Advanced degree in life sciences or other relevant discipline
Minimum 7 years experience in biotech/pharma including 5 years in program/portfolio management or leadership of cross-functional matrix teams, preferably in early development and oncology/radiopharmaceuticals
Strong quantitative and analytical skills with experience using metrics, dashboards, and critical path analyses
Knowledge of GCP, FDA regulations and ICH guidelines; ability to drive programs in resource-constrained, entrepreneurial, early-stage start-up environments
Requirements:
Lead one or more cross-functional program teams driving early to mid-stage (peri-IND - phase II/III) clinical drug development programs of high complexity
Develop and maintain cross-functional development plans, timelines and budgets; monitor progress and report status to executive management
Coordinate regulatory interactions, CMC/manufacturing dependencies, CRO/partner management, and risk mitigation; schedule recurring program team meetings with documentation
Proactively identify and facilitate review of program issues/risks and drive science-based business decisions using scenario analysis for complex issues
Job description
Objective
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.
Essential Functions
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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
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.)
Knowledge / Skill / Ability
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%.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
