Head of Development
Location: Leuven/Flexible/Remote
Job Type: Full-time
About Us: Onco3R is a dynamic and innovative biotech start-up company committed to transform the lives of patients with autoimmune diseases and cancer. We are seeking a Head of Development to lead and execute our global development strategy across a growing pipeline of innovative therapeutics.
Scope of the job
As a key member of the leadership team, you will be responsible for shaping and executing the development strategy from IND-enabling studies through to clinical proof of concept and beyond for all molecules in the Onco3R portfolio.This is an exciting opportunity to shape the development organization within a fast-paced, entrepreneurial biotech environment.
The ideal candidate will have experience in clinical development, clinical pharmacology, regulatory affairs, toxicology and CMC with strong leadership capabilities, and a proven track record of hands on experience in contributing to the development of molecules.
Key responsibilities
Strategic Leadership
Define and drive the integrated development strategy across nonclinical and clinical functions
Serve as a key member of the leadership team, contributing to corporate strategy, fundraising, and partnerships
Prioritize pipeline assets and align development plans with scientific, regulatory and commercial objectives
Program Oversight
Oversee the planning and execution of IND-enabling studies, first-in-human (FIH) trials, and early clinical development
Guide the design of efficient, robust clinical trials in alignment with company strategy
Ensure cross-functional coordination between Clinical Development, Clinical Operations, Regulatory, CMC and preclinical safety teams
Regulatory & Health Authority Engagement
Contribute to regulatory strategy and interface with regulatory authorities as appropriate
Ensure timely and high-quality preparation of regulatory submissions
Team Building & Leadership
Build and lead a high-performing development team, including internal staff and external consultants/CROs
Foster a collaborative culture across development functions
Budget & Vendor Management
Manage development budgets and timelines; oversee CROs and external partners to ensure delivery and quality
Job requirements
Advanced degree in life sciences or medicine (MD, PhD, PharmD preferred)
12+ years of drug development experience in the biotech or pharmaceutical industry
Demonstrated success advancing programs from preclinical through Phase 1/2
Experience leading cross-functional development teams and external vendors
Strong knowledge of regulatory pathways and clinical trial design (experience with rare diseases, oncology, or immunology is a plus)
Excellent leadership, communication, and strategic thinking skills
Benefits
Competitive salary and benefits package.
Opportunity to work in a fast-paced and innovative environment.
Opportunity to help shape the growth of the company.
How to Apply
Interested candidates should submit their resume and cover letter to contact@onco3R.com