Overview: We are seeking an experienced R&D Project Manager to oversee and coordinate all aspects of preclinical drug development through IND filing. The project manager will be responsible for managing detailed project timelines for both internal scientific teams and external CROs, and ensuring projects are delivered on-time and within budget. The ideal candidate will be able to proactively identify and resolve potential risks to avoid project delays and will also be well-versed in regulatory requirements in order to facilitate a smooth IND filing process. This is a critical role within our organization, requiring strong project management skills, scientific expertise, and the ability to drive complex projects to successful outcomes.
- Key Responsibilities: Oversee and manage all activities related to the preclinical development of drug candidates to enable successful IND filings.
- Develop and maintain detailed project timelines, tracking progress against key milestones, and ensuring project teams adhere to critical deadlines.
- Coordinate and manage relationships with contract research organizations (CROs) and other external partners, including contract negotiations and ensuring that deliverables are provided on time.
- Collaborate closely with internal scientific teams and external partners to ensure seamless communication, alignment of goals, and proper execution of project plans.
- Proactively identify potential project risks and bottlenecks, escalating issues when necessary and working to resolve them before they lead to delays.
- Track and manage project budgets, ensuring that all activities are completed within the allocated budget, and providing regular financial updates to leadership.
- Ensure that preclinical development activities are aligned with regulatory requirements, facilitating a smooth transition to IND filing.
- Maintain comprehensive project documentation and prepare reports to provide clear communication of project status, risks, and outcomes to senior management and other stakeholders.
- Required Skills and Experience: B.S. in Biology, Chemistry, Pharmacology, or related fields required; M.S. or Ph.D. preferred.PMP Certification is a plus but not required.
- B.S. with 10+ years of experience or M.S./Ph.D. with 5+ years of project management experience in the pharmaceutical or biotech industries, with experience overseeing/coordinating preclinical development activities through IND filing.
- Proven ability to manage complex R&D projects, including experience with timeline management, risk identification, and issue escalation.
- Experience coordinating activities with CROs and external partners, including contract negotiations and performance management.
- Familiarity with the regulatory requirements and processes involved in IND filing, and experience ensuring compliance with these standards during preclinical development.
- Excellent written and verbal communication skills, with the ability to clearly articulate project progress, risks, and recommendations to cross-functional teams and leadership.
- Experience with project management software (e.g., Microsoft Project or similar)
