Executive Director, Pharmaceutical Science

Role Summary

The Executive Director of Pharmaceutical Science is a senior leadership role dedicated to supporting the CMC development of drug candidate molecules of any modality, primarily small molecule, from preclinical development through process validation and regulatory approval. The Executive Director will serve as a key member of the CMC executive leadership team, responsible for building and leading the company’s CMC strategy across pre-clinical and clinical development, scale-up, and commercialization. This role requires a highly collaborative individual that establishes excellent relationships with Quality, Research, Regulatory Affairs, Drug Safety, Clinical, Supply Chain, external partners, and others. The position oversees all Pharmaceutical Sciences activities at Madrigal, with emphasis on Drug Product Formulations to ensure safety studies and clinical trials are supported with appropriate quality IMP in a timely manner.

Responsibilities

• Strategic oversight for all drug product teams from API final form selection to development of formulations for early clinical development and robust commercial formulations.
• Oversee the lifecycle of formulation development including drug product definition, process development and characterization, DOE and robustness studies, and coordination with MS&T for process validation.
• Collaborate with the Executive Director of Organic Chemistry on final API form generation, evaluation, and development.
• Provide strategic guidance to enable empowered CMC and Pharmaceutical Science teams with stage-appropriate processes and control strategies.
• Ensure syntheses align with Quality, Regulatory, and Supply Chain standards.
• Develop robust, scalable, and cost-effective formulations and drug product processes for commercial manufacture.
• Implement Quality-by-Design and Quality Risk Management throughout the development lifecycle.
• Prepare timely budget submissions to meet project goals for formulation needs.
• Drive innovation with Manufacturing Science and Technology to enhance product robustness, supply resilience, and cost efficiency.
• Define and deliver a Fit for Purpose Pharmaceutical Science organization balancing internal and external resources.
• Collaborate with Global Procurement to define CROs and CMOs that ensure regulatory compliance in products and processes.
• Execute plans for validation and registration of formulations through CROs/CDMOs in line with cGMP, ICH, and FDA regulations.
• Obtain Intellectual Property coverage to enhance pipeline value and Freedom to Operate.
• Direct authoring and review of Pharmaceutical Science documents for INDs, NDAs, and other regulatory submissions.
• Review CMC regulatory and Quality documents as required; review Quality Agreements and participate in audit programs; maintain risk-based CMC oversight for external partners.
• Champion a culture of Right First Time, data integrity, and continuous improvement across CMC and technical operations.
• Collaborate with Quality Assurance to support inspection readiness and represent the company as an API/CMC subject matter expert during regulatory inspections and audits.

Qualifications

• PhD degree in Pharmaceutical or Material Sciences, Organic or Inorganic or Analytical or Polymer Chemistry or a Master‚Äôs Degree with commensurate Pharmaceutical Science development and leadership experience.
• Minimum of 10 years of experience in Pharmaceutical Science and CMC leadership within the biopharmaceutical industry, with a strong background in CMC and Drug Product development.
• Proven experience working with CROs and CMOs and driving technical solutions in an external environment.
• Demonstrated success transitioning programs from clinical development to commercial manufacturing, including process validation and regulatory approval.
• Strong knowledge of cGMP and ICH guidelines and global regulatory requirements.

Skills

• Strategic and operational leadership with a balance of scientific depth and business acumen.
• Strong leadership abilities to influence and empower teams.
• Technical expertise in Pharmaceutical Science, development processes, and technologies.
• Excellent problem-solving and risk management capabilities.
• Strong written and verbal communication and interpersonal skills for collaboration across functions, external partners, and executive presentation.

Education

• PhD in a relevant field or Master‚Äôs Degree with substantial Pharmaceutical Science leadership experience.

Additional Requirements

• Experience with CROs/CDMOs and external collaborations; familiarity with regulatory submissions and inspections.
• Ability to mentor others in quality and best practices; proactive, detail-oriented, and quality-focused mindset.