Associate Director, Medical Information

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

The Associate Director, Medical Information will collaborate with the Senior Director to plan, develop, coordinate, and execute Medical Information Department strategy and tactics. This includes development and maintenance of the department product knowledge database and the development of standard and custom responses to health care professional medical inquiries.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Search, review, and summarize available data in the published literature and internal documents to develop accurate, fair, and balanced responses to requests for information on Exelixis products received primarily from health care professionals.
• Oversee the Medical Information response document database through the creation, development, and maintenance of standard response letters, frequently asked questions, and cover letters
• Provide training to third party call center staff with written standard responses and Q&A documents to facilitate immediate fulfillment of requestor needs.
• Aid in the triaging of product complaints and adverse events regarding company products.
• Aid in management of the third-party US medical information call center including training and quality assurance.
• Develop data submission packages to key oncology guidelines and clinical pathways in collaboration with medical information senior director, medical directors.
• Provide vendor oversight and lead the development and creation of the AMCP dossiers (unapproved and approved use) in collaboration with senior Medical Information personnel, HEOR, Market Access, Medical, Legal, Regulatory.
• In collaboration with the Medical Information Senior Director, co-develops the agenda and leads Medical Information team meetings.
• Collect and analyze department metrics producing reports and insights.
• Contribute to execution of medical affairs activities at scientific conferences.
• Collect, analyze, and report department metrics and communicates medical insights to Medical Affairs and other departments as appropriate.
• Collaborate with Senior Director to develop, implement, and maintain best practices, standard operating procedures, policies, work instructions, technologies, etc. to maximize compliant, effective, and efficient delivery of medical information services.
• Support the medical information needs of Exelixis employees, as appropriate, including Medical Affairs, Regulatory, Clinical Development, Pharmacovigilance, Public Affairs, etc.
• Contribute to the development of the Medical Information annual and multi-year strategic and tactical plans including overall strategy and objectives.
• Collaborate with other members of the Medical Affairs organization (e.g. Medical Science Liaisons, Medical Communications, Research, etc.) in support of their functional area deliverables.
• Attend scientific conferences to enhance therapeutic knowledge and to contribute to execution of Medical Affairs conference deliverables.
• Per business needs, support pre-launch preparations for potential new molecules and/or label expansions
• Develops product and disease state expertise, keeps abreast of the changing pharmaceutical/biotech environment, maintains awareness of best practices in industry-based medical information practice and maintains a desire for continuous learning.
• Provides mentoring to mangers and senior managers within medical information department.
• Other duties and responsibilities as assigned.

SUPERVISORY RESPONSIBILITIES:
• No direct people-management responsibilities at this time. May indirectly supervise employee(s) and/ or vendors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
• Doctorate level degree (PharmD, MD, PhD) with at least five years of related experience; or,
• Master's level degree in related discipline and nine years of related experience; or,
• Equivalent combination of education and experience.

Experience:
• Oncology experience highly preferred.
• Pharmaceutical/biotech medical information experience.

Knowledge/Skills:
• Understanding of the pharmaceutical/biotech business and related regulations, guidelines, standards and practices and an appreciation of the impact the medical information role on business outcomes.
• Demonstrated ability to lead initiatives, manage projects and work cross-functionally with a highly ethical/compliant/results driven/customer service orientation.
• Self-motivated, organized, problem-solving, solution-oriented, collaborative team player.
• Able to act independently and assume responsibility for multiple initiatives in a fast-faced environment yet remain flexible in response to changing needs and competing demands.
• Strong skills with regard to literature searching, interpretation and verbal/written communication of complex medical, pharmacological, and scientific data to a variety of audiences.
• Close attention to detail while remaining aware of the "big picture".
• Proficient in MS office applications.

WORKING CONDITIONS:
• Works in a fast-paced/small-team environment that is growing and evolving and which requires regular reprioritization of projects while adhering to timelines and achievement of deliverables.
• Works in a role that has implications for patient-care which requires an exercise in judgment within broadly defined practices and policies.
• Up to 15% of travel is required.

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.