Exec. Director, Global Medical HAE Strategy Lead

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-in class 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 uson LinkedIn and Instagram.

JOB SUMMARY:

The Executive Director, Global Medical Affairs Lead, HAE will be responsible for global medical strategy and execution of the HAE priorities. In addition to building and maintaining external relationships among medical experts globally, the role interfaces substantially inside BioCryst with the country medical organizations as well as with cross-functional teams and the R&D organization. The Global Medical Affairs Lead, HAE will be a key member of the BioCryst Global Medical Affairs leadership team and will work collaboratively with other key disciplines across the company, such as Clinical Development, Commercial, HEOR, Market Access, Communications, Regulatory Affairs, Safety, Finance, Legal and Research. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Drives development of an integrated global medical strategy for the program(s) of responsibility in collaboration with regional / local medical affairs leads and medical affairs functions (publications, communications), while ensuring alignment with the program development and lifecycle strategy
• Provide strategic medical/scientific expertise for the assigned program and relevant therapeutic area(s)
• Represent global medical affairs on cross-functional teams, including sharing of clinical perspectives and evolving industry insights to inform strategic planning and serving as the single point of contact for global commercial and development counterparts
• Collaborate with HEOR, analytics and Real World Evidence leads to drive in development of an integrated data generation plan for medical affairs, including identification of data sources, gaps and coordination of plans to conduct non-regulatory-mandated clinical phase IIIb/IV, and RWE data generation
• Lead External Research Committee (ERC) providing scientific oversight, review and support for independent external research to address identified areas of interest
• Map out and collaborate with key opinion leaders (KOLs) to develop clinical therapeutic concepts, identify messages for scientific communications, and gain feedback on strategies to support the medical affairs plan
• Work with clinical development, market access and program teams to support inclusion of appropriate trial endpoint and outcome measures to address unmet needs and enable patient access as needed
• Work collaboratively with regional medical leads and country medical directors to plan and execute medical affairs strategic global advisory board sessions with healthcare providers to collect needed clinical insights to inform medical strategy and tactics
• Provide medical expertise in support of developing content (slides, websites, standard response letters) for medical communications and education to advance disease state and clinical understanding
• Review key manuscripts and publications, acting as primary sign off where needed
• Provide support at professional meetings and congresses, collecting insights and competitive intelligence, and developing tools that support medical functions at the meeting
• Demonstrate and apply a deep understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers
• Demonstrate, and lead by example, compliant behavior in all aspects of company work

EXPERIENCE & QUALIFICATIONS:

• Advanced degree (Pharm.D., Ph.D., M.D) required. 15+ 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 global medical affairs role, including integrated evidence generation planning
• 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
• 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.