Vice President, Clinical Development Program Leader (MD)

About the role

The Vice President, Clinical Development Program Leader is a senior clinical leader responsible for shaping, leading, and executing clinical strategy across one or more therapeutic programs. This role blends strategic clinical leadership, cross-functional program oversight, and hands-on execution from early development through registration.

Responsibilities

• Lead cross-functional program teams, shaping product strategy and driving integrated development plans.
• Transition from direct clinical oversight in early development to strategic leadership of a growing clinical team.
• Set program goals in collaboration with executive leadership, ensuring alignment across functions.
• Maintain accountability for program timelines, budget, and deliverables, aligning activities with portfolio management and internal reporting needs.
• Develop clinical and translational strategy for new assets, including Target Product Profile (TPP) definition, clinical hypotheses, and 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, and PoC studies, as well as Phase I–IV trials.
• Ensure high-quality medical monitoring, patient safety oversight, and timely clinical decision-making.
• Lead early regulatory interactions (pre-IND, Scientific Advice, ITF meetings) and respond to regulatory feedback.
• Oversee development and medical accuracy of IND submissions, Investigator Brochures, and regulatory documentation.
• Serve as senior clinical representative in global regulatory interactions (FDA, EMA, PMDA, etc.).
• Support preparation and defense of regulatory submissions, including IND amendments, meeting packages, and marketing applications.
• Integrate clinical development, biostatistics, operations, CMC, regulatory, and safety functions for assigned programs.
• Partner with Translational Medicine, Nonclinical, CMC, Commercial, and Market Access teams to shape biomarker development, assay readiness, and patient stratification strategies.
• Foster robust cross-functional collaboration, scenario planning, and contingency strategies.
• Build and maintain relationships with KOLs, investigators, scientific advisors, and development partners.
• Represent Madrigal at scientific meetings, advisory boards, and collaborative consortia.
• Support scientific publication and external communication strategies.
• Mentor and guide clinical scientists and cross-functional team members.
• Contribute to building early-development capabilities, frameworks, processes, and scalable best practices.
• Foster a culture of openness, trust, and scientific integrity.

Requirements

• MD or DO; board certification in a relevant specialty (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field) preferred.
• 10–15+ years of clinical development experience, including significant leadership of early-phase and late-stage programs, with 20+ years of total relevant experience.
• Proven success in leading clinical programs across all development phases, including regulatory filings (INDs/NDAs/BLAs), launch, and commercialization.
• Strong background in translational medicine, biomarkers, and early-phase PK/PD.
• Demonstrated success leading pre-IND and IND interactions with global regulatory agencies.
• Extensive experience working in matrixed, global teams, with the ability to influence across functions without direct reporting lines.
• Deep understanding of the commercial landscape, regulatory strategy, and CMC considerations relevant to drug development.

Qualifications

• Strategic clinical leadership and ability to create strategy from incomplete data.
• Translational and hypothesis-driven thinking.
• Cross-functional integration and collaboration.
• Scientific rigor and disciplined decision-making.
• Organizational leadership and talent development.
• External engagement and influence.
• Strong clinical judgment, communication, and ethical conduct.

Skills

• Strategic clinical leadership.
• Translational and hypothesis-driven thinking.
• Cross-functional integration and collaboration.
• Scientific rigor and disciplined decision-making.
• Organizational leadership and talent development.
• External engagement and influence.
• Strong clinical judgment, communication, and ethical conduct.

Benefits

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $378,000 - $462,000 per year. We comply with all applicable minimum wage laws. All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.

Pay

As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $378,000 - $462,000 per year.

Schedule

Not specified.