This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Director, Early Clinical Development based in the United States.
This is a high-impact clinical leadership role at the forefront of early-stage drug development for genetically defined rare diseases. You will shape and execute clinical development strategies from first-in-human studies through proof-of-concept, directly influencing critical go/no-go decisions across innovative therapeutic programs. Working in a highly cross-functional environment, you will collaborate with experts in translational science, clinical pharmacology, biomarkers, safety, and regulatory affairs to design and deliver high-quality early clinical studies. The role requires strong scientific judgment, strategic thinking, and the ability to translate complex data into clear development decisions. You will also contribute to portfolio-level strategy, support evaluation of new opportunities, and provide leadership within a highly specialized R&D organization. This position combines hands-on clinical oversight with broader strategic influence across an early development pipeline.
Accountabilities:
This role is responsible for leading early clinical development strategy and execution across multiple therapeutic assets, ensuring strong scientific rigor and clear decision-making throughout first-in-human and proof-of-concept stages. You will act as a key clinical leader guiding programs through high-risk development phases while shaping broader portfolio direction.
- Develop and lead early clinical development strategies and integrated clinical development plans from first-in-human through proof-of-concept studies
- Serve as Clinical Development Team Leader across assigned assets, driving cross-functional alignment and strategic execution
- Design and oversee Phase 1 and Phase 2 clinical studies, ensuring high-quality data generation for development decisions
- Contribute to regulatory submissions including pre-IND, IND, and other early-stage filings
- Partner with translational science, biomarkers, clinical pharmacology, and safety teams to design robust clinical and biomarker strategies
- Lead interpretation of emerging clinical data to guide safety, efficacy, and benefit-risk decisions
- Support natural history study design to improve patient characterization and endpoint development
- Provide mentorship and matrix leadership within the early clinical development organization
- Contribute to portfolio evaluation, governance discussions, and external business development assessments
Requirements:
The ideal candidate is an experienced clinical development leader with deep expertise in early-phase clinical research, translational science, and rare disease drug development. You bring strong scientific leadership, cross-functional collaboration skills, and the ability to operate in complex, data-driven environments.
- Medical degree (MD or equivalent) with board certification or relevant clinical training
- Extensive experience in clinical development, with strong focus on early-phase (Phase 1/2) trials
- Proven track record in translational clinical research, ideally within biotech or pharmaceutical environments
- Strong expertise in study design, clinical strategy, and interpretation of complex clinical data
- Experience working with biomarkers, pharmacology, and regulatory submission processes
- Demonstrated leadership in cross-functional teams and ability to influence senior stakeholders
- Experience in rare diseases or genetically defined conditions strongly preferred
- Strong communication skills, with ability to engage scientific experts and regulatory authorities
- Strategic thinker with strong decision-making and benefit-risk assessment capabilities
Benefits:
- Competitive base salary aligned with experience and market benchmarks
- Annual performance-based incentive compensation
- Comprehensive medical, dental, and vision insurance coverage
- Retirement savings plan with company contributions
- Generous paid time off, including vacation, holidays, and sick leave
- Professional development and scientific leadership opportunities
- Participation in a highly innovative, research-driven biotech environment focused on rare diseases
- Collaborative and mission-driven culture centered on patient impact