Executive Medical Director, Clinical Development Nephrology

Role Overview

• Lead the overall clinical development strategy for assigned program(s) as a key contributor to indication strategy, target product profile, clinical positioning, and lifecycle planning.
• Serve as the project lead for clinical programs, integrating nonclinical, translational, biomarker, safety, regulatory, and competitive insights into development plans.
• Design and oversee clinical studies across phases, including protocol concept, eligibility criteria, endpoints, safety monitoring, dose selection, and statistical considerations.
• Provide leadership for study conduct, including protocol deviation review and data interpretation.
• Lead analysis and interpretation of clinical data and author or review key documents including protocols, IBs, CSRs, abstracts, manuscripts, and health authority briefing materials.
• Partner with Biometrics to define analysis strategy and ensure clinically meaningful interpretation of efficacy, safety, PK/PD, and biomarker data.
• Serve as the project leader for assigned development program(s), driving cross-functional alignment on program goals, timelines, risks, decision points, and resource needs.
• Lead core team meetings and represent the program at governance forums, providing clear recommendations grounded in data, development risk, and strategic fit.
• Build integrated development plans in collaboration with cross-functional partners and ensure disciplined execution against milestones.
• Identify program risks early and develop mitigation strategies spanning clinical, regulatory, operational, and portfolio considerations.
• Drive scenario planning and decision analyses to support stage-gate and investment decisions.
• Contribute to global regulatory strategy and represent Clinical Development in interactions with regulatory agencies, including FDA, EMA, and other health authorities.
• Help prepare for and participate in key regulatory meetings, including end-of-Phase 2 and other milestone interactions.
• Build and maintain relationships with academic experts, investigators, patient advocacy groups, and other external stakeholders in nephrology and rare disease.
• Support due diligence and business development activities, including assessment of external assets in nephrology or adjacent rare disease areas.
• Partner closely with Clinical Operations to ensure study designs are executable and enrollment strategies are realistic for rare disease settings.
• Collaborate with Non-Clinical teams to incorporate mechanistic and disease-relevant endpoints into development programs.
• Productively interface with Clinical Pharmacology, Pharmacovigilance, CMC, HEOR, Medical Writing, and additional project functional leads not previously listed.
• Work with Medical Affairs and Commercial colleagues to align development plans with future evidence-generation needs and patient/community insights.
• Mentor junior project team members and contribute to building a high-performing clinical development organization.
• Model strong enterprise leadership, balancing program advocacy with portfolio-level thinking.

Requirements

• MD, DO, or equivalent medical degree required
• 10+ years of biotechnology and/or pharmaceutical industry experience in clinical development, with progressive leadership responsibility
• Prior experience leading clinical programs in nephrology, rare disease, or closely related therapeutic areas strongly preferred
• Demonstrated experience serving as a program or project leader in a cross-functional drug development environment
• Strong understanding of clinical trial design, dose selection, safety assessment, endpoint strategy, and interpretation of complex clinical datasets
• Experience with regulatory submissions and health authority interactions
• Track record of leading development strategy through major inflection points such as IND, proof-of-concept, end-of-Phase 2, and/or registrational planning
• Deep appreciation for the unique challenges of rare disease development, including small populations, site selection, natural history, endpoint selection, and patient engagement.
• Excellent communication and influence skills, with the ability to synthesize complex issues for senior leaders and governance bodies.

Benefits

• premium health
• financial, work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off