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 of Pharmaceutical Science 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, etc. It will provide strategic oversight of all Pharmaceutical Sciences activities at Madrigal, with emphasis on Drug Product Formulations that ensure drug safety studies and clinical trials are supported with appropriate quality IMP in a timely manner.

Responsibilities

• Strategic oversight for all drug product teams and their activities from API Final Form selection, development of preclinical formulations, definition and development of fit-for-purpose formulations to support early clinical development through definition of robust commercial formulations that meet the Target Patient Profile.
• Oversee all aspects of the lifecycle of formulation development including drug product definition, process development and characterization, DOE and robustness studies through to partnering with MS&T for successful process validation
• Partner with the Executive Director of Organic Chemistry in the generation, evaluation, selection and development of final API forms.
• Provide strategic guidance to enable empowered CMC and Pharmaceutical Science teams to define stage-appropriate processes and control strategies that are Fit for Purpose for stage of development
• Ensure that syntheses align with the company’s Quality, Regulatory, and Supply Chain standards
• Insure development of robust, scalable and cost-effective formulations and drug product processes for commercial manufacture
• Implement Quality-by-Design (QbD) and Quality Risk Management (QRM) principles throughout the development lifecycle
• Development of timely budget submissions that insure achievement of all project team goals for formulation needs
• Drive innovation in partnership with the Manufacturing Science and Technology team to enhance product robustness, supply resilience, and cost efficiency
• Define and deliver a Fit-for-Purpose Pharmaceutical Science organization that balances internal and external resources to deliver on all Drug Product objectives in a timely and cost-efficient manner
• Collaborate with Global Procurement to define CROs and CMOs that can define products & processes for CMC teams and deliver formulations with systems and processes in compliance with regulatory standards
• Through CROs and CDMOs, execute plans for the validation and registration of formulations as required by cGMP, ICH and FDA regulations
• Insure Intellectual Property Coverage to enhance pipeline value and Freedom to Operate
• Provide direction and oversight of the authoring and reviewing of Pharmaceutical Science documents for INDs, NDAs and other regulatory submissions
• Review and author CMC regulatory and Quality documents as required
• Review Quality Agreements, participate in audit programs, and ensure risk-based CMC oversight for all 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’s 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 in working with CROs and CMOs and driving technical solutions in an external environment
• Demonstrated success in 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
• Strategic and operational leader with a balance of scientific depth and business acumen
• Strong leadership skills with an ability to influence and empower
• Strong technical expertise in Pharmaceutical Science, development, processes and technologies
• Excellent problem-solving and risk management skills to address complex issues
• Strong written and verbal communication and interpersonal skills with the ability to collaborate across functions, external partners, and present to executive stakeholders
• Detail-oriented with a focus on maintaining high standards of quality and compliance
• Proactive and strategic thinker with an empowering approach to solving technical challenges
• Aptitude for identifying inefficiencies and driving process improvements within CMC, SC, and QA
• Mentorship ability to develop others in quality and best practices

Education

• PhD degree in Pharmaceutical or Material Sciences, Organic or Inorganic or Analytical or Polymer Chemistry or Master’s Degree with relevant development and leadership experience