Company Overview
Pyros is a specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare diseases with unmet needs. With an initial focus on Infantile Spasms (IS) - a rare and sometimes life-threatening form of pediatric epilepsy - we recognize the significant emotional burden this condition imposes on families. Pyros is working to offer an enhanced treatment option for families affected by IS and other rare diseases.
Role Summary
The Executive D irector, Medical Affairs, reporting to the Chief Executive Officer, will lead the development and execution of medical affairs strategies and tactical execution. This individual will be responsible for leading the Medical Affairs Department including supervising medical marketing programs, the medical science liaison team, health pharmacoeconomic and outcomes research (HEOR), scientific communications, and medical operations. The incumbent requires an understanding of pharmaceutical business functions, products, strategic thinking, leadership, and a strong knowledge of the stakeholders and disease area treatment landscape. The position will involve high interaction with the leadership team as it relates to product launches and will hold a leadership role within the company on various strategic directions for rare diseases.
Responsibilities
• Deliver medical affairs leadership including developing strategic plans, evaluating specific unmet medical needs, and creating results-oriented plans to fill medical product data gaps in rare diseases.
• Serve as the final in-house medical data expert on Pyros' product data and disease states with expertise in presenting and teaching complex data to internal and external stakeholders.
• Design and execute the medical plan and strategies including life cycle management, and partnering closely with other functional groups including regulatory, commercial, and technical services.
• Oversee the MSL team for thought leader mapping, engagement, medical conference interactions, and additional activities performed by the MSL team that ensure effective and compliant scientific exchange to meet the needs of healthcare professionals and internal stakeholders.
• Develop strategic partnerships with advocacy/support groups, centers of excellence, and KOLs in areas of scientific interest.
• Provide collaborative input to the commercial team to facilitate creation of compliant, customer- focused strategies for disease state education.
• Provide medical reviews for commercial materials that support on-label use of Pyros' products to compliantly solve unmet medical needs of the patients, families, and care providers that we serve.
• Direct the strategic development and execution of post-approval phase 4 rare disease studies.
• Collaborate with healthcare professionals in the discussion of scientific and medical information including planning and execution of advisory boards and presentations at meetings.
• Develop and sustain close professional relationships with KOLs and evolving scientific leaders.
• Support medical communication activities including developing a publications strategy evaluating and authoring peer-reviewed abstracts and manuscripts, writing reviews, and collaborating with internal and external authors.
• Collaborate closely with regulatory affairs and integrate medical affairs perceptions into development plans.
• Work closely with the leadership team to develop milestones and deliverables within the budget. Skills & Requirements
• Ability to partner with healthcare professionals in the rare disease space and deliver valuable scientific guidance in clinical research, patient and caregiver burden, disease environment, and payer value.
• Ability to maintain scientific integrity while being commercially supportive, and to address scientific results and successfully respond to data inquiries from customers and consultants.
• Successfully manage a rare disease pharmaceutical product including work on or preparation for a successful product launch.
• Strong understanding of new product registration requirements and regulatory environment.
• Proven success of leading and developing high-functioning medical affairs teams.
• The flexibility, autonomy, and resourcefulness essential to lead a big-vision strategy and be hands- on.
• Strong strategic mindset, market knowledge, clinical development, medical, policy and technology skills.
• Comprehensive knowledge of the competitive environment in rare diseases.
• Strong MS Office and knowledge of database management.
• Ability to travel 35%. Qualifications
• PhD, PharmD, or MD .
• 10+ years of pharmaceutical or medical practice experience with 5+ years of increasing leadership responsibilities, including product launch planning and execution.
• Competitive salary and benefits package
• Medical, dental, vision (most tiers are fully compensated by Pyros)
• HSA and FSA
• Life and supplemental life insurance
• 401(k) with company match
• Generous PTO with rollover
• Generous holidays Company Overview
Pyros is a specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare diseases with unmet needs. With an initial focus on Infantile Spasms (IS) - a rare and sometimes life-threatening form of pediatric epilepsy - we recognize the significant emotional burden this condition imposes on families. Pyros is working to offer an enhanced treatment option for families affected by IS and other rare diseases.
Role Summary
The Executive D irector, Medical Affairs, reporting to the Chief Executive Officer, will lead the development and execution of medical affairs strategies and tactical execution. This individual will be responsible for leading the Medical Affairs Department including supervising medical marketing programs, the medical science liaison team, health pharmacoeconomic and outcomes research (HEOR), scientific communications, and medical operations. The incumbent requires an understanding of pharmaceutical business functions, products, strategic thinking, leadership, and a strong knowledge of the stakeholders and disease area treatment landscape. The position will involve high interaction with the leadership team as it relates to product launches and will hold a leadership role within the company on various strategic directions for rare diseases.
Responsibilities
• Deliver medical affairs leadership including developing strategic plans, evaluating specific unmet medical needs, and creating results-oriented plans to fill medical product data gaps in rare diseases.
• Serve as the final in-house medical data expert on Pyros' product data and disease states with expertise in presenting and teaching complex data to internal and external stakeholders.
• Design and execute the medical plan and strategies including life cycle management, and partnering closely with other functional groups including regulatory, commercial, and technical services.
• Oversee the MSL team for thought leader mapping, engagement, medical conference interactions, and additional activities performed by the MSL team that ensure effective and compliant scientific exchange to meet the needs of healthcare professionals and internal stakeholders.
• Develop strategic partnerships with advocacy/support groups, centers of excellence, and KOLs in areas of scientific interest.
• Provide collaborative input to the commercial team to facilitate creation of compliant, customer- focused strategies for disease state education.
• Provide medical reviews for commercial materials that support on-label use of Pyros' products to compliantly solve unmet medical needs of the patients, families, and care providers that we serve.
• Direct the strategic development and execution of post-approval phase 4 rare disease studies.
• Collaborate with healthcare professionals in the discussion of scientific and medical information including planning and execution of advisory boards and presentations at meetings.
• Develop and sustain close professional relationships with KOLs and evolving scientific leaders.
• Support medical communication activities including developing a publications strategy evaluating and authoring peer-reviewed abstracts and manuscripts, writing reviews, and collaborating with internal and external authors.
• Collaborate closely with regulatory affairs and integrate medical affairs perceptions into development plans.
• Work closely with the leadership team to develop milestones and deliverables within the budget. Skills & Requirements
• Ability to partner with healthcare professionals in the rare disease space and deliver valuable scientific guidance in clinical research, patient and caregiver burden, disease environment, and payer value.
• Ability to maintain scientific integrity while being commercially supportive, and to address scientific results and successfully respond to data inquiries from customers and consultants.
• Successfully manage a rare disease pharmaceutical product including work on or preparation for a successful product launch.
• Strong understanding of new product registration requirements and regulatory environment.
• Proven success of leading and developing high-functioning medical affairs teams click apply for full job details
Date Posted: 05 May 2024
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