Reports to: COO
The Head of Program and Portfolio Management, under the direction of the Chief Operating Officer, is responsible for leading the coordination, planning and budgeting of all activities associated with advancing programs through exploratory research, development, regulatory submission, manufacturing and product launch. High expectations are placed on the Head of Program and Portfolio Management to lead the drug development process in a timely and financially responsible manner. This individual will be responsible for utilizing systems and processes to track budgets, resource utilization and timelines for each project.
Additionally, the Head of Program and Portfolio Management will be responsible for maintaining outstanding communications with all functional leaders and providing key information and updates to the Executive Management team and the BOD.
Specific responsibilities include:
- Lead the project team and functional leads in the development, documentation, implementation and monitoring of comprehensive, integrated product/project plans and timelines, including activity identification, task duration, task logic, critical path identification and personnel resourcing estimation.
- Develop program budgets and track against actuals.
- Optimize these plans for value creation, time required, resources and risk, while ensuring that the program strategy is aligned with business objectives.
- Monitor adherence of project activities to agreed time, resources, budget and scope.
- Drive sound and timely decision-making through the identification and evaluation of options.
- Ensure projects have adequate resources and appropriate technical expertise to meet their objectives.
- Facilitate information flow between project team members, functions, senior management and vendors. Present project updates, strategic issues, options and recommendations to the Executive Management team.
- Highlight issues and risks; drive decision making, lead contingency planning and conflict resolution.
- Provide guidance to management and team leaders regarding product development and commercialization processes.
- Participate in strategic discussions with Executive Management involving company priorities, business objectives and plans to meet these objectives.
- Represent the company externally, as needed.
- Maintain commercial, scientific, regulatory and manufacturing awareness to ensure that the project plans reflect the latest scientific/medical developments and regulatory/commercial environment.
- May author sections of regulatory, scientific and commercial documents.
- Advanced degree in science, engineering, medical or business discipline required. Additional/postgraduate degrees a plus.
- Minimum of 15 years of biopharmaceutical industry product development experience; in-depth knowledge and experience in all stages of development, from early proof of concept studies to global late-phase (phase 2/3) drug development, regulatory submissions, approval and commercialization processes.
- Experience working in a fast-paced, entrepreneurial, development-stage company is highly desirable.
- Outstanding knowledge of program management and business process improvement, preferably across multiple functional areas; excellent quantitative and qualitative analysis, budgeting, financial planning and tracking skills.
- Excellent leadership, communication and collaboration skills and track record; proven ability to manage development projects, leading cross functional teams, and interacting with Executive Management.
- Ability to provide Executive Management with candid and accurate information regarding project progress.
- Hands-on, “roll up your sleeves” approach toward achieving business results.
- Strategic thinker with excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive agreement among individuals from a variety of cultures, and disciplines.
- Ability to challenge the status quo and identify improvement opportunities where relevant, while maintaining clear focus on business objectives. Ability to drive, anticipate, influence and implement change.
- Ability and experience in working with external partners to achieve business results.
- Knowledge of FDA requirements, Good Clinical Practices, Good Manufacturing Practices and pharmaceutical product development highly desirable.
- Excellent listening and communication skills with an ability to efficiently and productively communicate both orally and in writing.
- Strong personal presence with ability to command respect through exercise of sound business judgment and clear decision-making.
- Position will require domestic and international travel (~25%).