Director / Sr Director of Clinical Strategy and Operations at Senti Biosciences
South San Francisco, CA, US
Thank you for your interest in a career at Senti Biosciences. We are seeking individuals who are passionate about the future of “smart therapeutics” and have the energy and boldness to thrive and grow in a dynamic and fast entrepreneurial environment.
 
Senti Bio is seeking a Director / Sr Director of Clinical Strategy and Operations to be the internal lead for our clinical programs. This role will be essential to the generation of development plans, trial design, trial conduct, data analysis and medical monitoring of clinical studies. Strong academic background and training is desired and the candidate will be supported by internal staff and external consultants as needed. A successful applicant will have prior hands on experience taking a novel oncology therapy through IND and early clinical trials, and be comfortable in a fast moving and nimble culture.

Responsibilities

    • Clinical Development Plan generation.
    • Define development strategy and trial design driven by target function, mechanism of drug candidate action and understanding of disease profile.  
    • Identification of clinical investigators and KOLs based on target and disease knowledge; coordination of their activities for trial conduct, advisory boards, etc.
    • Translation of trial design into protocol development, including writing and reviewing protocols/informed consents in conjunction with colleagues from other disciplines. 
    • Guidance for clinical data review, analysis and presentation (including writing and/or review of clinical study reports, abstracts, presentations and manuscripts).
    • Protocol implementation, including interactions with clinical teams. 
    • Clinical monitoring to ensure the highest standards for patient safety, trial conduct and data integrity.
    • Interaction with and support of Regulatory function to ensure timely contribution of clinical sections for IND, IB, NDA and other communications with the Agency. 
    • Timely and accurate safety reporting to regulatory authorities.
    • Program development, including cross-functional interactions with appropriate disciplines to achieve programmatic goals. 
    • Close interaction with appropriate functions to ensure that the scientific basis for targeted therapies under development and emerging data inform therapeutic strategies and biomarker exploration in current and future trials.
    • Management of external colleagues who serve in consulting roles. 
    • Interaction with regulatory authorities, as needed.

Qualifications

    • MD or MD/PhD
    • Board certification (or foreign equivalent) in oncology, hematology or equivalent 
    • Excellent verbal and written communication skills; comfortable with public speaking.
    • Strong organizational skills, including the ability to prioritize workload. Ability to work independently, with direction and within project teams. 
    • Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel.
Senti Bio is the next generation therapeutics company that designs gene circuits and programs cells for tremendous therapeutic value. Our mission is to engineer an entirely new class of medicine that will transform people’s lives by curing the most challenging diseases. We are proud to count NEA, 8VC, Amgen Ventures, Pear Ventures, Lux Capital, Menlo Ventures, Allen & Company, Nest.Bio, Omega Funds, Goodman Capital, and LifeForce Capital among their investors. Senti Bio is based in South San Francisco, CA, USA.