Senior Director, Medical Information
- Alameda, CA, USA
- Location: Alameda
- Department: Medical Affairs
- Division: Drug Development
- Position Type: Regular Full-Time
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.
The Senior Director, Medical Information will provide leadership of the Medical Information (MI) function, including management of the MI team and oversight of an outsourced MI Contact Center. This role is accountable for the strategic planning and tactical execution of MI-related deliverables in the oncology therapeutic area, including launch planning, development of scientific responses to health care professional (HCP) inquiries, and preparation of data submission packets for national guideline committees and key medical pathway organizations. The Senior Director will play a pivotal role as a member of the greater Medical Affairs team dedicated to scientific excellence and to ensuring accurate and appropriate medical information regarding Exelixis oncology products is received by HCPs in a timely fashion.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Accountable for leadership of the MI team including routine management, training, coaching, support of professional development, and performance evaluation of team members. Encourages best practice sharing, planning, and priority alignment within the team. Enhances efficiencies and capabilities of MI team.
• Develops product, disease state, and competitive landscape expertise and aids MI team with same. Keeps abreast of the changing pharmaceutical/biotech environment, maintains awareness of best practices in industry-based MI practice.
• Accountable for the strategic planning and tactical execution of MI-related deliverables. Ensures the development/delivery of medical information on marketed and investigational products in response to unsolicited customer requests. Responsible for MI budget.
• Accountable for oversight of the outsourced MI Contact Center. Ensures appropriate provision of MI services by Contact Center as well as appropriate collection/reporting of adverse events and product quality complaints.
• Ensures the MI team contributes to the development and implementation of medical plans and aligns MI deliverables to the plans, including those designed in anticipation of launches.
• Recognized as an internal subject matter expert in the field of MI practice and responsible for the delivery of high-quality MI deliverables, including the following core deliverables:
o MI launch plans
o Standard Responses, FAQs, and Custom Responses
o Academy of Managed Care Pharmacy (AMCP) Dossier
o National guideline committee and compendia data submissions
o Key pathway data submissions
o Coordination of MI resources for medical conferences
o Analysis of MI trends and data gaps
• Participates as a strategic partner with other Medical Affairs subteams and other functions to identify opportunities and drive appropriate integration of MI staff. Represents the MI team on multiple cross-functional teams and coaches MI team members to enhance their cross-functional interactions/contributions.
• Monitors the medical environment and applies scientific expertise, integrated with regulatory and compliance knowledge, to MI strategy and deliverables.
• Ensures compliance by team members and third-party vendors by developing and/or reinforcing policies/standard operation procedures/work instructions and by reinforcing company Business Conduct Manual.
• Supports a collaborative relationship with MI Departments of partner companies.
• Other duties and responsibilities as assigned.
• Direct people-management responsibilities as well as indirect supervision of vendors
• Doctorate level degree (PharmD, MD, PhD)
• Minimum of 11 years’ experience in the pharmaceutical/biotech industry, with a minimum of 5 years of experience leading a Medical Information Team.
• Minimum 7 years in a direct people management role.
• Oncology experience
• Medical Information management experience within the pharmaceutical/biotech industry.
• Understanding of the pharmaceutical/biotech business and related regulations, guidelines, standards and practices and an appreciation of the impact the MI Department has on customers, patients, and business outcomes. Ability to apply FDA, legal, regulatory, and compliance requirements as it applies to MI deliverables.
• Demonstrated ability to think strategically, influence without authority, 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 with good time management skills.
• Ability to translate complex scientific data into impactful MI deliverables.
• Able to act independently and assume responsibility for the MI Department and 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 communication of complex medical, pharmacological, and scientific data to a variety of audiences.
• Close attention to detail while remaining aware of the “big picture”.
• Excellent written and verbal communication skills.
• Proven track record in working in a dynamic, cross-functional environment.
• Knowledge of applicable regulations regarding the dissemination of medical information and adverse event and product quality complaint reporting.
• Strong people management skills and ability to effectively lead and motivate a high performing team.
• Proficient in MS office applications.
• 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 cross-functional environment with colleagues at varying levels within the organization, including Medical Affairs, Regulatory, Legal, Compliance, Drug Safety, Quality, and Commercial.
• Works in a role that has implications for patient-care which requires an exercise in judgment within broadly defined practices and policies.
Ability to travel domestically approximately 15% of the time.
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.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.