Senior Director, ( MD) Global Development Lead, Early Development
Pfizer
Senior Director, Global Regulatory Affairs
Enliven Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $270,000 - $330,000 per year
Job Level
Senior
About the role
- Leads project teams in implementing and delivering the regulatory strategy across multiple early and/or late-stage programs
- Develop Regulatory Strategy for complex programs in oncology
- Participates in cross-functional teams as regulatory project lead, providing regulatory strategic guidance and support
- Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans
- Drives health authority interactions, including planning, briefing material development, and meeting preparation leadership
- Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises Development Teams accordingly
- Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
- Partners with external vendors in support of regulatory document preparation and submission
- Leads and executes non-project regulatory activities
- Demonstrates capability and credibility in complex, business critical projects as well as ability to cope with ambiguity and manage key stakeholders.
Requirements
- MD/DO degree with 5+ years of drug development experience, with 3+ years acting as a safety medical monitor in industry
- Board certification in oncology is preferred
- Demonstrated expertise in medical evaluation and safety surveillance, ideally in nephrology or immunology therapeutic areas
- In-depth understanding of pharmacovigilance data, including clinical and post-marketing safety information
- Well-versed in global drug safety regulatory frameworks, including ICH guidelines, 21 CFR, and EU GVP requirements for investigational products
- Hands-on experience with safety data analysis, MedDRA coding, and adherence to international PV standards and practices
- Highly organized and adaptable, with strong written and verbal communication skills
- Proven ability to manage cross-functional collaborations, lead discussions on safety strategy, and resolve complex patient safety concerns
- A “can do” attitude and ability to operate in a fast-paced startup environment
Benefits
- $270k - $330k. A discretionary annual bonus may be available based on individual and Company performance.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategydrug developmentsafety medical monitormedical evaluationsafety surveillancepharmacovigilance datasafety data analysisMedDRA codingregulatory applicationsregulatory document preparation
Soft skills
strong written communicationstrong verbal communicationorganizational skillsadaptabilitycross-functional collaborationstakeholder managementproblem-solvingleadershipability to cope with ambiguitycan do attitude
Certifications
MD degreeDO degreeboard certification in oncology
