Associate Director, Clinical Operations

Position Summary:

We are looking for an Associate Director, Clinical Operations to lead and execute the clinical operational strategy of Terremoto clinical trial(s). This role will be responsible for study team delivery focusing on study planning/start-up, execution, quality data delivery- cleaning to lock, & close-out with an inspection readiness mindset reporting to the Executive Director, Clinical Operations. 

Key Responsibilities:

• Cross-functional study team leadership role; coordinating/ partnering with key internal/external stakeholders related to all aspects of clinical trial operations.
• Accountable for the delivery of assigned clinical program/studies; driving overall study strategy/plan/timelines/delivery in support of the Clinical Development Plan.
• Proactively implements risk mitigation strategies, escalating issues as appropriate.
• May review and provide clinical operations input into relevant clinical documents such as protocol, investigator brochure, regulatory documents, & clinical study reports.
• Assist in study and system set-up providing operational expertise to other trial-related documents/ systems (i.e., informed consent, essential documents, CTMS/ EDC/ IRT).
• Accountable for all clinical operations/oversight plans; documenting Sponsor oversight of outsourced clinical activities.
• May liaison/ interface with clinical investigators/site staff.
• May prepare/support the review of budget/ negotiations with clinical sites, as necessary.
• Prepares updates on study progress to Terremoto Senior Leadership, as necessary. 
• Oversee/collaborates on inspection readiness activities that support audit/regulatory inspections related to clinical trial conduct.
• Accountable for Trial Master File (TMF) completeness.
• May participate in process improvement/ clinical operations SOP development.
• Delegating/ mentoring to junior level clinical operations personnel.
• Other clinical operations activities as required.

Qualifications:

• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively in a cross- functional environment.
• Ability to prioritize/multi-task and adjust based on changing priorities.
• Attention to detail, excellent time management, and organizational skillset required.
• Comfortable in a fast-paced small biotech company environment.
• Previous Clinical operations experience at a small or mid-size company preferred.
• Global Oncology experience preferred.
• Strong knowledge in clinical trials, ICH/GCP, and regulatory requirements.
• Computer skills including proficiency in the use of Microsoft Word, Excel, and PowerPoint.

Education:

• Bachelor’s degree or higher in a scientific or health care field preferred.
• 8 years of relevant trial leadership experience within pharma/biotech preferred, will consider CRO experience.

Travel:

• Ability to travel ( ~ estimate 15-20%)

* The anticipated salary range for candidates who will work in South San Francisco, CA is $190,000 to $215,000. 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. #LI-DNI

Salary : $190,000 - $215,000