Custodial Operations Manager
Navia Benefit Solutions, Inc.
Director, Medical Affairs Strategy and Operations
Day One Biopharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $230,000 - $250,000 per year
Job Level
Lead
About the role
- Act as strategic thought partner to VP, Medical Affairs, supporting leadership of Medical Affairs Leadership Team (MA-LT) operations and cross-functional alignment.
- Lead Medical Affairs strategic and tactical planning cycles (annual functional plan, Integrated Evidence Generation Plan (IEGP), publications, scientific communications plan, etc.).
- Drive strategic initiatives to evolve Medical Affairs (e.g., Med Affairs 2.0, upskilling field teams, process optimization).
- Integrate insights from internal and external sources into strategic recommendations and portfolio decision-making.
- Oversee Medical Affairs budget and resource allocation in partnership with Finance, ensuring alignment with Program Team (PT) and corporate goals.
- Develop and manage functional dashboards, Key Performance Indicators (KPIs), and operational metrics to measure impact and enable informed decision-making.
- Ensure inspection readiness and adherence to regulatory/compliance standards across Medical Affairs deliverables.
- Provide operational leadership for Investigator Sponsored Trials (ISTs), Compassionate Use Program (CUP)/ Expanded Access Program (EAP), Continuing Medical Education (CME) grants, congress operations, and (Key Opinion Leader) KOL engagement.
- Manage vendor relationships, contracting operations, Fair Market Value (FMV) processes, and Needs Assessment Form (NAF) navigation.
- Oversee functional financial operations (bills, tracking, vendor oversight).
- Ensure systems, tools, and shared repositories are well-maintained and consistently utilized.
- Coordinate internal Medical Affairs meetings, logistics for congresses, and KOL engagement scheduling.
- Support execution, documentation, and reporting for ISTs, CUP, and grants/sponsorships.
- Share best practices across Medical Affairs to improve efficiency and standardization.
Requirements
- Bachelor’s degree required (preferably in a healthcare-related, scientific, or business discipline); advanced training in project management preferred.
- Minimum 10+ years of experience in Medical Affairs operations or related functions within the pharmaceutical/biotech industry, with at least 5 years in a leadership capacity
- Proven success in leading Medical Affairs programs and projects and an ability to manage and develop teams, including direct reports and external contractors.
- Demonstrated experience in project management, budget oversight, and process optimization in in a dynamic, fast-paced environment.
- Expertise in managing operational systems, metrics reporting, and budget oversight.
- Experience managing external collaborations and overseeing vendor relationships, contracts, and FMV processes.
- Strong understanding of compliance, regulatory, and inspection readiness requirements for Medical Affairs.
- Excellent organizational, strategic thinking, and communication skills.
- High degree of integrity and commitment to compliance and quality.
Benefits
- Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementbudget oversightprocess optimizationmetrics reportingoperational systems managementstrategic planningKPI developmentvendor managementcontract managementregulatory compliance
Soft skills
strategic thinkingorganizational skillscommunication skillsleadershipteam managementintegritycommitment to compliancecollaborationproblem-solvingadaptability
Certifications
Bachelor's degreeadvanced training in project management
