Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
We are looking for an experienced Director for our Program Management Team. The successful candidate will be responsible for planning and support of global registration for our lead oncology asset Repotrectinib in multiple indications. This person will work closely with the project team members representing preclinical, clinical, regulatory, and operations, CMC, quality, legal departments in a team environment to develop concise strategic development proposals, integrated project plans, and manage and track key project deliverables. This person will also provide regular project updates to Senior Management.
DUTIES AND RESPONSIBILITIES:
- Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification of resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation.
- Manage Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions (meeting minutes).
- Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities.
- Work closely with and build strong working relationships with cross-functional team members and external vendors to develop a collaborative team environment and manage timelines for regulatory submissions (IND/NDA/BLA/MAA, etc.).
- Assists in the review of project team regulatory documents and SOP revisions, if relevant.
DESIRED SKILLS AND EXPERIENCE:
- BS in a scientific field required; Master’s degree preferred.
- Strong understanding of Drug Development process and US and EU Regulatory requirements.
- Experience with NDA/BLA submissions required: experience with global registration is a plus.
- Minimum of 8+ years of project management experience in drug development
- Exposure to late-stage programs (Phase II/III pivotal) essential; and exposure to early-stage programs (pre-clinical through Phase I/II proof-of-concept) a plus.
- Able to work independently and creatively with minimal oversight
- Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
- Strong ability to proactively predict issues and solve problems, identify risks.
- Strong ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
- Proven ability to balance the strategic needs of the program with tactical day-to-day activities.
- Excellent people (soft) skills, conflict resolution, diplomacy and positive influencing abilities.
- Outstanding communication, planning and organizational skills.
- Highly collaborative team player who fosters open communication and able to facilitate urgent needs.
- Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Microsoft Project, SmartSheet, Visio, PowerPoint and Excel, etc.).
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.