Senior Medical Director, Clinical Development, Endocrinology/CAH
Neurocrine Biosciences
10 hours ago
Remote friendly (San Diego, CA)
United States
$301,100 - $411,000 USD yearly
Clinical Research and Development
About The Role
- 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 endocrinology programs.
- Provides end-to-end medical leadership across late-stage clinical development and shapes early clinical strategies to support lifecycle expansion.
- As Program/Therapeutic Medical Lead, defines and executes clinical development strategies across Phase 1–3 studies with cross-functional partners (Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety, Translational Medicine, Medical Affairs, Research).
Your Contributions (include, But Are Not Limited To)
Clinical & Program Leadership
- Serve as Program/Therapeutic Medical Lead in endocrinology/CAH; provide medical leadership and accountability for strategy and execution.
- Define and drive integrated clinical development plans for late-stage development, regulatory filings, and post-approval commitments.
- Lead clinical strategy for early-stage evaluation of new/emerging indications related to CAH and adrenal/endocrine disorders.
- Provide medical leadership to cross-functional Program Teams to align clinical strategy with scientific rationale, regulatory expectations, and business objectives.
Study Design, Execution & Oversight
- Accountable for clinical trial design across Phase 1–3 (synopses, protocols, major amendments, clinical study reports).
- Oversee data collection strategies and interpret clinical efficacy, safety, and biomarker data.
- Partner with Clinical Operations to oversee trial execution in line with NBI SOPs, GCP, and applicable global regulations.
- Perform medical review and adverse event disposition with Drug Safety; maintain ongoing benefit–risk assessment.
Regulatory & Lifecycle Strategy
- Provide clinical leadership for interactions with global regulatory authorities; support preparation of INDs, NDAs, sNDAs, and other regulatory submissions.
- Contribute to labeling strategy, pediatric development planning, and lifecycle management.
- Anticipate regulatory/clinical risks and develop mitigation strategies.
Scientific Communication & External Engagement
- Lead analysis, interpretation, and communication of clinical study results to internal stakeholders, investigators, and external audiences.
- Direct scientific disclosures (congress presentations, abstracts, peer-reviewed publications).
- Engage key opinion leaders, investigators, advocacy groups, and external experts to inform strategy and support development objectives.
- Partner with Medical Affairs to support scientific exchange and data dissemination.
Translational Medicine & Biomarkers
- Collaborate with Research and Translational Medicine to define biomarker strategies for dose selection, patient stratification, and early proof-of-concept in CAH and new indications.
- Integrate mechanistic disease biology into clinical development decisions.
Portfolio & Organizational Leadership
- Interface with Research, Business Development, and Product Development to assess new clinical opportunities and shape early development strategies.
- Identify clinical resource needs; contribute to budget planning and forecasting.
- Recruit, mentor, develop clinical team members; select and manage external consultants and CRO partners.
- Contribute to development and continuous improvement of clinical development processes and best practices.
Requirements
Education & Training
- MD or DO (or equivalent) in Endocrinology or related clinical specialty.
- Accredited residency training required; fellowship training in Endocrinology and board certification strongly preferred.
- Minimum 4+ years of experience in clinical development in the biopharmaceutical and/or CRO industry.
Experience & Expertise
- 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; manage external CROs and vendors.
- Strong knowledge of GCP, regulatory requirements, and global drug development processes.
Leadership & Core Competencies
- Strategic, science-driven leader who can translate complex clinical strategy into executable development plans.
- Strong mentoring and people leadership skills (direct and indirect teams).
- Exceptional collaboration and influence across functions and external stakeholders.
- Outstanding oral and written communication skills.
- Highly adaptable, self-motivated; manages multiple priorities in a fast-paced environment.
- Demonstrated project management skills and attention to detail.
- Proficiency with standard business and clinical documentation tools.
Benefits (explicitly stated)
- Annual bonus with target of 35% of earned base salary; eligibility for equity-based long-term incentive program.
- Retirement savings plan (with company match), paid vacation/holidays/personal days.
- Paid caregiver/parental and medical leave.
- Health benefits: medical, prescription drug, dental, and vision coverage (per plan terms).
- 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 endocrinology programs.
- Provides end-to-end medical leadership across late-stage clinical development and shapes early clinical strategies to support lifecycle expansion.
- As Program/Therapeutic Medical Lead, defines and executes clinical development strategies across Phase 1–3 studies with cross-functional partners (Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety, Translational Medicine, Medical Affairs, Research).
Your Contributions (include, But Are Not Limited To)
Clinical & Program Leadership
- Serve as Program/Therapeutic Medical Lead in endocrinology/CAH; provide medical leadership and accountability for strategy and execution.
- Define and drive integrated clinical development plans for late-stage development, regulatory filings, and post-approval commitments.
- Lead clinical strategy for early-stage evaluation of new/emerging indications related to CAH and adrenal/endocrine disorders.
- Provide medical leadership to cross-functional Program Teams to align clinical strategy with scientific rationale, regulatory expectations, and business objectives.
Study Design, Execution & Oversight
- Accountable for clinical trial design across Phase 1–3 (synopses, protocols, major amendments, clinical study reports).
- Oversee data collection strategies and interpret clinical efficacy, safety, and biomarker data.
- Partner with Clinical Operations to oversee trial execution in line with NBI SOPs, GCP, and applicable global regulations.
- Perform medical review and adverse event disposition with Drug Safety; maintain ongoing benefit–risk assessment.
Regulatory & Lifecycle Strategy
- Provide clinical leadership for interactions with global regulatory authorities; support preparation of INDs, NDAs, sNDAs, and other regulatory submissions.
- Contribute to labeling strategy, pediatric development planning, and lifecycle management.
- Anticipate regulatory/clinical risks and develop mitigation strategies.
Scientific Communication & External Engagement
- Lead analysis, interpretation, and communication of clinical study results to internal stakeholders, investigators, and external audiences.
- Direct scientific disclosures (congress presentations, abstracts, peer-reviewed publications).
- Engage key opinion leaders, investigators, advocacy groups, and external experts to inform strategy and support development objectives.
- Partner with Medical Affairs to support scientific exchange and data dissemination.
Translational Medicine & Biomarkers
- Collaborate with Research and Translational Medicine to define biomarker strategies for dose selection, patient stratification, and early proof-of-concept in CAH and new indications.
- Integrate mechanistic disease biology into clinical development decisions.
Portfolio & Organizational Leadership
- Interface with Research, Business Development, and Product Development to assess new clinical opportunities and shape early development strategies.
- Identify clinical resource needs; contribute to budget planning and forecasting.
- Recruit, mentor, develop clinical team members; select and manage external consultants and CRO partners.
- Contribute to development and continuous improvement of clinical development processes and best practices.
Requirements
Education & Training
- MD or DO (or equivalent) in Endocrinology or related clinical specialty.
- Accredited residency training required; fellowship training in Endocrinology and board certification strongly preferred.
- Minimum 4+ years of experience in clinical development in the biopharmaceutical and/or CRO industry.
Experience & Expertise
- 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; manage external CROs and vendors.
- Strong knowledge of GCP, regulatory requirements, and global drug development processes.
Leadership & Core Competencies
- Strategic, science-driven leader who can translate complex clinical strategy into executable development plans.
- Strong mentoring and people leadership skills (direct and indirect teams).
- Exceptional collaboration and influence across functions and external stakeholders.
- Outstanding oral and written communication skills.
- Highly adaptable, self-motivated; manages multiple priorities in a fast-paced environment.
- Demonstrated project management skills and attention to detail.
- Proficiency with standard business and clinical documentation tools.
Benefits (explicitly stated)
- Annual bonus with target of 35% of earned base salary; eligibility for equity-based long-term incentive program.
- Retirement savings plan (with company match), paid vacation/holidays/personal days.
- Paid caregiver/parental and medical leave.
- Health benefits: medical, prescription drug, dental, and vision coverage (per plan terms).