Director / Senior Director, Translational & ...

Job DescriptionPosition 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:• 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 programsQualifications: 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 advisorsWhat We Offer: 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 benefitsEqual Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.

Created: 2026-04-15