Position Summary:
We are looking for a Sr. Director, Clinical Operations to lead and oversee all aspects of our clinical operations programs and will report to the Head of Clinical Development. This individual will be responsible for all areas related to planning and execution of the operational strategy of our clinical trials. The ideal candidate will have experience across multiple phases of clinical operations and will be excited about the opportunity to make a huge impact in an actively growing company.
Key Responsibilities:
- Be accountable for end-to-end clinical operations strategy, good clinical practice, adherence to regulatory standards, site and regulatory authority clinical operations documents and interactions, and clinical trial CRO selection and oversight.
- Lead the CRO/vendor selection strategy to support assigned studies, oversee documentation for the contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies.
- Develop standard operating procedures, establish staffing and resourcing needs, and ensure the efficient delivery, transfer, and reporting of high-quality, source-verified clinical trial data.
- Present Clinical Operations strategy and updates to senior leadership.
- Successfully establish strong relationships, working in partnership with key stakeholders across Terremoto.
- Be accountable for budgeting, forecasting, and overall management of clinical budgets.
- Supervise, coach, mentor, and hire new staff as appropriate.
- Proactively identify risks and develop and implement mitigation strategies.
Qualifications:
- Strong leadership, influence, and tactical execution skills and experience.
- Strong working knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations.
- Excellent interpersonal skills with a demonstrated ability to effectively work with internal and external cross-functional groups.
- Demonstrated ability to collaborate effectively in cross-functional teams, to lead and develop a high-performing team and to mentor team members at all levels.
- Possesses excellent business and financial aptitude, is highly analytical and uses data to drive business and continuous improvements.
- Proven track record of successful clinical trial execution, including experience with Phase I-III trials.
Education:
- Bachelor’s degree or higher in a relevant field, preferable related to biological or life science.
- 10+ years of relevant trial leadership experience in either sponsor or CRO.
Travel:
- Ability to travel 25%, may occasionally be more.
* The anticipated salary range for candidates who will work in South San Francisco, CA is $270,000 to $285,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
