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. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, 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 Director, Publication Strategy and Execution, is a highly visible senior leader who will be responsible for leading the strategy and implementation of the Publications plan. This individual will be a critical member of the Medical Affairs Extended Leadership Team and will work closely with cross-functional leaders, especially in close collaboration with product and program leadership teams, clinical development, biostatistics, regulatory affairs, HEOR, medical affairs, and marketing.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Serve as the subject matter expert on publication-related matters, working closely with both internal and external disease area experts to ensure relevant data, analysis, interpretation, communication, and publication planning of data
Adhere to good publications practices and ensure compliance with BioCryst policies
Develop and revise internal guidance and policies as needed in support of publication activities
Deliver training to internal cross-functional teams and external partners, as appropriate
Lead development of medical and scientific publications including accountability for execution of deliverables across hereditary angioedema and pipeline portfolio:
Effectively coordinate, allocate resources for, and in cases, execute development of abstracts, posters, oral presentations, manuscripts, and/or presentations for scientific/medical meetings to support Publications Plans for all compound(s)
Coordinate resources for writing, editing, formatting and submitting articles to peer-reviewed scientific journals and scientific/medical conferences
Build and maintain excellent relationships with clinical experts, journal editors, and congress personnel
Manage annual budget, work, and allocation of resources, including ensuring contracts, SOWs, and invoices are submitted accurately and in a timely manner
Day-to-day vendor management to execute publications effectively and efficiently according to the Publications Policy and good publication practices (GPP).
Provide oversight of maintenance of documents in the publication planning platform software to ensure completeness, accuracy, and integrity, while keeping abreast of the latest GPP and ISMPP standards.
EXPERIENCE & QUALIFICATIONS:
Advanced scientific degree required (PharmD, PhD, MD/DO)
Minimum 10 years of Medical Affairs experience in the pharmaceutical industry and/or relevant clinical or scientific experience, including leading scientific publications
Experience developing and executing integrated publication strategies across pre-launch, launch, and post-launch phases, aligned with medical strategy, evidence-generation priorities, scientific platforms, congress milestones, and lifecycle management objectives
Pipeline portfolio and rare disease experience required, with the ability to adapt publication strategies across early- and late-stage assets, evolving evidence plans, and changing program priorities
Expert knowledge of good publication practices and guidance, including GPP and ICMJE, and other standards related to scientific data communication
Demonstrated understanding of clinical trial design and execution, statistical methods, and clinical trial data reporting requirements
Ability to define and track publication performance metrics, assess scientific communication impact, and apply insights to optimize publication planning and execution
Demonstrated leadership skills, including the ability to collaborate, influence, and execute within large matrixed, cross-functional teams
Experience managing and developing high-performing teams, including setting priorities, providing coaching and feedback, supporting professional growth, and fostering accountability in a matrixed environment
Strong project management skills with the ability to manage multiple priorities and deliver successful outcomes, including publication planning, medical and technical writing, editing, and review
Ability to think strategically, critically analyze complex data, and synthesize scientific information into clear communication strategies
Excellent written and verbal communication skills, with a proven track record of developing and delivering high-quality scientific content
Proficiency with Microsoft Office applications and document management systems (e.g., PubStrat, SharePoint, Veeva Vault, Smartsheet) required
Ability to travel domestically and internationally approximately 25% of the time
Preferred Qualifications and Experience:
Certification as a Medical Publication Professional (CMPP) preferred
Hereditary angioedema/immunology/rare disease experience preferred
Experience with digital and innovative publication approaches, including enhanced publications, plain language summaries, digital congress assets, and technology-enabled publication workflow tools, preferred 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
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.