Associate Director, Regulatory Project Management & Operations

Fore Biotherapeutics US Inc•Philadelphia, PA

33d

About The Position

Fore Biotherapeutics is seeking an experienced and highly motivated regulatory project management professional to support the Registration & Launch of plixorafenib, an investigational, orally available, small molecule selective inhibitor of mutated BRAF. The AD, Regulatory Project Management & Operations will work alongside the Regulatory and Launch Readiness team to translate regulatory and Launch strategy into project plans. This will include providing project management support for registration submissions, planning of launch and commercial activities, including 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. This position will develop and implement Regulatory project plan and ensure integration and alignment of deliverables within the Fore end-to-end program plan.

Requirements

BS, BA or equivalent in life sciences or health-related field and at least 8 years of relevant industry experience. PMP certification is a plus.
Proven experience with FDA Center for Drug Evaluation and Research (CDER) protocols and guidelines as well as overall understanding and knowledge of IND application filing process.
Experience with mid to late-stage clinical program management across all functions
Demonstrated experience in supporting programs through NDA submission and commercial launch
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.
Experience with Microsoft Project is a plus
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.

Nice To Haves

PMP certification is a plus.
Oncology experience preferred.
Experience with Microsoft Project is a plus

Responsibilities

Collaboratively partner with cross functional team members from key functional areas including Regulatory, Business Development, Commercial Launch, Quality, Clinical and Safety to develop and execute integrated registration and launch project plan in alignment with end-to-end program plans.
Maintain cross-functional project plans, in collaboration with each functional lead, and provide routine updates on performance to plan to be included in dashboards to leadership.
Responsible for driving collaboration for the development of the overall Regulatory, BD, and Launch strategy, including documentation and communication of decisions, actions, and risks.
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 (including decisions, risks, next steps) 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) and ensure positive team spirit and high functioning team.
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.
Synthesize numerous sources of data and key analysis translating into specific actions to support company strategy.
Participate in development of Project Management tools, templates and processes. Implement best practices and tools across teams e.g., project initiation meetings, resource capacity planning, risk management, team performance, and timeline development.
Responsible for managing regulatory files and coordinating regulatory operations (plans for regulatory filings, document publishing, transmission) with vendor.