Role Summary:
Fore Biotherapeutics is seeking an experienced and highly motivated project management professional to support the development of plixorafenib, an investigational, orally available, small molecule selective inhibitor of mutated BRAF. The Sr. Project Manager will be responsible for providing project management support for ongoing development programs as well as planning of launch and commercial activities, co-ordination of regulatory filing activities, management of documentation, tracking of agreements and contracts as well as relevant technical documents and support of meeting scheduling.
The Sr. Project Manager will develop and implement Clinical, CMC and Regulatory project plans and ensure alignment of deliverables with the clinical development plan.
Essential Duties and Responsibilities
:
- Collaboratively partner with cross functional team members from key functional areas including Research, Regulatory, Manufacturing, Quality, Clinical and Safety to develop and execute integrated product development plans.
- Maintain cross-functional project plans, in collaboration with each functional lead, and provide routine updates to leadership.
- Responsible for driving collaboration for the development of the overall program strategy, including documentation and communication of decisions, actions, and risks. Also includes detailed deliverables and timelines for CMC, Clinical development, Regulatory, and other supporting functions.
- Ensure timely communication of changes in program strategy, issues and risks to team members and other functional areas as appropriate, including monitoring key deliverables, decision points, project milestones, demand planning, and critical path activities to drive delivery of project objectives.
- Develop agendas for meetings and produce high quality meeting minutes and related outputs to monitor program status.
- Work collaboratively with the Team Leaders and functional leaders to track the critical operational aspects of the program(s).
- Facilitate the management of risk by scheduling meetings with the teams as appropriate. Responsible for identifying risks and supporting the development of risk mitigation plans.
- Interface with vendors as needed to understand manufacturing activities and status
- Synthesize numerous sources of data and key analysis translating into specific actions to support company strategy.
- Lead the development of standards for project and process management
Education and/or Work Experience Requirements:
- BS, BA or equivalent in life sciences or health-related field and at least 5 years of relevant industry experience. PMP certification is a plus.
- Familiarity with FDA Center for Drug Evaluation and Research (CDER) protocols and guidelines as well as overall understanding and knowledge of IND application filing process.
- Familiarity with mid to late-stage clinical program management across all functions
- Oncology experience preferred.
- Outstanding organizational skills. Detail oriented. Proven ability to excel in a matrix environment. Strong record of attention to detail without losing sight of the larger goals. Ability to multi-task and handle multiple projects simultaneously.
- Strong project management, business process management, and optimization skills.
- Effective record keeping and presentation skills (including the ability to develop clear and concise presentations) are required.
- Has an established broad working knowledge of core pharmaceutical disciplines, including clinical development, regulatory affairs, manufacturing, translational medicine and intellectual property.
- Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision making with both internal colleagues and vendors, particularly in a startup environment.
- Excellent technical writing, oral, presentation, and interpersonal communication skills.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Experience with Microsoft Project is a plus
Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.Fore Bio provides equal employment opportunities (EEO) to all employees and applicant for employment without regard to religion, race, creed, color, sex orientation, national origin, age, marital status or any other characteristic protected by applicable federal, state, or local law.
