Director, Drug Product Small Molecule SME

Madrigal Pharmaceuticals Inc.; Conshohocken (Montgomery County); Hybride; USD 204 000 - 250 000; Plein temps

Avantages offerts par ce poste

Equity

Comprehensive benefits

Flexible PTO

401(k) with employer match

Résumé du poste

Madrigal Pharmaceuticals Inc. is seeking a Director Drug Product SME to lead the CMC drug product development strategy for our small molecule portfolio.

This role directs formulation and process development across preclinical to clinical stages, ensuring robust data packages and timely clinical supply readiness. The ideal candidate will drive cross-functional collaboration with Quality, Regulatory, and External partners, mentor a high-performing team, and shape strategy for scalable, compliant

Qualifications

• Minimum 12 years of Pharmaceutical Science and CMC development experience.
• Proven leadership in small molecule drug product formulation/processing.
• Experience leading CDMO/CRO programs in outsourced paradigm with external partners.
• Experience onboarding assets post-acquisition is desirable.
• Demonstrated statistical DOE strategy and risk assessment leadership.
• Strong knowledge of cGMP & ICH guidelines; regulatory document authoring experience.
• Ability to coach and develop technical talent.

Responsabilités

• Lead preclinical to clinical development of small-molecule formulations and processes.
• Ensure readiness for clinical supply manufacture and scale-up.
• Oversee CDMO/CRO relationships and vendor performance.
• Drive Quality-by-Design and risk management across lifecycle.
• Mentor and develop a high-performing CMC team.

Connaissances

Strategic leadership

Cross-functional leadership

CMC expertise

Data-driven decisions

Regulatory collaboration

Formation

PhD in Pharmaceutics/Chemistry/Materials

Description du poste

Position Summary

The Director Drug Product SME is an experienced scientific and technical leader, accountable for defining and driving the CMC drug product development strategy for Madrigal’s small molecule portfolio. This role leads drug product formulation and process development, ensuring preclinical and clinical studies are supported with phase‑appropriate quality investigational medicinal product, delivered on time and guided by scientific rigor, risk assessment and data‑driven decision‑making. The Director is accountable for leading at least one cross‑functional CMC team and driving strategic and technical decisions supporting the development of a clinical‑stage asset. As a key member of CMC development project teams within Technical Operations, this leader is also expected to serve, where assigned, as a program‑level CMC lead across preclinical development, clinical development, scale‑up, registration, and commercialization.

This role owns drug product development deliverables by defining and translating drug product strategy into protocols, data packages, and external partner deliverables. Responsibilities include directing technical evaluation and selection of formulation and processing options, leading resolution of drug product technical challenges, and ensuring readiness and accountable oversight for clinical supply manufacture. The Director will lead the generation and approval of high‑quality reports and documentation inputs that support CMC authoring, regulatory traceability, and program decision‑making. This role requires strong cross‑functional leadership with Quality, Research, Regulatory Affairs, Drug Safety, Clinical, and Supply Chain teams, as well as accountable oversight of external CDMO and CRO relationships supporting candidate development across all phases. Ultimately, the ideal candidate is a collaborative technical leader, with expertise in small molecule modalities, who can develop, mentor, and strengthen a high‑performing team supporting the development of an industry‑leading MASH‑focused pipeline.

Key Responsibilities

Drug Product Development and Technical Strategy

• Lead the generation, critical assessment, and strategic application of comprehensive pre‑formulation data packages and asset profiles to drive developability assessment, development strategy, and program planning.
• Lead and be accountable for phase‑appropriate development, optimization, and delivery of small‑molecule formulations, associated processes, and material supply from preclinical through clinical development.
• Define and lead formulation and process development strategies to address bioavailability risks and enable fixed‑dose combination development with Rezdiffra® (resmetirom), where applicable.
• Lead drug product registration readiness, final scale‑up, process validation, and commercial presentation development in accordance with cGMP, ICH, FDA, and internal target product profile requirements.

External Partner and CDMO Oversight

• Serve as the primary drug product technical lead and accountable contact for CDMOs, directing performance and overseeing key deliverables, including protocols, batch records, reports, investigations, and technical documentation.
• Lead investigation and resolution of complex drug product issues, establish root‑cause hypotheses and corrective strategies, and drive timely resolution with cross‑functional internal and external partners.
• Lead drug product technology transfer strategy and readiness, including process descriptions, control strategies, sampling plans, comparability considerations, and transfer documentation.
• Partner with leadership and Global Procurement to define, evaluate, and maintain a CDMO/CRO network that meets current and future CMC business, regulatory, and quality needs; provide technical leadership in partner selection and performance management.

Quality, Regulatory, and CMC Documentation

• Drive implementation of Quality‑by‑Design and Quality Risk Management principles throughout the development lifecycle, ensuring clear decision logs, assumptions, data traceability, and alignment with Quality, Regulatory, and Supply Chain standards. Establish and lead sound decision‑making processes grounded in scientific rigor and robust data, leveraging cross‑functional expertise.
• Champion and direct the use of statistical design‑of‑experiment practices and AI‑enabled tools to increase efficiency and effectiveness in generating CMC knowledge and phase‑appropriate control strategies.
• Lead authoring, compilation, critical review, and approval, as appropriate, of drug product technical reports, regulatory source data, CMC regulatory documents, and quality documentation as required.
• Provide drug product technical leadership in reviewing quality agreements, leading technical contributions to audit programs, maintaining inspection readiness, and representing the company as a CMC subject matter expert in regulatory inspections and audits as required.

Cross‑Functional Leadership and Operational Excellence

• Lead cross‑functional alignment and decision‑making across Technical Operations, MSAT, Quality, Research, Regulatory Affairs, Drug Safety, Clinical, Supply Chain, and other stakeholders throughout all stages of development.
• Drive early development collaboration with MSAT to establish future product robustness, supply resilience, and cost efficiency.
• Own development, submission, monitoring, and management of fiscally responsible project budgets aligned with phase‑appropriate and risk‑tolerant project goals.
• Lead and champion a Right‑First‑Time culture focused on data integrity, scientific rigor, continuous improvement, and operational excellence across CMC and Technical Operations.

Qualifications and Skills Required

Education:

• PhD degree in Pharmaceutics, Chemistry or Material Sciences, or BS/MS degree and commensurate Pharmaceutical Science development and leadership experience

Experience:

• Minimum of 12 years of experience in Pharmaceutical Science and CMC development within the biopharmaceutical industry, including demonstrated technical leadership and accountability for Drug Product development programs.
• Proven track record of leading small molecule drug product formulation/process development strategies, technical decisions, and stage‑appropriate deliverables.
• Proven experience leading CDMO/CRO technical programs in a fully outsourced paradigm, with accountability for development and clinical supply manufacture, partner performance, and delivery of complex technical solutions in an external environment.
• Experience leading onboarding and accelerated mobilization of new assets post‑acquisition is desirable.
• Demonstrated leadership in transitioning programs from clinical development to commercial manufacturing is desirable, including process validation and regulatory approval, in a cross‑functional matrixed organization.
• Demonstrated ability to lead statistical design of experiment strategy, execution, and interpretation, and to define CMC risk assessments and control strategies.
• Strong working knowledge of cGMP & ICH guidelines, global regulatory requirements & regulatory document authoring, with the ability to direct drug product CMC content and strategy
• Experience representing drug product CMC in regulatory agency interactions desirable

Skills:

• Strategic and operational leader with demonstrated scientific depth, business acumen, and accountability for program‑level technical decisions
• Demonstrated leadership skills with the ability to influence cross‑functional decisions, empower teams, and provide technical direction
• Excellent problem‑solving and risk management skills to lead resolution of complex, high‑impact technical issues
• Excellent written and verbal communication and interpersonal skills with the ability to lead cross‑functional collaboration, direct external partners, and present recommendations and decisions to senior stakeholders

Attributes:

• Accountable and detail‑oriented, setting and maintaining high standards of quality and compliance
• Demonstrated rigor in critical review and approval of documentation to ensure regulatory and quality robustness
• Proactive strategic thinker who owns complex technical challenges and empowers teams to deliver solutions
• Demonstrated ability to identify inefficiencies and lead sustained process improvements
• Ability to coach, mentor, and develop technical talent and emerging leaders
• Minimum requirement of 3 days a week in office

Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package. Full‑time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.

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 $204,300 - $249,700 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.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.