Vp, Global Development & Product Team Leader

Company

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. 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 the Company’s website at www.biocryst.com.

Job Summary

The VP, Global Development & Product Team Leader at BioCryst Pharmaceuticals (BioCryst) is an executive level role with extensive experience in cross functional management, project management, team and personnel management, business operations, and strategic planning in a pharmaceutical setting working closely with senior leadership in setting, leading, and meeting company objectives. This position is responsible for providing high-level experienced leadership and direction to cross-functional product teams and partnering with key functions to formulate the strategic drug development program. The VP, Global Development & Product Team Leader works to develop, implement and oversee key initiatives focused on the coordination of the company’s overall product development programs including the integration of clinical, CMC, nonclinical and regulatory plans, into overall product development programs, to achieve the company’s objectives. The VP, Global Development & Product Team Leader functions as a key interface between cross functional teams and senior management.

Essential Duties & Responsibilities

• Prepares project timelines that contain all activities, resources, and costs to accomplish key milestone dates for integration into the project schedule.
• Leads the team in preparation and approval of drug and clinical development plans, budgets, and proposed go/no-go decision criteria for development programs ensuring the needs and requirements of all regions are met.
• Establishes and maintains effective communication and collaboration with functional areas, including basic research, manufacturing, regulatory, quality assurance, business development, and marketing to meet project objectives and support achievement of department and corporate goals.
• Maintains an understanding of project management techniques, regulatory policy, and medical practice as they impact pharmaceutical development.
• Monitoring day-to-day activities to ensure that time and cost commitments are met.
• Develops communication mechanisms to notify appropriate decision makers of project requirements that may be impacted by resource limitations, priority conflicts, etc. resulting in potential delays in commitments.
• Provides perspective on project prioritization, milestone gating and opportunities to improve project value.
• Creates and encourages a team environment to openly, effectively, expeditiously and consistently resolves issues between functions.
• Works proactively to ensure team unity and morale and serves as a mediator when appropriate to resolve issues involving team members.
• Provides guidance and expertise on team organization and dynamics.
• Partners with Finance to understand the overall project budget and assess impacts to the financial plans resulting from project activities and issues.
• Tracking team performance against corporate objectives, team objectives, milestones, timelines and metrics.
• Identifies performance issues that impact the ability to achieve its objectives.
• Supporting partner alliances by ensuring the product development team activities are aligned with company priorities and partner needs.
• Assures that teams consistently meet goals, objectives, and commitments on time.
• In accordance with corporate standards, implements project management processes, tools, and templates to facilitate the management of project activities including:
• Organizes and executes effective presentations of consistently high quality to senior management on the activities/status of projects, including monthly highlights, information/status updates and milestone presentations.
• Provides support for business scenario analysis and planning.
• Serving as a mentor to team members by educating others on the skills to lead teams effectively and on the pharmaceutical development process.
• Managing activities and processes for the development of key project deliverables and documents as identified by the project team.
• Leading the design of innovative and executable development plans that efficiently meet and align corporate, commercial, and regulatory goals.
• Ensuring alignment of team processes and activities.
• Works frequently with senior management to resolve resourcing and prioritization conflicts across functions to ensure efficient design and flawless execution of a strategic development plan that maximizes the value of the program.
• Providing leadership to cross functional teams comprised of diverse specialists by utilizing effective leadership and project management skills and techniques, to establish team objectives and innovative strategies.
• All other duties as assigned.
• Working directly with the team to identify any all cross functional dependencies and constraints and facilitate resolution activities to achieve the desired outcomes.
• Monitoring the day-to-day interactions with project core and ad hoc team members from various functions – Clinical Development, Regulatory Affairs, Research, Manufacturing Commercial, Finance etc.

Experience & Qualifications

• Undergraduate degree in a science or engineering discipline.
• Alliance and external partner relationship management experience.
• Experience working with research or development projects in collaboration with US government agencies, academic institutions or nonprofit organizations that advance the development of scientific research
• Ability to recommend high-level decisions and to communicate effectively on a senior management level and externally.
• Knowledge and experience with quality management methodologies.
• Knowledge and experience of virological mechanisms, methods and assays in the context of agents developed for therapeutic use
• Proven experience in leading a team to reach major development milestones, e.g. regulatory submissions (i.e. IND, NDA, BLA), product launches, business development deals.
• In-depth knowledge of the Pharmaceutical R&D process and regulatory environment.
• Demonstrated analytical and information technology skills (project management, document management, and finance management).
• Ability to apply good business judgment to critically assess and prioritize issues.
• Very strong analytical, organizational, interpersonal, and written skills.
• Demonstrated ability to lead projects in a cross functional team environment.
• Familiarity with government funding mechanisms that can be accessed to fund advanced drug development initiatives
• Excellent problem solving and decision-making skills.
• Skilled in budget, expense management, cost estimation and cost efficiencies.
• Proven ability to lead and facilitate cross-functional teams comprised of technical professionals (internal and external).
• Proficiency in managing multiple tasks and priorities.
• Experience in developing and optimizing Pharmaceutical R&D processes.
• Knowledge and experience of project management concepts, techniques and processes.
• Demonstrated proficiency in a key discipline in drug development e.g., science, medical, commercial, operations, engineering, chemistry.
• Graduate level training in business and/or science is preferred (MD, PhD, PharmD, MBA) with 10+ years of experience (or an equivalent combination of education and experience) with demonstrated leadership ability in a project management and/or supervisory position.
• Strong presentation skills.

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.

BioCryst requires all U.S. based employees to either (a) establish that they have been fully vaccinated against COVID-19; or (b) obtain an approved exemption as an accommodation. Proof of vaccination or an approved exemption form is required after a conditional job offer has been made to the applicant and prior to the start date. This requirement is a condition of employment at BioCryst, and it applies regardless of whether the position is located at a physical BioCryst location or is fully remote.