- Partners with other clinical scientists and medical monitor on oversight of clinical trial activities, including safety reviews and site interactions
- Organize and lead process for review of potential patients for study participation
- Review, analyze, and interpret emerging clinical trial data
- Liase with the broader clinical development team at Verve (clinical operations, data management, and regulatory teams)
- Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals)
- Leads internal meetings to review topics and develop mitigation plans
- Contribute to the development of presentations emerging from clinical studies
- Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and Verve SOPs
- Other duties as assigned
- Healthcare degree required such as RN, NP, PA, BSN, MSN, Pharm D
- 7+ years of clinical healthcare experience with a BS level degree
- 5+ years of clinical healthcare experience with an advanced degree
- Experience ideally in internal medicine or cardiology.
- Experience with clinical research studies or clinical development experience in industry is preferred.
- Familiarity with key clinical study documents
- Experience with the review of clinical data
- Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
- Experience working with CROs and external vendors not required but a plus
- Strong attention to detail and organizational skills
- Exceptional verbal and written communication skills
- Ability to build strong relationships and work effectively with cross-functional teams
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Senior Clinical Scientist - Boston, United States - Verve Therapeutics, Inc.
Description
Job Description
Job DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.
The PositionVerve is seeking an experienced Senior Clinical Scientist to join our team as we continue to advance gene editing medicines for cardiovascular disease into clinical development. In this position, you will be an integral part of the clinical development team supporting the execution of early phase clinical studies. You will report to the Senior Director, Clinical Research. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast paced environment.
Job ResponsibilitiesVerve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & Staffing AgenciesVerve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.
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