Exec. Director, Global Medical Pipeline

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 Exec. Director, Global Medical Pipeline Lead will lead the global Medical Affairs activities associated with early and late-stage development, launch, and post-market lifecycle management of any designated BCRX program. They will be a strategic partner providing expert medical leadership to guide development and ultimately launch planning of current pipeline assets. This position will be true scientific expert and an extension of BioCryst Medical Affairs both internally and externally within the external community. They will help to collaboratively identify opportunities to further external scientific collaboration with clinical and scientific experts. This includes accountability for interacting with various research institutions, internal departments and investigators to orchestrate the Global Medical Affairs objectives, including evidence generation objectives for an assigned program, while ensuring the medical and scientific merit of company activities. The Global Medical Strategy Lead 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:

• Provide strategic medical/scientific expertise for the assigned program and relevant therapeutic area(s) with a focus on pipeline therapeutic areas
• Represent global medical affairs on cross-functional program team, including sharing of clinical perspectives and evolving industry insights to inform strategic planning and serving as the single point of contact for commercial and development counterparts
• Map out and collaborate with key opinion leaders (KOLs) 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
• 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
• 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
• 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.
• 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 during launch planning
• 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
• 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 pipeline assets.
• 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.