Job Opportunities

Clinical Trial Manager

Reports to: VP Clinical Operations

About PMV Pharmaceuticals

PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.

Job Description: Manage and oversee PMV’s clinical studies according to US FDA regulations, the study protocol(s), and company objectives (time and budget)

Responsibilities

  • Plan, manage, oversee and thoroughly document the conduct of PMV clinical studies, including CRO and vendor management
  • Ensure PMV clinical studies are conducted in accord to governing SOPs 
  • Ensure PMV clinical studies are implemented according to the study protocol, in compliance with FDA regulations (CFR), ICH GCP, and local regulations, and with company policies and procedures as applicable 
  • Collaborate with all (internal and external) team members for the planning and execution of clinical studies 
  • Author/provide input into study related documents including clinical study protocols, ICFs, eCRFs, Monitoring Plans, other study plans, instructions and documents 
  • Facilitate CRO, vendor, and site selection decisions as applicable 
  • Develop study oversight plans and facilitate the collection of oversight documentation to maintain inspection ready 
  • Oversee and manage project timelines and budgets; ensure project deliverables are acceptable according to objectives and are met on time and within budget 
  • Proactively lead in the identification and management of clinical study risks (risk mitigation) and issues (with proposed solutions) 
  • Regular reporting of study status and execution, including overall updates, risks, and issues as identified or experienced 
  • Collaborate with legal (and others, as needed) on clinical contracts and agreements (e.g. confidentiality agreements, vendor contracts, and clinical trial agreements with sites) 
  • Monitor and visit clinical study sites as needed (co-monitor or independently)
  • Contribute to department documentation development, such as Standard Operations Procedures (SOPs) 

Qualifications

  • Bachelor’s degree or higher 
  • 3-5 years working on drug development at a biotech/pharma company or CRO 
  • 2-3 years managing clinical trials as the trial Sponsor including experience overseeing CROs
  • Working knowledge of ICH GCP regulations and clinical protocols
  • Experience monitoring clinical study sites highly preferred (i.e. having independently conducted SQV, SIV, IMV, and COVs)
  • Experience with oncology / rare disease highly preferred
  • Experience on all phases of clinical study (I-III) preferred
  • Global experience preferred 

Attributes

  • Highly motivated 
  • Responsible/accountable 
  • Detailed oriented with a view to overall scope of the project 
  • Strong interpersonal, organizational, and multi-tasking skills; attention to detail
  • Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency

How to Apply

To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com.


PLEASE, NO PHONE CALLS or AGENCIES

PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.