What are the responsibilities and job description for the Director / Senior Director, Translational & Nonclinical Development position at Planet Pharma?
Position Summary
We are seeking a hands-on Director or Senior Director of Translational & Nonclinical Development with a “builder mindset” to lead nonclinical strategy and execution as we advance toward IND and clinical development.
This individual will lead a focused nonclinical safety (toxicology) and pharmacology strategy, working closely with experienced external partners and advisors on GLP toxicology and translational pharmacology studies to support first-in-human dosing and clinical development.
In parallel, this role will play a central role in advancing next-generation C7 program, including early-stage mechanistic studies, in vitro and in vivo model development, and evaluation of engineered variants designed to improve stability and efficacy.
This broad, high-ownership role is cross-functional and execution-oriented, requiring close coordination with CMC, regulatory, and external partners (CROs, academic collaborators).
Key Responsibilities
We are seeking a hands-on Director or Senior Director of Translational & Nonclinical Development with a “builder mindset” to lead nonclinical strategy and execution as we advance toward IND and clinical development.
This individual will lead a focused nonclinical safety (toxicology) and pharmacology strategy, working closely with experienced external partners and advisors on GLP toxicology and translational pharmacology studies to support first-in-human dosing and clinical development.
In parallel, this role will play a central role in advancing next-generation C7 program, including early-stage mechanistic studies, in vitro and in vivo model development, and evaluation of engineered variants designed to improve stability and efficacy.
This broad, high-ownership role is cross-functional and execution-oriented, requiring close coordination with CMC, regulatory, and external partners (CROs, academic collaborators).
Key Responsibilities
- Nonclinical Strategy and IND-Enabling Development:
- Refine and execute a nonclinical strategy to support IND submission and early clinical development
- Design and oversee a focused set of GLP toxicology studies, supported by CRO’s and advisors, including:
- 28-day repeat-dose systemic toxicity study
- Local toxicity evaluation in disease-relevant wound model
- Leverage external toxicology expertise to ensure study alignment with regulatory expectations and Pre-IND feedback
- Refine dose strategy for first-in-human studies
- Pharmacology & Translational Development
- Lead design and execution of follow-up pharmacology studies to demonstrate biological activity and dose-response
- Integrate internal and external data to inform dosing strategy and trial design
- Support development of biomarkers and in vivo assays to evaluate drug activity and durability
- Lead preparation of nonclinical sections of regulatory submissions (IND)
- Next-Generation C7 Program Leadership
- Lead early-stage development of degradation-resistant next-gen C7 variants
- Oversee studies to:
- Characterize C7 degradation
- Identify sites and mechanisms
- Evaluate engineered variants for improved stability and retained function
- Guide development of in silico, in vitro and in vivo screening systems for variant prioritization
- Coordinate external partners (CROs, protein engineering groups) and internal efforts to advance program milestones
- External Partner & Study Management
- Select and manage CROs and academic collaborators executing toxicology, pharmacology, and translational studies
- Ensure studies are executed with high quality, rigor, and on timeline
- Provide hands-on scientific direction and maintain efficient execution
- Cross-Functional Leadership
- Partner closely with:
- CMC on material selection and study readiness
- Regulatory on strategy and agency interactions
- Leadership / investors on program updates and key decisions
- Contribute to integrated development plans, including timeline, budget, and risk management
- Support broader company strategy across lead and next-gen programs
- Advanced degree in pharmacology, toxicology, biomedical sciences, or related field
- ~10 years of experience in nonclinical development, ideally with biologics or protein therapeutics
- Direct experience overseeing GLP toxicology studies and IND-enabling packages
- Strong understanding of regulatory expectations for biologics
- Experience with translational pharmacology and disease-relevant models
- Demonstrated ability to manage external partners (CROs, academic groups)
- Experience working in small, fast-paced biotech environments preferred
- Ability to communicate and work effectively with cross-functional teams and valued advisors
- Opportunity to lead nonclinical and translational strategy at a formative stage company
- High ownership across both lead clinical program and next-generation pipeline
- Significant growth potential as the company advances into clinical development
- Competitive salary, equity, and benefits