Madrigalpharma
Sr. Director Medical Affairs Strategy
Madrigalpharma, Conshohocken, Pennsylvania, United States,
About Madrigal:
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
The Sr. Director Medical Affairs Strategy is responsible for developing and executing strategic medical plans and providing scientific and medical expertise to support those plans including, but not limited to, lifecycle management, insights generation, advisory board strategy, scientific platform and lexicon and medical education. Reporting to the Vice President, Global Medical Affairs Strategy, the Sr. Director, Medical Affairs Strategy serves as the subject matter expert to create the indication-specific or product-specific Medical strategic framework and prioritized Medical Affairs tactics to ensure the success of resmetirom throughout the product lifecycle. This individual will bring together strong technical knowledge of the therapeutic area, strong command of the relevant clinical practice guidelines and related scientific data and a deep understanding of resmetirom. In partnership with the VP, Medical Strategy, this role develops medical strategy in close collaboration with R&D, Medical Directors within Scientific Communications, Field Medical and Medical Excellence to support the department and organizational objectives.
Position Responsibilities:
Develop and Execute Medical Affairs Strategy:
Strategically develop and execute Medical Affairs plans, ensuring alignment with the company’s overall business goals including the brand team. Create tactical plans for the company’s therapeutic area, adhering to regulatory requirements and Standard Operating Procedures (SOPs). Identify unmet medical needs and strategic insights and complete situational analysis to guide the company's medical and scientific priorities. Develop and execute an Advanced Practice Provider (APP) strategy in alignment with the corporate goals.
Insight Generation:
Synthesize summarized insights and implications from all relevant sources (e.g., ad boards, field medical, MI, congresses, etc.) and provide to Medical Affairs and cross-functional stakeholders, to inform medical strategy as appropriate. In addition, the Sr. Director will develop actionable plans to be utilized in advisory boards, medical education planning and life-cycle management. Advisory Board Strategy:
Develop and execute advisory board strategy based on strategic imperatives and insights collected. Medical Education:
Develop the medical education strategy and ensure implementation in line with the growth and maturation of the MASH field. Identify and implement optimal educational strategies to achieve goals including novel learning modalities and learning outcomes measures.
Medical Product Team:
Actively participate in the cross-functional team in the development and management of resmetirom, ensuring compliance, strategic alignment, and timely delivery with the medical strategy. Define key strategies and initiatives to support global asset and company goals.
Manage Product Lifecycle:
Develop the entire lifecycle plan of resmetirom, from development through commercialization and post-market activities, ensuring alignment with strategic goals and regulatory requirements. Identify and implement opportunities for product enhancements, optimization, and updates based on market feedback, performance metrics, and evolving industry standards. Develop and implement strategies in collaboration with VP Diagnostics to ensure the integration of novel biomarkers and diagnostic tools in clinical trials and practice.
Develop and Maintain Scientific Lexicon:
Create and manage a comprehensive scientific lexicon that standardizes terminology and enhances clarity across research and clinical documentation. Lead the design and implementation of scientific platforms that integrate data and insights, facilitating efficient knowledge sharing and decision-making. Oversee the accuracy and consistency of scientific content within platforms, ensuring alignment with current research/strategic focus and regulatory standards.
Engage with Key External Stakeholders:
Act as an external interface with stakeholders including clinicians, insurers, government leaders, professional societies, and medical-scientific institutions. Ensure engagement with the medical community through scientific advisory boards, stakeholder engagements, webinars, and presentations. Serve as a spokesperson for the company in scientific forums and with healthcare professionals.
Collaborate across Functions:
Partner with R&D, Market Access, regulators, Commercial and Brand Team to ensure alignment with the company’s overall business goals. Medical Expertise and Leadership:
Provide strategic leadership and medical expertise to guide the development and implementation of clinical programs, ensuring alignment with regulatory standards and organizational goals. Qualifications and Skills Required: Advanced scientific/healthcare degree required (e.g., MD, PharmD, PhD, MS, etc.) Minimum 12 years in the pharmaceutical industry in a position that developed and executed against a medical strategy Strong track record of written and oral communication skills to develop and present medical strategies to varied audiences and articulate messages succinctly Understands detailed technical information and conveys complex ideas to a variety of audience types and cultures Strong organizational skills to track numerous tasks for multiple simultaneous projects in a deadline-oriented environment Role is based in Conshohocken, PA. Incumbent must be able to regularly commute into the office per our hybrid work policy. Ability to travel up to 10% of the time to medical congresses, both domestic and international Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance. 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.
#J-18808-Ljbffr
Strategically develop and execute Medical Affairs plans, ensuring alignment with the company’s overall business goals including the brand team. Create tactical plans for the company’s therapeutic area, adhering to regulatory requirements and Standard Operating Procedures (SOPs). Identify unmet medical needs and strategic insights and complete situational analysis to guide the company's medical and scientific priorities. Develop and execute an Advanced Practice Provider (APP) strategy in alignment with the corporate goals.
Insight Generation:
Synthesize summarized insights and implications from all relevant sources (e.g., ad boards, field medical, MI, congresses, etc.) and provide to Medical Affairs and cross-functional stakeholders, to inform medical strategy as appropriate. In addition, the Sr. Director will develop actionable plans to be utilized in advisory boards, medical education planning and life-cycle management. Advisory Board Strategy:
Develop and execute advisory board strategy based on strategic imperatives and insights collected. Medical Education:
Develop the medical education strategy and ensure implementation in line with the growth and maturation of the MASH field. Identify and implement optimal educational strategies to achieve goals including novel learning modalities and learning outcomes measures.
Medical Product Team:
Actively participate in the cross-functional team in the development and management of resmetirom, ensuring compliance, strategic alignment, and timely delivery with the medical strategy. Define key strategies and initiatives to support global asset and company goals.
Manage Product Lifecycle:
Develop the entire lifecycle plan of resmetirom, from development through commercialization and post-market activities, ensuring alignment with strategic goals and regulatory requirements. Identify and implement opportunities for product enhancements, optimization, and updates based on market feedback, performance metrics, and evolving industry standards. Develop and implement strategies in collaboration with VP Diagnostics to ensure the integration of novel biomarkers and diagnostic tools in clinical trials and practice.
Develop and Maintain Scientific Lexicon:
Create and manage a comprehensive scientific lexicon that standardizes terminology and enhances clarity across research and clinical documentation. Lead the design and implementation of scientific platforms that integrate data and insights, facilitating efficient knowledge sharing and decision-making. Oversee the accuracy and consistency of scientific content within platforms, ensuring alignment with current research/strategic focus and regulatory standards.
Engage with Key External Stakeholders:
Act as an external interface with stakeholders including clinicians, insurers, government leaders, professional societies, and medical-scientific institutions. Ensure engagement with the medical community through scientific advisory boards, stakeholder engagements, webinars, and presentations. Serve as a spokesperson for the company in scientific forums and with healthcare professionals.
Collaborate across Functions:
Partner with R&D, Market Access, regulators, Commercial and Brand Team to ensure alignment with the company’s overall business goals. Medical Expertise and Leadership:
Provide strategic leadership and medical expertise to guide the development and implementation of clinical programs, ensuring alignment with regulatory standards and organizational goals. Qualifications and Skills Required: Advanced scientific/healthcare degree required (e.g., MD, PharmD, PhD, MS, etc.) Minimum 12 years in the pharmaceutical industry in a position that developed and executed against a medical strategy Strong track record of written and oral communication skills to develop and present medical strategies to varied audiences and articulate messages succinctly Understands detailed technical information and conveys complex ideas to a variety of audience types and cultures Strong organizational skills to track numerous tasks for multiple simultaneous projects in a deadline-oriented environment Role is based in Conshohocken, PA. Incumbent must be able to regularly commute into the office per our hybrid work policy. Ability to travel up to 10% of the time to medical congresses, both domestic and international Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance. 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.
#J-18808-Ljbffr