VP, Global Clinical Development & Program Strategy

Madrigal Pharmaceuticals Italia; Conshohocken (Montgomery County); On-site; USD 350,000 - 650,000; Full time

Benefits offered by this job

Equity ownership

Comprehensive benefits

Flexible paid time off

Job summary

Madrigal Pharmaceuticals is seeking a Vice President, Clinical Development Program Leader to shape and execute clinical strategy across therapeutic programs. This senior leader will oversee from preclinical through late-stage development, ensuring scientific rigor, patient safety, and alignment with corporate priorities.

The VP will build and guide cross‑functional teams, drive CDP development, and manage regulatory interactions with global agencies to enable successful IND/NDAs/BLAs filings and

Qualifications

• MD or DO; board certification in Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field preferred.
• 10–15+ years of clinical development experience, including leadership of early‑phase and late‑stage programs, with 20+ years 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.

Responsibilities

• Lead cross‑functional program teams, shaping 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 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.
• Develop clinical and translational strategy for new assets, including TPP definition and indication prioritization.
• Lead creation of CDPs from FIH through PoC and late‑stage trials.
• Oversee design and medical oversight of FIH, SAD/MAD, translational, and PoC studies, and Phase I–IV trials.
• Ensure high‑quality medical monitoring, patient safety oversight, and timely decision‑making.
• Lead early regulatory interactions (pre‑IND, Scientific Advice, ITF meetings) and respond to regulatory feedback.
• Oversee IND submissions, Investigator Brochures, and regulatory documentation quality.
• Represent Madrigal in global regulatory interactions (FDA, EMA, PMDA).
• Support regulatory submissions planning and defense, including amendments and marketing applications.
• Collaborate with Translational Medicine, Nonclinical, CMC, Regulatory, and Safety functions.

Skills

MD/DO

Clinical development leadership

IND/NDAs/BLAs

Translational medicine

PK/PD

Regulatory strategy

Global matrixed teams

Biopharma experience

Education

MD/DO with board certification

Job description

Madrigal Pharmaceuticals is seeking a Vice President, Clinical Development Program Leader to shape and execute clinical strategy across therapeutic programs. This senior leader will oversee from preclinical through late-stage development, ensuring scientific rigor, patient safety, and alignment with corporate priorities.

The VP will build and guide cross‑functional teams, drive CDP development, and manage regulatory interactions with global agencies to enable successful IND/NDAs/BLAs filings and