Department: Drug Development
Job Title: Program Executive
Description:
The individual in this highly visible strategic position will be responsible for providing leadership to a cross-functional program team engaged in the clinical development of product candidate from the pre-clinical stage through commercialization. This position will report to the Vice President, Development Operations and Planning.
Duties and Responsibilities
With his/her Team the Program Executive (PE) develops a strategy for the successful development of the product across multiple oncology indications. The PE interacts with key individuals across the entire organization, including Research, Development, Manufacturing, Quality, Clinical, Regulatory, Business Development and Commercial groups. The PE plays a central role in the management of external collaborations and/or partnerships as they relate to the assigned program. The PE interacts with senior management in establishing both short and long term plans and coordinates activities leading to regulatory filings. The PE has the overall vision for the program and works towards ensuring that the corporate objectives are met.
The PE develops program timelines, identifies milestones and critical path items and utilizes reporting tools to ensure that program goals are met as projected. The PE works with his/her team members to troubleshoot and solve problems under aggressive timelines while maintaining a high standard of excellence. The PE provides support to the Finance department during the annual budget cycle and monitors the approved program budget.
Scientifically, the PE will assist in the critical draft and review of technical reports, clinical study protocols and reports, and regulatory submissions. The PE must have a strong knowledge and understanding of regulatory requirements for product approval as well as compliance both in the US & Europe.
Job Requirements:
The ideal candidate for this position is an independent self-starter, energetic, team-orientated and able to partner well with all functional management. He or she will be detailed-oriented, pro-active, able to think across disciplines and organizations and to inject consistency in performance and results.
- A Ph.D., in biological sciences or an M.D. with previous experience managing a clinical development program in the biopharmaceutical industry is required
- Must have excellent communication (oral and written) and superb interpersonal skills
- Possess strong organizational, analytical, time-management skills
- Effective at facilitating, negotiating, and influencing across various levels and lines both within and outside an organization without direct authority
- Have a keen awareness of the industry and the drug development and commercialization pathways
- Prior experience in the development of oncology products, biomarkers, cancer diagnostics or cancer biology is a plus
