Senior Clinical Program Manager
- Expired: March 15, 2022. Applications are no longer accepted.
Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The position of Senior Clinical Project Manager (Sr. CPM) is responsible for the operational management and oversight of clinical trials, sites, and vendors within a clinical development program. The Sr. CPM works closely with the leadership of Clinical Trial Operations as well as other key cross-functional team members to ensure that Nuvation Bio delivers high-quality clinical trial data efficiently, cost-effectively, and in alignment with corporate deliverables and timelines. This role may independently manage Clinical Trial Operations resources and oversee external vendors on the execution of Nuvation Bio clinical trial protocols in a highly dynamic, growing environment. Additional accountabilities may include collaborative development of program-level operational strategy, budget projections, and day-to-day personnel management and development as needed.
You will be responsible for…
- Oversee and manage day-to-day clinical trial activities and priorities, including leadership of Study Management Teams (SMTs) for a molecule.
- Oversee and/or directly manage the performance of key vendors, e.g., clinical research organizations (CROs), clinical laboratories, and/or contract Clinical Research Associates (CRA) to ensure that their work is conducted per protocol and per Statement of Work (SOW).
- Develop and maintain good working relationships with investigators and clinical site staff, including supporting their participation in Nuvation Bio clinical trials.
- Partner with Supply Chain management on investigational product (IP) forecasting and timelines for clinical trial protocols
- Partner with Clinical Data Management on the implementation of the EDC and IRT systems.
- Partner with a Quality representative on the development of Clinical Quality Audit Plans for each clinical trial protocol and/or program.
- Partner with Translational Medicine to ensure implementation of biomarker strategy in a clinical trial protocol(s).
- Author or contribute to key study documents, including clinical protocols and associated amendments; informed consent forms, and clinical study reports
- All other duties as assigned
What skills & experience you’ll bring to us…
- Bachelor of Science in Life Sciences in (e.g. Biology, Chemistry, Pharmaceuticals), Business Administration or related discipline or equivalent experience.
- Eight (8+) years experience managing clinical trials and/or directly applicable experience in drug development, ideally including a small, start-up environment. Oncology & Early Development experience preferred.
- Experience managing clinical trials staff directly or indirectly desirable.
- Direct, prior experience with selecting and managing global CROs and other key vendors.
- Direct, prior experience leading Study Management Teams for all phases of clinical trials including start-up, enrollment, maintenance, and close-out.
- Prior experience in managing, retaining, and developing Clinical Trial Operations resources in particular management of Clinical Trial Managers is desirable.
- Current knowledge and understanding of FDA and ICH Guidelines, including Good Clinical Practices (GCP) E6(R2) requirements.
- Able to interact and effectively influence cross-functional teams within the Development organization.
- Must be self-motivated and able to prioritize/manage a large volume of work in a dynamic, changing, growing start-up culture.
- Proficient with MS Word products and database software; experience indirectly using electronic data capture.
- Familiarity with drug development processes across all phases of development (early to late-stage).
- Travel may be required for clinical investigative site visits, vendor visits, meetings, and presentations.
What we have for you!
- Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- and much more!
Want to apply? Get in touch today
Visit us at www.NuvationBio.com/careers to view any of our current openings and apply today!
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
AddressSan Francisco, CA
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