VP, Global Medical Affairs
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The VP, Global Medical Affairs provides leadership and strategic direction to Medical Affairs supporting the strategy for thought leadership, pre and post marketing activities and medical affairs management for multiple commercial products across three business units including government medical counter measure products. Responsible for the medical contribution to the company’s labeling and promotional materials review and assigns appropriate delegates. He/She oversees and is responsible for the integration of pre-and post-marketing safety surveillance with Medical Affairs activities and for ensuring an integrated and proactive approach to risk management. He/she serves as an ambassador at external scientific and industry meetings.
The VP Global Medical Affairs is a member of the medical/ clinical/ regulatory (Technical Operations) senior leadership team and is responsible for corporate oversight in the execution of the development and implementation of Medical Affairs strategies, as well as manages the organizational planning and operations of the department. This position is located in Gaithersburg, MD.
Leadership and strategy
- Lead a team of multidisciplined medical affairs leaders to support products in multiple portfolios – Medical Counter Measures, medical devices and infectious diseases.
- Serve as a company expert and resource for addressing key clinical and regulatory strategies, including but not limited to, promotional, CMC, developmental and compliance aspects related to the execution of the core business of pharmaceutical development as it relates to commercialization and manufacturing of products.
- Collaborate with commercial leadership on product portfolio to ensure appropriate disease and product education.
- Provide key input to R&D teams and Clinical Development for life cycle management planning.
- Integrate MA and PV activities into a state-of-the-art approach to pre and post-marketing risk management.
- Provide effective leadership to the Medical Affairs Department establishing goals and formulating strategy in collaboration with the appropriate business units.
- Provide the necessary resources and expertise to meet department goals; insure department and corporate goals are met; establish a department budget and operate within that budget.
- Represent and promote the company to outside organizations, including regulatory agencies, professional organizations and business partners.
- Represent corporate oversight in steering committee meetings, strategic collaborations and clinical development review meetings across therapeutic areas.
- Provide expert consultation and partnership for commercial products in the following areas:
- Responsible for the oversight of promotional review in order to develop and implement strategies and procedures that are compliant.
- Ensure product labeling is developed in compliance with applicable regulatory requirements and maintained with a controlled process.
- Responsible the establishment and support of medical affairs strategies for all development and commercial products. These important activities are intended to enhance awareness of EBS activities in our mission to protect and enhance life. Such important activities include but are not limited to the following:
- Key Opinion Leader engagement and education
- Medical messaging and strategies by product
- Focused participation in Medical and Commercial Advisory Boards
- Active participation in speaker identification/ training as well as the development and training of new Sales personnel
- Support and/ or execution of primary and secondary product publications
- Active participation in and leadership of medical meeting/ congress planning including abstracts, posters, and oral presentations
- Full ownership and leadership of all aspects of product lifecycle support (e.g. Annual planning, investigator study support, Phase 4 studies as needed, etc.)
- Key partner to both regulatory affairs and clinical development
- Key member of the product development team to ensure that our products are advanced effectively and positioned for success.
Organization and Operations
- Lead a team of medical affairs leaders who will work across business units in a collaborative manner to provide insight
- Optimize processes within Medical Affairs to ensure adherence to applicable regulatory requirements and company policy and efficiency in the conduct and management of day-to-day operations.
- Lead and collaborate with the Clinical Development in a manner that promotes employee satisfaction, engagement and productivity.
- Efficiently communicate and exchange clinical and scientific information to both internal and external customers.
- Build and maintain excellent relationships with the scientific community; build and maintain KOL networks in the therapeutic areas of interest for the company.
- Contribute to the publication plans for the company’s products and serve as chair of the publication planning committee.
- Ensure that effective and compliant risk management plans are developed and implemented for the company’s investigational and marketed products.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- MD with 15 years of Medical Affairs experience with a track record of successful leadership of medical affairs, KOL management, medical science, pharmacovigilance and publication management.
- Experience working with commercial and clinical programs for multiple therapeutic areas with an emphasis on infectious disease and / or medical devices.
- Established network among Key Opinion Leaders in the infectious disease field in the U.S. and internationally is desired.
- Ability to critically interpret and use scientific and clinical data to formulate new conceptual frameworks and disease management approaches.
- In-depth knowledge of regulatory and legal environment of developing and marketing drugs in the US and globally.
- Understanding of the healthcare market both in the U.S. and globally.
- Ability to work effectively with strategic alliances/joint ventures.
- Leadership experience dealing effectively with cross-functional groups across Commercial, Clinical Development, Business Units, Regulatory Affairs, and Strategy.
- Track record of effective people management.
- Strong medical orientation; high scientific and ethical integrity.
- Proven record of excellent verbal and written communication skills.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
- The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
Job posted: 2020-06-03