Senior Medical Director, Clinical Development, Endocrinology/CAH

Role Summary

The Senior Medical Director, Clinical Development will serve as the medical and scientific leader for clinical development programs in congenital adrenal hyperplasia (CAH) and other new and emerging programs in endocrinology. This role provides end-to-end medical leadership across late-stage clinical development while also shaping early clinical strategies to support lifecycle expansion.

Responsibilities

• Serves as the Program/Therapeutic Medical Lead in endocrinology/CAH, providing medical leadership and accountability for clinical development strategy and execution
• Defines and drives integrated clinical development plans supporting late-stage development, regulatory filings, and post-approval commitments
• Leads clinical strategy for early-stage evaluation of new and emerging indications related to CAH and adrenal/endocrine disorders
• Provides medical leadership to cross-functional Program Teams, ensuring alignment of clinical strategy with scientific rationale, regulatory expectations, and business objectives
• Accountable for clinical trial design across Phase 1–3 studies, including development of study synopses, protocols, major amendments, and clinical study reports
• Oversees data collection strategies and leads interpretation of clinical efficacy, safety, and biomarker data
• Partners with Clinical Operations to oversee execution of clinical trials in accordance with GCP and applicable global regulations
• Conducts medical review and disposition of adverse events in collaboration with Drug Safety, maintaining ongoing assessment of benefit–risk across the program
• Provides clinical leadership for interactions with global regulatory authorities and supports preparation of INDs, NDAs, sNDAs, and other regulatory submissions
• Contributes to labeling strategy, pediatric development planning, and lifecycle management activities
• Anticipates regulatory and clinical risks and proactively develops mitigation strategies
• Leads analysis, interpretation, and communication of clinical study results to internal stakeholders, investigators, and external audiences
• Provides strategic direction for scientific disclosures, including congress presentations, abstracts, and peer-reviewed publications
• Engages with key opinion leaders, investigators, advocacy groups, and external experts to inform strategy and support development objectives
• Partners with Medical Affairs to support scientific exchange and data dissemination
• Collaborates with Research and Translational Medicine to define and implement biomarker strategies that inform dose selection, patient stratification, and early proof-of-concept in CAH and new indications
• Integrates mechanistic understanding of disease biology into clinical development decisions
• Interfaces with Research, Business Development, and Product Development to assess new clinical opportunities and shape early development strategies
• Identifies clinical resource needs and contributes to budget planning and forecasting
• Plays a key role in recruiting, mentoring, and developing clinical team members and in selecting and managing external consultants and CRO partners
• Contributes to the development and continuous improvement of clinical development processes and best practices

Qualifications

• Minimum of 4+ years of experience in clinical development within the biopharmaceutical and/or CRO industry (Required)
• Deep expertise in endocrinology, rare disease development, and/or adrenal disorders
• Demonstrated success leading late-stage clinical programs and contributing to regulatory filings (INDs, NDAs, sNDAs)
• Experience developing early-stage clinical strategies for new indications or lifecycle expansion
• Strong understanding of translational medicine, biomarker development, study design, biostatistics, and data interpretation
• Proven ability to lead cross-functional, matrixed teams and manage external CROs and vendors
• Strong knowledge of GCP, regulatory requirements, and global drug development processes
• Strategic, science-driven leader with the ability to translate complex clinical strategy into executable development plans
• Strong mentoring and people leadership skills, with experience leading direct and indirect teams
• Exceptional collaboration and influence skills across functions and with external stakeholders
• Outstanding oral and written communication skills, with the ability to clearly articulate complex clinical and scientific concepts
• Highly adaptable, self-motivated, and capable of managing multiple priorities in a fast-paced environment
• Demonstrated project management skills and attention to detail
• Proficiency with standard business and clinical documentation tools

Education

• MD or DO (or equivalent) in Endocrinology or a related clinical specialty
• Accredited residency training required; fellowship training in Endocrinology and board certification strongly preferred

Skills

• Strategic, science-driven leadership and the ability to translate clinical strategy into executable development plans
• Mentoring and people leadership skills
• Cross-functional collaboration and influence across internal teams and external stakeholders
• Excellent oral and written communication skills
• Adaptability and the ability to manage multiple priorities in a fast-paced environment
• Project management and attention to detail
• Proficiency with standard business and clinical documentation tools