Vice President, Clinical Development Program Leader (MD)
Madrigal Pharmaceuticals
15 days ago
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Role Overview:
Vice President, Clinical Development Program Leader responsible for shaping, leading, and executing clinical strategy across one or more therapeutic programs from early development through registration.
Key Responsibilities:
- Lead cross-functional program teams; shape product strategy and integrated development plans.
- Transition from direct clinical oversight in early development to strategic leadership of a growing clinical team.
- Set program goals with executive leadership; ensure alignment across functions.
- Own program timelines, budget, and deliverables; align with portfolio management and internal reporting.
- Develop clinical and translational strategy (TPP definition, clinical hypotheses, indication prioritization).
- Lead creation of Clinical Development Plans (CDPs) from FIH through Proof-of-Concept (PoC) and late-stage trials.
- Oversee design and medical oversight of FIH, SAD/MAD, translational, PoC, and Phase I–IV trials.
- Ensure medical monitoring quality, patient safety oversight, and timely clinical decisions.
- Lead early regulatory interactions (pre-IND, Scientific Advice, ITF); respond to regulatory feedback.
- Oversee IND submission content accuracy (INDs, Investigator Brochures, regulatory documentation).
- Serve as senior clinical representative in global regulatory interactions (FDA, EMA, PMDA, etc.);
- Support preparation and defense of regulatory submissions (IND amendments, meeting packages, marketing applications).
- Integrate cross-functional input (clinical, biostatistics, operations, CMC, regulatory, safety) and partner on biomarker development/assay readiness/patient stratification.
- Build KOL/investigator relationships; represent the company at meetings and support publications.
- Mentor team members; build scalable early-development capabilities.
Required & Desired Qualifications:
- MD or DO; board certification preferred (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related).
- 10–15+ years clinical development leadership; 20+ years total relevant experience.
- Proven success leading programs across all phases, including regulatory filings and commercialization.
- Strong translational medicine, biomarkers, and early-phase PK/PD.
- Demonstrated success with pre-IND and IND interactions with global regulators.
- Extensive matrix/global team experience; influence without direct reporting lines.
- Deep understanding of commercial/regulatory strategy and CMC considerations.
Competencies:
- Strategic leadership; hypothesis-driven thinking; cross-functional integration.
- Scientific rigor, disciplined decision-making, talent development.
- External engagement, strong clinical judgment, communication, and ethical conduct.
Application:
Submit via the Madrigal Careers site.
Vice President, Clinical Development Program Leader responsible for shaping, leading, and executing clinical strategy across one or more therapeutic programs from early development through registration.
Key Responsibilities:
- Lead cross-functional program teams; shape product strategy and integrated development plans.
- Transition from direct clinical oversight in early development to strategic leadership of a growing clinical team.
- Set program goals with executive leadership; ensure alignment across functions.
- Own program timelines, budget, and deliverables; align with portfolio management and internal reporting.
- Develop clinical and translational strategy (TPP definition, clinical hypotheses, indication prioritization).
- Lead creation of Clinical Development Plans (CDPs) from FIH through Proof-of-Concept (PoC) and late-stage trials.
- Oversee design and medical oversight of FIH, SAD/MAD, translational, PoC, and Phase I–IV trials.
- Ensure medical monitoring quality, patient safety oversight, and timely clinical decisions.
- Lead early regulatory interactions (pre-IND, Scientific Advice, ITF); respond to regulatory feedback.
- Oversee IND submission content accuracy (INDs, Investigator Brochures, regulatory documentation).
- Serve as senior clinical representative in global regulatory interactions (FDA, EMA, PMDA, etc.);
- Support preparation and defense of regulatory submissions (IND amendments, meeting packages, marketing applications).
- Integrate cross-functional input (clinical, biostatistics, operations, CMC, regulatory, safety) and partner on biomarker development/assay readiness/patient stratification.
- Build KOL/investigator relationships; represent the company at meetings and support publications.
- Mentor team members; build scalable early-development capabilities.
Required & Desired Qualifications:
- MD or DO; board certification preferred (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related).
- 10–15+ years clinical development leadership; 20+ years total relevant experience.
- Proven success leading programs across all phases, including regulatory filings and commercialization.
- Strong translational medicine, biomarkers, and early-phase PK/PD.
- Demonstrated success with pre-IND and IND interactions with global regulators.
- Extensive matrix/global team experience; influence without direct reporting lines.
- Deep understanding of commercial/regulatory strategy and CMC considerations.
Competencies:
- Strategic leadership; hypothesis-driven thinking; cross-functional integration.
- Scientific rigor, disciplined decision-making, talent development.
- External engagement, strong clinical judgment, communication, and ethical conduct.
Application:
Submit via the Madrigal Careers site.