Senior Medical Director, Early Clinical Development

Senior Medical Director, Early Clinical Development

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