concisely to diverse audiences, including senior management, scientific advisory boards, and regulatory agencies.
Minimum Qualifications
- Ph.D. in Pharmacology, Toxicology, Immunology, Biochemistry, or a related discipline.
- 8+ years of experience in preclinical drug development.
- 3+ years in a leadership role.
- Extensive experience in leading IND-enabling studies for antibody-based therapeutics, including overseeing GLP and non-GLP PD and toxicology studies in NHPs at CROs.
- Extensive hands-on experience designing, executing, and interpreting IND-enabling studies (in vitro and in vivo), including direct experience with in vivo model work.
- Proven track record of contributing to IND submissions for antibody-based therapeutics.
This Company is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
