Director, Regulatory Affairs, Companion Diagnostics
Reports to: Chief Regulatory & Quality Officer
Location: Princeton, NJ
About PMV Pharmaceuticals
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting the reactivation of 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.
This strategic role has leadership responsibility for global regulatory strategy to support the development of biomarkers and companion diagnostic tests. Provides innovative approaches to resolve complex regulatory issues. In addition, collaborate with team members cross-functionally to ensure companion diagnostic development programs progress efficiently.
- Ensure global regulatory plans support a precision oncology approach (e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies
- Collaborate with internal and external team members during strategic meetings with health authorities
- Ensure compliance of programs with regulatory requirements for diagnostics and devices
- Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products
- Provide guidance on planning, writing and reviewing of key dossier documents for submissions globally
- Collaborate with Clinical Biomarker and Translational Medicine team to develop biomarker, companion diagnostics and other devices to optimize access to patients
- Remain on the forefront of the relevant science, competitive landscape and policy, including detailed competitive intelligence and their application to the regulatory process
- Bachelor's degree in Life/Health Sciences required; Master’s Degree, Pharm.D, or Ph.D preferred
- Strong scientific background (e.g. molecular biology) – a plus
- Minimum of 5 years of experience in regulatory affairs and diagnostic related development
- Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals
- Extensive experience developing companion diagnostics and devices
- Experience with drug development and drug regulatory procedures.
- Understanding of strategic and tactical roles and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and corporate objectives
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to appropriate stakeholders
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.