Director, Clinical Science

Position Summary:

The Director of Clinical Science will work closely with the Executive Medical Director and SVP/Head of Clinical Development to implement clinical strategies for one or more development programs. This includes leading the direction, planning, execution, and interpretation of clinical trials while maintaining patient safety and data integrity. 

Key Responsibilities:

• Contributing to or leading the development of clinical protocols, informed consents and other study related materials
• Drafting clinical sections of study reports, investigator brochures, responses to regulatory authorities and other key clinical and regulatory documents
• Ensuring high quality clinical trial conduct and data collection (e.g. safety, efficacy data) through on-study clinical data monitoring
• Partnering with clinical operations and other teams for successful execution of clinical studies
• Working closely with medical monitor on clinical activities, monitoring the safety of trials, and clinical site interactions
• Reviewing and analyzing clinical data
• Engaging in topical literature review on discrete topics to support development program success.
• Representing clinical science on cross functional teams
• Collaborating with clinical trial sites and investigators
• Presenting scientific information (clinical trial design, study data) to internal and external stakeholders
• Other duties as assigned

Qualifications:

• Demonstrated experience in protocol authoring, study startup, study execution/monitoring and data review activities
• Experience contributing to global regulatory filings such as INDs or CTAs
• Skilled in scientific data analysis, interpretation, and results reporting
• Experience successfully advancing small molecule drugs from preclinical to clinical
• In-depth knowledge of regulatory requirements governing drug development
• Ability to work successfully in a cross-functional environment and drive outcomes
• Must be solution oriented with demonstrated skills to innovate, solve problems, and foster a collaborative working environment
• Excellent written and oral communication skills
• 5+ years of relevant experience

Education:

• BS/MS degree (science based) is required with PharmD, PhD, MD preferred

Travel:

• Ability to travel 15-20%, occasionally more.

* The anticipated salary range for candidates who will work in South San Francisco, CA is $225,000 to $250,000. 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