Senior Director, Clinical Development (MD)
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Senior Director, Clinical Development
Responsibilities
- Provide strategic clinical leadership across 3 clinical-stage programs and 17 active studies.
- Lead integrated Clinical Development Plans (CDPs) from early development through registration and lifecycle management.
- Set development milestones, go/no-go criteria, and risk mitigation strategies.
- Serve as the medical voice at governance and executive meetings.
- Lead Phase I–III trial design and medical oversight (FIH, PoC, registrational, outcomes).
- Define endpoints, biomarker strategies, patient populations, statistical assumptions, and differentiation strategies.
- Integrate translational/PK-PD/biomarker data into dosing and clinical decision-making.
- Provide medical oversight for patient safety, data integrity, and trial execution; partner with Clinical Ops on enrollment and issue resolution.
- Perform benefit–risk assessments, guide adaptive strategies, and support safety governance/data monitoring.
- Lead global regulatory interactions (FDA/EMA/health authorities) and oversee INDs/amendments/briefing books/IBs/CSRs/NDA-MAA submissions.
- Collaborate with Translational Medicine, Nonclinical, CMC, Biometrics, Commercial, and HEOR.
Required Qualifications
- MD or MD/PhD; board certification in a relevant specialty.
- 10+ years clinical development; 15+ total relevant experience.
- Demonstrated success with health authority interactions.
- Proven ability to design trials and make benefit-risk decisions with limited data.
- Strong leadership and stakeholder influence.
Preferred Qualifications
- Experience in liver disease/MASH-NASH/metabolic disorders/inflammation/endocrine pathways.
- Experience supporting/leading NDA/MAA submissions and/or outcomes studies.
- Experience advancing programs from early development through registration.
Benefits
- Competitive Total Rewards including base pay, bonus, equity, and comprehensive benefits (flexible PTO; medical/dental/vision; life/disability; 401(k)); additional voluntary benefits; mental health support via EAP.
Compensation
- Estimated base salary: $330,000–$403,000/year.
Application Instructions
- Apply via the Madrigal Careers site (accepted on an ongoing basis).
Responsibilities
- Provide strategic clinical leadership across 3 clinical-stage programs and 17 active studies.
- Lead integrated Clinical Development Plans (CDPs) from early development through registration and lifecycle management.
- Set development milestones, go/no-go criteria, and risk mitigation strategies.
- Serve as the medical voice at governance and executive meetings.
- Lead Phase I–III trial design and medical oversight (FIH, PoC, registrational, outcomes).
- Define endpoints, biomarker strategies, patient populations, statistical assumptions, and differentiation strategies.
- Integrate translational/PK-PD/biomarker data into dosing and clinical decision-making.
- Provide medical oversight for patient safety, data integrity, and trial execution; partner with Clinical Ops on enrollment and issue resolution.
- Perform benefit–risk assessments, guide adaptive strategies, and support safety governance/data monitoring.
- Lead global regulatory interactions (FDA/EMA/health authorities) and oversee INDs/amendments/briefing books/IBs/CSRs/NDA-MAA submissions.
- Collaborate with Translational Medicine, Nonclinical, CMC, Biometrics, Commercial, and HEOR.
Required Qualifications
- MD or MD/PhD; board certification in a relevant specialty.
- 10+ years clinical development; 15+ total relevant experience.
- Demonstrated success with health authority interactions.
- Proven ability to design trials and make benefit-risk decisions with limited data.
- Strong leadership and stakeholder influence.
Preferred Qualifications
- Experience in liver disease/MASH-NASH/metabolic disorders/inflammation/endocrine pathways.
- Experience supporting/leading NDA/MAA submissions and/or outcomes studies.
- Experience advancing programs from early development through registration.
Benefits
- Competitive Total Rewards including base pay, bonus, equity, and comprehensive benefits (flexible PTO; medical/dental/vision; life/disability; 401(k)); additional voluntary benefits; mental health support via EAP.
Compensation
- Estimated base salary: $330,000–$403,000/year.
Application Instructions
- Apply via the Madrigal Careers site (accepted on an ongoing basis).