Senior Director, ADME

Posted 13 Days Ago
Be an Early Applicant
Conshohocken, PA, USA
In-Office
256K-313K Annually
Senior level
Healthtech • Pharmaceutical • Manufacturing
The Role
Lead ADME strategy and execution for nonclinical and clinical programs. Design, oversee, and interpret in vitro and in vivo ADME studies, manage CROs, perform DDI risk assessment and PBPK modeling, integrate PK data to inform development, and author ADME regulatory sections supporting submissions and interactions.
Summary Generated by Built In

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

 

Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

 

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

The Senior Director, ADME will provide technical leadership and execution for ADME activities supporting nonclinical and clinical development programs. This role is primarily responsible for nonclinical ADME strategy and oversight, while supporting Clinical Pharmacology and early clinical development as a subject matter expert.

This individual will bring deep expertise in drug metabolism, with working knowledge across broader ADME disciplines, and will oversee all ADME studies conducted through CRO partners. The role requires strong hands-on scientific judgment to design, interpret, and integrate ADME data to support program decisions and regulatory submissions.

Key Responsibilities

  • Serve as the ADME subject matter expert, with deep expertise in metabolism
  • Define and execute ADME strategies in collaboration with functional area leads
  • Design, oversee, and interpret nonclinical ADME studies (in vitro and in vivo)
  • Manage CROs, including vendor selection, study design, protocol development, and report review
  • Ensure ADME data are scientifically sound and aligned with regulatory expectations
  • Support clinical development through ADME input, including DDI risk assessment, PBPK modeling, and human ADME (mass balance) study design and interpretation
  • Integrate nonclinical and emerging clinical PK data to inform ADME strategy and study design
  • Author and review ADME sections of regulatory submissions (IND/CTA, NDA) and support regulatory interactions

Qualifications

Education & Experience

  • Ph.D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related discipline (or equivalent experience)
  • 15+ years of ADME experience in pharmaceutical or biotechnology drug development
  • Experience supporting both nonclinical and clinical programs

Technical Expertise

  • Deep expertise in drug metabolism (required)
  • Working knowledge of transporters and broader ADME sciences
  • Strong experience designing and interpreting ADME studies
  • Experience with PBPK modeling and human ADME (mass balance) studies preferred

Core Competencies

  • Strong scientific judgment and attention to detail
  • Hands-on, execution-focused approach
  • Effective communicator within technical and cross-functional teams
  • Ability to operate in a fast-paced, dynamic environment

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 $256,000 - $313,000 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. 

 

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

 

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. 

 

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. 

 

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.  

 

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [email protected]. 

 

Skills Required

  • Ph.D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related discipline (or equivalent experience)
  • 15+ years of ADME experience in pharmaceutical or biotechnology drug development
  • Experience supporting both nonclinical and clinical programs
  • Deep expertise in drug metabolism
  • Working knowledge of transporters and broader ADME sciences
  • Strong experience designing and interpreting ADME studies (in vitro and in vivo)
  • Experience with PBPK modeling and human ADME (mass balance) studies
  • CRO management experience including vendor selection, study design, protocol development, and report review
  • Experience authoring and reviewing ADME sections of regulatory submissions (IND/CTA, NDA) and supporting regulatory interactions
  • Strong scientific judgment, hands-on execution focus, and effective cross-functional communication
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The Company
HQ: West Conshohocken, PA
430 Employees
Year Founded: 2016

What We Do

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist that is designed to target key underlying causes of NASH in the liver. Resmetirom is currently being evaluated in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits in patients with NASH. For more information, visit www.madrigalpharma.com

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