Associate Medical Affairs Operations Director

Exelixis • Alameda, CA

80d • $185,000 - $261,500

About The Position

The Associate Medical Affairs Operations Director plays an integral role in supporting the Medical Affairs Operations team. This position provides operational and scientific support of key initiatives to ensure their successful implementation. The Associate Medical Affairs Operations Director contributes to key aspects of the investigator sponsored trial (IST) program and is responsible for activities associated with the activation, tracking, and reporting of study-related information. This role provides an outstanding opportunity to work in a cross-functional environment. This role interfaces with Regulatory Affairs, Global Clinical Supply Chain, Drug Safety, Information Technology, Compliance and Legal departments. Strong communication skills, attention to detail, and the ability to learn and master skills are essential to success. Opportunities for direct ownership over key business processes may be provided to outstanding performers.

Requirements

• Bachelors in a scientific discipline or equivalent degree with a minimum of 11 years of relevant clinical, scientific and/or industry medical affairs.
• Experience in Oncology strongly preferred.
• Experience working in clinical trial development, research management, and/or investigator-initiated research programs.
• Experience working with a Medical Affairs research program preferred.
• Familiarity with clinical research terminology required.
• Direct experience with oncology clinical trials preferred.
• Strong analytical and organizational skills with the ability to focus on detailed information preferred.
• Strong project management skills preferred.
• Strong written and verbal communication skills required.
• Ability to provide strategic oversight while managing or overseeing day to day activities on many diverse projects.
• Ability to work with both internal and external customers to implement action plans.

Nice To Haves

• Possess exceptional communication skills, both oral and written with the ability to influence internal and external stakeholders.
• Possess excellent organizational/time management skills and be able to collaborate and align with diverse, cross-functional teams.
• Ability to work well independently and in teams as necessary.
• Demonstrates change agility, maintaining a positive attitude, anticipating and proactively adapting actions to seize opportunities during times of rapid change and/or uncertainty.
• Ability to work well under pressure.
• Strong analytical skills.
• Advanced MS Office skills required.

Responsibilities

• Provide strategic leadership and tactical management to global medical affairs programs as it relates to research management, process, cross-functional operational integration, and forward-looking operational planning.
• Lead, interact, collaborate and integrate processes with functional area peers within Medical Affairs, Clinical Development, Drug Supply, Regulatory, Translational Research, Compliance and Legal to activate studies in a manner consistent with relevant SOPs and processes.
• Provide operational expertise and support for the Investigator Sponsored Trial (IST) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements.
• Maintain Med. Affairs Operations internal assets/records and develop reports as needed.
• Ensure all IST program records are kept up to date and accessible for team use and audit-readiness.
• Evaluate and execute solutions to address operational unmet needs within Medical Affairs Operations.
• Assist with the budget negotiation process for Medical Affairs Operations projects, including Fair Market Value (FMV) assessment for all IST budgets and amendments.
• Facilitate work to define or refine related processes, where necessary.
• Work with Legal Department and business partners to develop and negotiate payment schedules for ISTs and other Medical research projects.
• Review and assist in the writing or revision of department or cross functional process manuals.
• Evaluate and confirm all IST invoices as per company policy and perform payment assessments required for budget reconciliation upon IST closure or IST amendment.
• Support IST activation workflow in accordance with the IST SOP and defined business processes.
• Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams.
• Assist with other duties related to the Medical Affairs Operations function.

Benefits

• 401k plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Opportunity to purchase company stock.
• Long-term incentives.
• 15 accrued vacation days in the first year.
• 17 paid holidays including a company-wide winter shutdown in December.
• Up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees