Associate Director/Director, Clinical Compliance - Boston, United States - Verve Therapeutics, Inc.

Description

Job Description

Verve 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 individual in this role will be responsible for clinical program compliance and training as well as work to support clinical teams across the different stages of development in cardiovascular development programs. The successful candidate will be skilled at both understanding and applying global compliance regulations and processes to trials as they advance through clinical development. The position requires a collaborative partnership with cross functional team members across the organization, vendors, and clinical sites. The candidate will work to ensure the needs of the teams are addressed with a collaborative outlook and be solution oriented to ensure standards, processes, and training are fit for purpose. The Associate Director/Director of Clinical Compliance will report to the Vice President, Clinical Operations.

• Collaborate with Clinical Development to ensure all trials are conducted in compliance with global regulations, ICH/GCP and applicable business processes and practices
• Review key study documents, team workflows and trial outputs to ensure compliance, and provide guidance on remediation, training and process improvement
• Collaborate with stakeholders to manage compliance questions, and keep current with regulatory developments across the industry as well as evolving compliance best practices
• Collaborate with stakeholders to identify, mitigate and remediate negative trends, risks and quality issues across Clinical Development operations
• Support and/or lead cross-functional teams with quality issue criticality assessments, investigation, root cause analysis, CAPA development and management, and effectiveness checks
• Ensure an effective internal training program is maintained for all required compliance/regulatory training
• Collaborate with Quality to identify audit targets (clinical investigator sites, vendors, internal processes), to appropriately scope audit plans, and to ensure associated issues are escalated and remediated
• Conduct monitoring oversight visits, as appropriate
• Lead and/or provide support before, during and after regulatory inspections
• Establish, track and report on KRIs/KQIs for Clinical Development
• Other duties as assigned

• Bachelor's degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
  • Associate Director: 9+ years of experience in clinical research with direct clinical compliance oversight
  • Director: 10+ years of experience in clinical research with direct clinical compliance oversight
• Ability to identify areas for process improvement and lead discussions to implement change
• Excellent written and oral communication skills
• Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
• Good organizational skills for the management of clinical development compliance and working in a fast-paced environment
• Proficiency with word processing, spreadsheet, database, presentation software (i.e. MS Office skills such as Outlook, Word, Excel, and PowerPoint)
• Ability to collaborate with stakeholders at all levels internally and externally

Verve 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.

Verve 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.