Director, Clinical Operations
South San Francisco, CA, USA
Posted on Tuesday, August 22, 2023
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.
The Director, Clinical Operations is responsible for the overall management and successful execution of one or more clinical trials. The AD/Dir oversees CROs and third party vendors and closely collaborates with cross-functional internal and external stakeholders to ensure adherence to GCPs, SOPs, and FDA/ICH guidelines and delivery of high quality data within the defined timelines and budget.
- Serves as the operational lead and responsible for the overall management of one or more clinical trials
- Provides leadership and direction to study teams to meet corporate goals and in accordance with the Clinical Development Plan
- Day to day study management including oversight of CRO, study vendors, and investigational sites to ensure high quality study execution and data delivery within the defined timeline and budget
- Evaluates vendor performance, assess risks, and serves as point of escalation
- Maintains study dashboards and reports study metrics, risks, and mitigations to leadership
- Represents Clinical Operations and/or the study team at Study Management Team, Core Team, and Portfolio Team meetings
- Develops strong cross-functional partnerships and routinely collaborates with multiple departments including translational science, regulatory, quality, supply chain, etc
- Contributes to the clinical sections of regulatory applications, such as preIND, IND, NDA/BLA.
- Contributes to the development of core study documents, such as the study protocol, IB, ICF, Pharmacy Manual
- Mentors and provides line management to junior colleagues
- BA/BS in a relevant scientific discipline or equivalent degree. Advanced degree preferred
- 10+ years of clinical research experience in the biotech, CRO, or pharmaceutical industry
- 5+ years of experience managing multi-center clinical trials. Experience managing CROs, clinical study vendors, investigational sites, and internal study teams
- 3+ years of people management experience
- Early phase oncology experience is preferred
- Prior investigational site experience, CRO monitoring experience, and experience working within a small biotech company are valued
- Expert knowledge of ICH/GCP, drug development, and clinical research industry practices
- Strong leadership and complex project management skills
- Strong oral/written communication and presentation skills
- Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors, and investigational sites
- Organizational skills, with a detail-oriented nature. Demonstrates accuracy and thoroughness. Looks for ways to improve and promote quality
- Must be able to work in a fast-paced, early phase environment with demonstrated ability to prioritize and execute competing tasks and demands
- Occasional domestic and international travel may be required
Salary and Benefits:
- Compensation for this role includes base salary, annual target bonus and equity
- The base salary range for this role is $215,000 - $230,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
- Significant growth opportunity as the company expands
- Empathetic, supportive and collaborative colleagues and work environments
Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.
We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.