Executive Medical Director, Clinical Development

Found in: Jooble US O C2 - 2 weeks ago


Boston MA, United States Verve Therapeutics Inc Full time

The Position

Verve is seeking a Medical Director, Clinical Development to join our team to advance highly innovative gene editing medicines for cardiovascular disease through clinical development. The successful candidate will collaborate with clinical operations to design and execute clinical studies of our gene editing medicines. The individual will represent the study through interactions with our internal teams, study investigators, key opinion leaders, and regulators. The individual will report to the Vice President of Translational Medicine and will have a highly visible position at the company. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive in a highly innovative and fast paced environment.

Job Responsibilities

* Provide medical oversight of clinical trial activities including study design, study execution, and interpretation of emerging trial data

* Contribute to the development of key study documents including the protocol and investigator's brochure

* Participate in the preparation of regulatory submissions and support responses to health authorities and ethics committees

* Engage with study investigators and medical experts as part of the development of study protocols and study conduct

* Collaborate with the research team to develop and implement a translational biomarker strategy for the program

* Represent clinical development on cross-functional study teams

* Travel to clinical sites, conferences, and regulatory meetings as needed

Qualifications

* MD or MD/PhD with a minimum of 1 year of experience directly overseeing the conduct of clinical trials, preferably in an industry setting

* Board eligible or certified in a medical specialty preferred

* Strong clinical and scientific background with experience reviewing and interpreting study data.

* Medical monitoring experience in clinical trials

* Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies

* Strong attention to detail and organizational skills

* Exceptional verbal and written communication skills

* Ability to work effectively with cross-functional teams

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