Exec. Director, Global Medical Affairs Strategy

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable 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 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 LinkedInand Instagram.

JOB SUMMARY:

The Executive Director, Global Medical Affairs, will lead the Global Medical Affairs Team activities associated with late-stage development, launch, and post-market lifecycle management of the designated BCRX program. The ED, Global Medical Affairs is accountable for alignment of Global Medical Affairs activities with Global Program Management plans and objectives. The ED, Global Medical Affairs is responsible for interacting with various research institutions, internal departments and investigators to orchestrate Global Medical Affairs objectives for an assigned program, while ensuring the medical and scientific merit of company activities. The position 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, Communications, Regulatory Affairs, Safety, Finance, Legal and Research.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Represent global medical affairs on cross-functional program team, including sharing of clinical perspectives and evolving industry insights to inform strategic planning
• Works closely with regional medical affairs leads and local country medical directors to collaboratively develop an integrated global medical strategy for the program(s) of responsibility, while ensuring alignment with the program development and lifecycle strategy.
• Provide strategic medical/scientific expertise for the assigned program and relevant therapeutic area(s).
• Closely collaborate with regions/countries to provide guidance and strategy; integrate the needs of the country KOLs/HCPs to the global strategy; and provide medical expertise/support to the affiliates as needed.
• Work collaboratively with regional medical leads and country medical directors to plan and execute 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.
• 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.
• Work closely with regional medical affairs teams to access and regularly meet with global thought leader network to support the successful execution of Medical Affairs tactics
• Collaborate with HEOR, analytics and Real World Evidence leads in development of an integrated data generation plan, including identification of data sources, gaps and coordination of plans to conduct non-regulatory-mandated clinical phase IIIb/IV, and RWE data generation.
• 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.
• Work closely with respective program leads to provide clinically relevant guidance in support of mid-late phase study design.
• Provide scientific/clinical expertise in support of disease and product training in collaboration with key internal stakeholders.
• 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 AND QUALIFICATIONS

• MD/DO/PharmD/PhD with experience in developing and orchestrating aligned execution of global Medical strategy for a product launch or marketed product.
• 10+ years industry and/or relevant clinical/scientific experience in rare disease and/or relevant specialty indications required.
• Must possess excellent communication skills, relationship building capabilities, and proven ability to influence decision-making without authority.
• Must be willing and able to travel internationally, regularly attending international conferences and meeting with KOLs as necessary to establish trust and credibility of Biocryst
• A solid understanding of the industry's complex regulatory and compliance requirements with an absolute commitment to competing on the highest ethical level.
• Demonstrated strong ability to build and maintain key external relationships across key stakeholders.
• Flexible, entrepreneurial by nature, a collaborative team player who works well with patients, physicians, providers, payers, regulators, scientists and peers.

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, Veterans 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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