Job Description

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

The Associate Director of Medical Affairs Operations is accountable for oversight of day-to-day operations within Medical Affairs, ensuring efficiency, compliance, and seamless execution across key programs and initiatives. The Associate Director of Medical Affairs Operations provides critical project management support for investigator-initiated studies, early access programs, grants, congresses, advisory boards, financial operations, and systems/tools.

Major Duties / Responsibilities

• Operational oversight: Lead day-to-day Medical Affairs Operations, ensuring smooth execution across programs and initiatives. Streamline processes and enable efficient ways of working across Medical Affairs.
• Investigator-initiated research and early access: Oversee operational processes for investigator-sponsored trials and early access programs. Regular interaction with sites and investigators, vendors, and internal stakeholders including Regulatory Affairs, Pharmacovigilance, Global Supply Chain, and Clinical Development. Track progress and milestones and provide cross-functional updates.
• Grants & sponsorships: Serve as coordinator for the Grants Review Committee, managing intake of medical education grant requests. Organize review committee meetings, agendas, and decisions. Collect and analyze post-event outcome reports, manage medical education dashboards, and ensure accurate reporting. Support RFP development and manage externally facing intake portal. Manage logistics, tracking, and reporting for symposia, sponsorships, and CME programs.
• Congresses: Support medical congress planning and execution including booth and tabletop logistics, KOL engagement, and cross-functional coordination.
• Advisory boards: Support advisory board planning, contracts, and operational execution. Oversee KOL logistics and contract execution, where needed.
• Financial operations: As needed, manage contracts, purchase orders, invoicing, and financial tracking. Deliver financial reporting versus plan, ensuring transparency and accountability.
• Centralized knowledge management: Oversee centralized document management systems to ensure proper storage, organization, and accessibility of Medical Affairs materials. Maintain document repositories, version control, and archiving processes to support compliance and operational efficiency.
• Reporting: Develop and maintain medical dashboards and calendars to track activities and performance. Provide clear reporting to leadership on operational metrics and outcomes.
• For all responsibilities, ensure operational readiness, compliance, timeliness, and alignment with Medical Affairs strategy and objectives.
• Assist with the writing and development of SOPs related to the aforementioned areas, ensuring compliance with regulations and local laws, while maintaining clear instructions for procedures and activities.
• Lead training of new and existing team members on internal systems.

Skills, Abilities & Competencies

• Operationally disciplined with strong attention to detail and problem solving
• Skilled in cross-functional collaboration and stakeholder engagement
• Strong financial acumen and reporting capabilities
• Effective communicator with ability to synthesize complexity into clear, actionable insights
• Committed to continuous improvement and compliance
• Knowledge of anti-kickback statute, Sunshine Reporting, and PhRMA Code
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements for investigator-sponsored trials
• Strong clinical study management skills
• Ability to work independently on routine assignments, or under supervision on new assignments

Required Education and Professional Experience

• Bachelor's degree required, preferably in a scientific discipline
• Minimum of 8 years of experience in relevant roles in the pharmaceutical industry and significant knowledge of Medical Affairs and drug development
• Experience managing clinical studies

Preferred Education and Experience

• Advanced degree preferred
• Prior oncology experience preferred
• An equivalent combination of relevant education and applicable job experience may be considered

Other Duties

Please note this is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working outside of these hours and may extend to evenings and weekends as business needs require.

Work Environment

This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.

Travel

The role requires infrequent travel. Travel may be required for meetings and/or conferences, up to 15%.

Physical Demands

This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds.

Compensation Range

The salary range for this role is $190,000 - $220,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

#LI-Remote

Puma Biotechnology Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, status as a protected veteran, or any other characteristic protected by law.

Job Tags

Full time, Contract work, Work at office, Local area, Remote work, Home office, Monday to Friday, Weekend work, Afternoon shift

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