We are seeking a highly motivated individual to join TP Therapeutics as a Director, Clinical Operations reporting into the VP of Clinical Operations. The Director, Clinical Operations will support the clinical development programs for the investigational lead drug candidates in company sponsored and/or investigator-sponsored trials.
As a key member of the Clinical Operations team, the successful candidate will work closely with the Vice President of Clinical Operations and will provide leadership, project management, and oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions.
This position also provides an opportunity to join a growing organization and contribute substantially to how the company will operationalize oncology trials in the future. In addition, there is an opportunity to expand your knowledge through day-to-day activities and close interactions with the Medical, Translational Sciences, Research and Discovery teams within TP Therapeutics.
- Align with the VP of Clinical Operations on strategy for successful implementation and execution of TP Therapeutics clinical trials.
- Manage and drive excellence in the overall clinical operational activities for multiple clinical trials. Also responsible for CRO selection, efficiencies and oversight, to ensure quality conduct of trials and data integrity.
- Provide functional expertise for Clin Ops strategies and tactical implementation of the studies by managing timelines, deliverables, budget forecasting, etc.
- Oversee the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management, site/country selection, etc.
- Consistent with Safety Management Plan (SMP), perform and document regular review of individual subject safety data and performs review of cumulative safety data in collaboration with the Medical Monitor.
- Develop a Data Management Plan (DMP) with CRO and cross functional team members within Medical, Data Management and Statistics.
- Ensure oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution.
- Provide Senior Management with timely updates on progress (including any changes in scope, schedule, and resources across the program).
- Depending on experience may contribute to or may independently design protocols and/or amendments.
- Depending on experience, may contribute to or be primarily responsible for formulation of a Clinical Development Plan (CDP).
- Develop site recruitment, enrollment and engagement strategies for all clinical trials.
- Collaborate with cross functional team members to prepare strategy presentations, present and discuss data at relevant meetings, external consultants, KOLs and potentially regulatory meetings as well as author sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
- Ensure effective communications to internal and external stakeholders through meetings, presentations, and other methods. Manage content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed.
- Participate in resource prioritization to ensure department and corporate goals and milestones are achieved.
- Collaborate with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits.
- May hold line management responsibilities, including hiring talent, performance development, and mentoring.
- Influence and lead ClinOps and cross functional team members to deliver quality results in a timely manner.
- Demonstrate experience with GCP and the ability to develop and apply internal policies and SOPs. Evaluate, recommend, and present standard practices and process improvements for TPT clinical trial implementation.
- Advanced scientific degree preferred (PhD, PharmD, MA); Degree in Life Sciences preferred.
- Alternatively, B.A/B.S. plus 10+ years in relevant experience.
- Experience considered relevant includes clinical or basic research in a Biotech, Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
- Demonstrated experience in oncology drug development; familiarity with related disciplines (biostatistics, regulatory, data management, safety, QA).
- Excellent organizational and leadership skills with strong experience in executing all phases of clinical trials.
- Demonstrated scientific writing and strong communication skills.
- Some travel may be required; approximately 20% travel.
EEO & Employment Eligibility
- 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.
To apply, please submit your resume to firstname.lastname@example.org