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Role Description

Reporting to the Senior Vice President, Program and Portfolio Management, the Director, Program Management will be accountable for successfully driving all aspects of cross-functional asset development for one or more assets within our maturing early-stage clinical development pipeline. This newly created position comes as a result of multiple assets advancing in clinical development, as well as a number of new compounds soon expected to be entering our portfolio. Perspective Therapeutics has an immediate need for an exceptionally talented, highly-motivated, passionate program management professional with demonstrated expertise in early-stage oncology clinical drug development to join our team.

• In collaboration with the compound lead, will be accountable for leading one or more cross-functional program teams driving early to mid-stage (peri-IND -> phase II/III) clinical drug development programs of high complexity.
• Support asset strategy development, TPPs, protocol development/amendments, all facets of global phase I/II clinical trial conduct, regulatory agency interactions, coordination of CMC/manufacturing activities/dependencies, CRO/partner interactions, routine monitoring/reporting program status to executive management, ongoing assessment of opportunities, risks and resource needs (financial & personnel).
• Assist in defining program strategies, developing multiple development options/scenarios, creating/maintaining cross-functional development plans, timelines and budgets for each program and ensure progress versus plan.
• Schedule and efficiently lead recurring asset-specific, issue-driven, cross-functional program team meetings; maintain all supporting documentation (agendas, minutes, action items, timelines risk/issue logs, etc.).
• Partner with globally-deployed, internal and external team members/partners (including Preclinical/Discovery, Manufacturing/CMC, Quality, Clinical Development, Regulatory Affairs, Clinical Operations and Finance).
• Proactively identify and facilitate team review of program issues/risks and ensure mitigation plans are developed and implemented.
• Effectively facilitate science-based business decisions.
• Utilize scenario generation/analysis techniques to address diverse range of complex issues with significant business impacts.
• Coordinate development of resource and budget plans across functions to ensure adequate resources are applied to the program; in collaboration with Finance colleagues, routinely track budgets/spend for all assigned programs and ensure alignment with company’s strategic objectives.
• Provide input to the program prioritization process and participate in other key strategic business portfolio processes/initiatives.
• Lead and/or support continuous improvement and/or transformational initiatives that address unique strategic, operational and/or tactical issues.

Qualifications

• Advanced degree in life sciences or other relevant discipline.
• Minimum 7 years experience in biotech/pharma, preferably in the early development space, including 5 years in program/portfolio management or leadership of cross-functional matrix teams; strong preference given to candidates with experience/expertise in oncology, radiopharmaceuticals and/or successful functioning in early-stage startup/biotech environments.
• Understanding of disease area and drug development pathway with the ability to contribute to strategic discussions.
• Working knowledge of all related/contributing early development disciplines and functional areas.
• Strong quantitative and analytical skills, working knowledge of descriptive statistics and their application, generation/use of metrics and dashboards to guide team performance.
• Lead the development of critical path analyses and scenario planning.
• Familiarity with various program management tools (MS Project, Excel, SharePoint or similar, PowerPoint, etc.).

Requirements

• Knowledge of GCP practices, FDA regulations and ICH guidelines.
• Ability to thrive in driving program teams in resource-constrained, entrepreneurial, early stage start-up environments.
• Ability to resolve complex problems and manage difficult stakeholder situations.
• Flexibility to pivot to last minute changes as needed to ensure business continuity.
• Leadership skills including situational leadership, ability to lead a team of experts and influence without authority.
• Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
• Curiosity, learning agility and adaptability.
• Outstanding ability to communicate technical information to both technical and non-technical audiences.
• Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities.
• Ability to manage and prioritize multiple programs to ensure on-time delivery with meticulous quality.
• Ability to become well-versed with relevant medical and imaging concepts and terminology.
• Ability to facilitate meetings and discussions in person and virtually.
• Ability to travel up to 30%.

Work Environment

• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.