COMPANY:
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-inclass or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.
JOB SUMMARY:
The Executive Director, US Medical Affairs Strategy will serve as the subject matter expert to create the indication-specific Medical strategic framework and prioritized medical tactics to ensure success of the respective product from a Medical Affairs perspective throughout the product lifecycle. This individual will bring strong technical knowledge of the therapeutic area, strong command of the relevant clinical practice guidelines and related scientific data, as well as understanding of the overall therapeutic area priorities and value drivers into an integrated strategic medical plan and tactics. The Executive Director, US Medical Affairs Strategy will work with relevant stakeholders to drive integrated medical plans and executable tactics. This role collaborates cross-functionally across the organization (including e.g. Global Medical Affairs, Clinical Development, US Marketing, US Market Access, Global HEOR, Analytics and Insights, Corporate Communications, Regulatory Affairs, Safety, Legal, Compliance) to create, execute, measure and adapt the medical strategy to best fit the needs of the US clinical landscape. #LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Develops and drives execution of strategic medical plan within region along with key functional and cross-functional partners.
• Provide strategic medical/scientific expertise for the assigned program and relevant therapeutic area(s) with functional and cross-functional partners
• Key medical affairs member on cross-functional teams to communicate clinical perspectives and evolving industry insights to inform strategic planning to ensure effective co-creation of appropriate, aligned and integrated strategic imperatives and associated outcome measures. Examples include publications and ECR/IIS grants committee as relevant for US regional proposals, US competitive intel response teams, product/indication-specific Clinical Development/Operations clinical trial teams as relevant.
• Core team member on Global Evidence Team, serving as lead for US regional data generation plans and real-world evidence, input into global plans and developing aligned regional strategy as appropriate, driving execution of regional data generation activities in alignment and collaboration with US medical field team and field team leadership.
• Builds and develops effective and collaborative relationships with identified Key Opinion Leaders and Patient Organization in the Country / Region.
• Provide medical and scientific expertise for strategic content development (slides, websites, standard response letters, training materials) in collaboration with key internal stakeholders for medical communications, US medical and commercial field team training, market access, marketing, among others.
• Develop strategic approach and lead medical content development for scientific exchange, advisory boards, educational symposia/programs, training initiatives, engagement of key opinion leaders and congress plans to ensure alignment with scientific platform.
• Builds and develops effective and collaborative relationships with top Key Opinion Leaders and academic centers in the Country / Region in collaboration with relevant functional and cross-functional partners.
• Provide leadership in identifying innovative research that may align with R&D capabilities and interest.
• Collaborate with thought leaders to develop clinical therapeutic concepts, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support medical affairs plan for pre-launch and marketed products.
• Leads projects with a US scope by taking full responsibility including alignment on goals with internal colleagues, exhibiting a problem-solving approach, assessment and coordination of resources, management of timeline, budget and vendors, conduct debriefing and recommend process improvements (Cross Functional Projects, Medical Information, Medical Communication, Visiting Professor Program, etc.)
• Partner with Market Access, Value & Access and Medical Information teams to co-establish strategic support plan and content creation in support of Access initiatives, as well as serve as subject matter expert support for key top national payers/systems.
• Facilitate coordination with US medical field team as appropriate to support internal and external training and education (speaker training, field team training, regional payor presentations)
EXPERIENCE & QUALIFICATIONS:
• Advanced degree (Pharm.D., Ph.D., M.D) required.
• 10+ years of related work experience (clinical, managed care, or industry experience); prior rare disease experience preferred.•
• Proven track record of consistent success within a strategic medical affairs role, including consistent and exemplary demonstration of core competencies and behaviors.
• Demonstrated mastery of core technical and/or clinical competencies and consistent, acknowledged contributions to BCRX medical/scientific efforts.
• Demonstrates advanced technical acumen within therapeutic area and recognized via external relationships.
• Proven track record of success establishing, building and maintaining scientific engagement with influential academic and clinical experts.
• Ability to think strategically; apply knowledge and analytical skills in a highly regulated environment and align medical and commercial strategies.
• Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner to a range of audiences.
• Outstanding business acumen; knows the industry, BioCryst’s value proposition, key competitors, and other marketplace factors/dynamics.
• Proven track record of excellent communication and collaboration skills, including recognition by cross- functional partners; work well independently while exhibiting professional maturity, confidence, and competence.
• Adherence and compliance with all required regulatory guidelines.
• Ability to travel and must possess a valid driver’s license. Weekend travel may be required.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veteran status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
