Madrigal Pharmaceuticals

Compensation

Full Description

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. Executive Director of Pharmaceutical Science Position Opportunity: 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. The role requires a highly collaborative individual that establishes excellent relationships/partnerships with Quality, Research, Regulatory Affairs, Drug Safety, Clinical, Supply Chain, external partners, etc. The role requires the strategic oversight of all Pharmaceutical Sciences activities at Madrigal, with a primary emphasis on Drug Product Formulations that insure that all drug safety studies and clinical trials are supported with appropriate quality IMP in a timely manner. This role will establish and oversee all externalized laboratory activities, including API form evaluation and selection, formulations to support drug discovery and pre-clinical activities and formulation design and development for clinical studies and ultimately commercial sale. The Executive Director of Pharmaceutical Science is accountable for the invention, development and validation of high quality API final forms, formulations and processes that are developed with a risk mindset consistent with regulatory and ICH guidance. The Executive Director of Pharmaceutical Science is expected to lead at least one cross functional CMC team responsible for the development of a Clinical Development Asset. The ideal candidate will be highly collaborative and build a high performing Pharmaceutical Science team that supports the development of an industry leading NASH/MASH focused pipeline. This position reports into the Vice President of CMC. Key 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 a set of CROs and CMOs that can both define products & processes for CMC teams and deliver formulations with systems and processes in compliance with all relevant regulatory standards Through CROs and CDMOs, execute plans for the validation and registration of formulations as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations Insure Intellectual Property Coverage is obtained to both enhance pipeline value and to insure Freedom to Operate Provide direction and oversight of the authoring and reviewing of Pharmaceutical Science documents for INDs, NDAs and other regulatory section 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 a API/CMC subject matter expert during US and ROW regulatory inspections and audits Qualifications and Skills Required: Education: • PhD degree in Pharmaceutical or Material Sciences, Organic or Inorganic or Analytical or Polymer Chemistry or a Master’s Degree and commensurate Pharmaceutical Science development and leadership experience 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 a 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 Skills: Strategic and operational leader with a balance of scientific depth and business acumen Strong Leadership skills with an ability to both influence and empower Strong technical expertise in Pharmaceutical Science, pharmaceutical 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, with external partners, and present to executive stakeholders Attributes: 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 Meticulous in review of documentation to ensure regulatory and quality robustness Ability to mentor others in quality and best practices Initiative in shaping compliance culture across the organization 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. The base salary range for this position is $270,000 - $332,000 per year. 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 HR@madrigalpharma.com. 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 HR@madrigalpharma.com. Join our growing team focused on transforming the treatment of people with liver diseases. 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.