Madrigalpharma
Executive Director, Pharmaceutical Science
Madrigalpharma, Phila, Pennsylvania, United States
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PA - Pennsylvania – Remotetime type:
Full timeposted on:
Posted Todayjob requisition id:
JR\_000485Madrigal 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 #J-18808-Ljbffr
PA - Pennsylvania – Remotetime type:
Full timeposted on:
Posted Todayjob requisition id:
JR\_000485Madrigal 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 #J-18808-Ljbffr