Associate Director, Medical Affairs Operations - Remote Position
Puma Biotechnology, Inc.
July 02, 2026
Remote
United States
Operations
Major Duties / Responsibilities
- Operational oversight: Lead day-to-day Medical Affairs Operations; streamline processes and enable efficient ways of working.
- Investigator-initiated research and early access: Oversee operational processes for investigator-sponsored trials and early access programs; coordinate with sites/investigators, vendors, and internal stakeholders; track milestones and provide cross-functional updates.
- Grants & sponsorships: Coordinate Grants Review Committee intake/review; manage meetings/decisions; collect/analyze post-event outcomes; manage medical education dashboards and accurate reporting; support RFP development and an externally facing intake portal; manage logistics/tracking/reporting for symposia, sponsorships, and CME programs.
- Congresses: Support planning/execution including booth/tabletop logistics, KOL engagement, and cross-functional coordination.
- Advisory boards: Support planning, contracts, and execution; oversee KOL logistics/contract execution as needed.
- Financial operations (as needed): Manage contracts/POs/invoicing; financial tracking; deliver reporting vs. plan.
- Centralized knowledge management: Oversee document management systems (storage, organization, accessibility, repositories, version control, archiving).
- Reporting: Develop/maintain medical dashboards and calendars; report operational metrics/outcomes to leadership.
- Ensure operational readiness, compliance, timeliness, and alignment with Medical Affairs strategy.
- Assist with SOP writing/development for these areas.
- Lead training of new/existing team members on internal systems.
Skills, Abilities & Competencies
- Operational discipline, attention to detail, problem solving
- Cross-functional collaboration and stakeholder engagement
- Financial acumen and reporting
- Clear, actionable communication; synthesize complexity
- Continuous improvement and compliance
- Knowledge of anti-kickback statute, Sunshine Reporting, PhRMA Code
- Knowledge of GCP, ICH guidelines, and regulatory requirements for investigator-sponsored trials
- Strong clinical study management skills
- Ability to work independently on routine assignments
Required Education And Professional Experience
- Bachelor’s degree (preferably scientific)
- Minimum 8 years pharmaceutical industry experience with Medical Affairs/drug development
- Experience managing clinical studies
Preferred Education And Experience
- Advanced degree
- Prior oncology experience
Compensation (if included)
- Salary range: $190,000–$220,000 per year
- Annual bonus target and robust benefits package
- Operational oversight: Lead day-to-day Medical Affairs Operations; streamline processes and enable efficient ways of working.
- Investigator-initiated research and early access: Oversee operational processes for investigator-sponsored trials and early access programs; coordinate with sites/investigators, vendors, and internal stakeholders; track milestones and provide cross-functional updates.
- Grants & sponsorships: Coordinate Grants Review Committee intake/review; manage meetings/decisions; collect/analyze post-event outcomes; manage medical education dashboards and accurate reporting; support RFP development and an externally facing intake portal; manage logistics/tracking/reporting for symposia, sponsorships, and CME programs.
- Congresses: Support planning/execution including booth/tabletop logistics, KOL engagement, and cross-functional coordination.
- Advisory boards: Support planning, contracts, and execution; oversee KOL logistics/contract execution as needed.
- Financial operations (as needed): Manage contracts/POs/invoicing; financial tracking; deliver reporting vs. plan.
- Centralized knowledge management: Oversee document management systems (storage, organization, accessibility, repositories, version control, archiving).
- Reporting: Develop/maintain medical dashboards and calendars; report operational metrics/outcomes to leadership.
- Ensure operational readiness, compliance, timeliness, and alignment with Medical Affairs strategy.
- Assist with SOP writing/development for these areas.
- Lead training of new/existing team members on internal systems.
Skills, Abilities & Competencies
- Operational discipline, attention to detail, problem solving
- Cross-functional collaboration and stakeholder engagement
- Financial acumen and reporting
- Clear, actionable communication; synthesize complexity
- Continuous improvement and compliance
- Knowledge of anti-kickback statute, Sunshine Reporting, PhRMA Code
- Knowledge of GCP, ICH guidelines, and regulatory requirements for investigator-sponsored trials
- Strong clinical study management skills
- Ability to work independently on routine assignments
Required Education And Professional Experience
- Bachelor’s degree (preferably scientific)
- Minimum 8 years pharmaceutical industry experience with Medical Affairs/drug development
- Experience managing clinical studies
Preferred Education And Experience
- Advanced degree
- Prior oncology experience
Compensation (if included)
- Salary range: $190,000–$220,000 per year
- Annual bonus target and robust benefits package