300 Technology Square
Job Category: Clinical: R&D Program Management
Job Number: 2057
Client is seeking a motivated Program Manager to join as a key member of our R&D teams. This person will be responsible for managing the planning and execution of oncology drug discovery programs from First in Human through late phase & pivotal clinical development. This involves organizing and managing a joint global multi-disciplinary team with pharmaceutical partners to deliver high quality data in accordance with budget and timelines. Critical to success is an understanding of the drug development process and a strong ability to drive the collaboration of highly-technical development teams to achieve program goals.
- Lead the project planning efforts to IND submission and execution of early clinical studies, organize translational and clinical subteams in defining and implementing the asset strategy. Actively manage all aspects and progress of multiple programs towards timely milestone achievement.
- Direct and ensure communication alignment on technical, organizational, and budgetary affairs with management and our pharmaceutical alliance partner.
- Manage team operations (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items) Maintain program-related documentation and ensure appropriate archiving and access to shared information and critical program documents Facilitate alignment and cross-functional communication between discovery, late phase research, CMC, Clinical and regulatory to enable the team to meet the program goals Work with the team to develop options, scenarios, recommendations, risk mitigation strategies and integrated operational plans to achieve program objectives Facilitate internal decision-making processes and prepare regular updates for senior management Providing project management support: developing and managing timelines for key projects, developing and implementing processes, ensuring strong lines of communication to the project team and leadership, and ensuring best practices are followed Assisting Project Leaders and Core Team members with complex program deliverables and issue resolution.
- Supporting optimization of development plans by evaluating assumptions and incorporation of new inputs as the projects progress through development and integration of activities across research including support with resource/budget planning Serve as company representative for project management for partnered research and developmental programs with academic, emerging Biotech as well as our strategic alliance partner
- Relevant Scientific Degree (BS, MS or PhD)
- 5-10 years prior Biotech/Pharmaceutical experience as a program manager preferred with a track record of successfully managing clinical drug development programs
- Some late phase (Phase 2-3) experience preferred
- Excellent interpersonal, organization, verbal and written communication skills
- Problem-solving skills
- Attention to detail
- Ability to organize and prioritize tasks in a timely and accurate manner
- Ability to meet tight deadlines
- Ability to work collaboratively in a dynamic environment
- Computer programs systems: Highly Proficient with the following MS Office (Word, Excel, Powerpoint), familiarity with Project Management software, SharePoint and Webex (or other similar systems)