Sr. Director, Clinical Development
Reports to: VP, Clinical Development & Medical Affairs
Location: Hybrid: Remote/Princeton, NJ
Oversees the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and determines study completion. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors.
- Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy
- Routinely represents the assigned molecules/products in cross-functional steering and /or governance committees.
- Lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
- Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
- Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting
- Serves as the lead for communications, both written and oral, with health authorities.
- Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, as well as drug safety surveillance in collaboration with the Head of Safety.
- Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
- May directly manage or delegate and oversee the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.
- May assist in the clinical evaluation of business development opportunities.
- Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for assigned molecules /products.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as PMV SOPs.
- MD or equivalent with 8-10 years' clinical development experience in the biopharma industry, healthcare or a related environment.
- Board certification in Oncology is preferred, including familiarity with clinical solid tumor.
- Multiple years' experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia.
- Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
- Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
- Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting or academia.
Knowledge & Other Requirements
- Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.
- Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.
- When needed, ability to travel.
- PMV provides 100% employee covered medical benefits, a generous PTO policy, competitive salaries, equity options, Employee Stock Purchase Plan, Employee Referral Program, and much more.
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.