Role Summary
The Director of Development Operations, reporting to Chief Medical Officer, will be a member of the Development Leadership Team, accountable for facilitating effective communication and operational excellence within the development organization. This individual provides scientific and operational support to the CMO, including coordination of scientific engagement, cross-functional alignment, vendor contracting, resource planning and oversight of the development team. The ideal candidate is a proactive, highly organized, and outcome-oriented leader who thrives in a fast-paced, matrixed environment, with exceptional interpersonal skills to drive efficiency and effectiveness of development operations.
Responsibilities
- Provide scientific and operational support to the CMO across a broad range of development activities, including ad hoc scientific support (e.g., content management, SharePoint organization)
- Implement and coordinate key meetings (e.g., development leadership team, development review, protocol and data review), including scheduling, agenda development, content, and logistics
- Create internal and external presentations to meet departmental business needs, responsible for development of high-quality slide decks for cross-functional meetings (e.g., QBR, ET and board)
- Track and ensure timely follow-up on action items and decisions made during governance meetings
- Drive development effort in annual goal setting and resource planning, accountable for coordinating development budget planning, tracking and management of actual spend to ensure financial compliance
- Provide operational support for scientific engagement activities (e.g., KOL visits, advisory boards), including scheduling, agenda development, content, logistics, and archiving
- Liaise with finance, legal, and HR to ensure timely resolution of issues impacting development activities (e.g., CDA, MSA, distribution list) to facilitate onboarding of expert advisors, new hires and vendors
- Serve as a strategic thought partner to the development leadership team concerning issues, current and future initiatives, strategies, project management, and budgets
- Serve as a liaison between development and other key stakeholder functions to ensure consistent and effective communication
- Identify opportunities to streamline and enhance development operations processes and lead efforts to implement process improvements to increase operational efficiency
- Maintain and continuously improve documentation, templates, and tools used for governance and planning processes
Qualifications
- BA/MA in science required; advanced science training preferred
- Based in greater Boston requiring minimum 4-day per week presence in the Cambridge office
- Advanced proficiency in Microsoft Office Suite, especially PowerPoint and Word; familiarity with collaboration tools (e.g., Smartsheet, SharePoint)
- 5+ years of experience in biopharmaceutical, preferentially within development, with 3+ years of deep expertise in strategy and operations
- Exceptional communication skills, both verbal and written
- Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills
- Understanding of the drug development process from pre-IND through BLA
- Ability to travel as needed
Education
- BA/MA in science required; advanced science training preferred