Director, Program Management (Development)

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 us on LinkedIn and Instagram. 

JOB SUMMARY:

The Director, Program Management provides leadership, technical and operational support to enable cross-functional development program teams to effectively strategize, plan, execute and report on the full lifecycle of BioCryst’s product development through registration and commercial launch. The incumbent facilitates cross-functional teams comprised of both internal and external resources to assist with the development of project plans, to drive teams’ progress in meeting strategic and operational objectives, and to ensure on-going alignment across functions. He/she ensures creation and maintenance of all associated project plans and applies program management expertise and leadership to clinical, regulatory, manufacturing, supply chain, commercial and finance, as well as other internal operations as necessary. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Working in partnership with Product Team Leader and cross-functional development program teams to ensure on-going alignment to program team goals and objectives and overall execution of program objectives and deliverables; helps team manage issue resolutions and facilitate team’s evaluation and development of recommended strategic plans.
• Creates and maintains high level program timelines, tracking and raising issues and providing timely updates to the project team on off-track activities; ensures efficient and timely communication between/across functions and senior management.
• Actively manages integrated and accurate strategic development project plans and associated timelines; maintains correct interdependencies of activities within the timelines; identifies critical path tasks and deliverables; identifies risks/challenges and assists with the development and implementation of risk mitigation plans.
• Assists with identifying, implementing and communicating across projects the best practices related to the development, initiation, planning, execution, control and closing of pre-clinical, clinical studies, and/or studies to support post-approval requirements.
• Leads and facilitates project team meetings comprised of internal and external representatives including but not limited to: clinical operations, statistics, medical writing, safety, clinical supplies, regulatory affairs, quality, pharmaceutical development and manufacturing, finance, legal, etc. Earlier stage projects may also involve participation from discovery (research, pre-clinical pharmacology, toxicology, etc.) while later stage projects involve participation from medical affairs, marketing.
• Serves as primary point of contact for project teams on status of all study related issues, both on-going and potential, as appropriate.
• Acts as primary point of contact to project teams on status of all functional activities; liaises with team members across line functions to gather/communicate project-related information; prepares, monitors, and maintains the project schedule and program deliverables.
• Performs other tasks and assignments as needed and specified by management.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree required; science-related field preferred. Advanced degree in a similar science-related field or in Management preferred
• Minimum of 10 years’ experience (or an equivalent combination of education and experience) with progressive responsibility in clinical development or pharmaceutical research and development (R&D)
• Minimum 5 years of experience in a project management role in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment. Experience in rare disease drug development preferred.
• In-depth understanding of the drug developmental process including hands-on experience managing cross-functional development teams across all stages of development (pre-IND, clinical development, global regulatory filings, approvals, and post-marketing).
• Experience with regulatory preparations and submissions for FDA, EMA, and other national regulatory agencies, as well as the ongoing processes and procedures tied to the New Drug Application and Marketing Authorization Application reviews.
• Working knowledge of clinical trial design, conduct, data acquisition and reporting.
• Ability to provide project management support for development programs delivered on time and within budget.
• Ability to influence without direct authority. Demonstrated skills in negotiation and facilitation.
• Excellent verbal and written communication and skills including presentation skills; Proficiency with Microsoft Office (including MS Project).
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Knowledge of change management.

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.