Assoc Director, Medical Information - Oncology

Role Summary

Assoc Director, Medical Information - Oncology at Gilead (Foster City, CA) leads medical information activities for oncology, ensuring scientific accuracy and regulatory compliance of MI content, collaborates with cross-functional teams to address complex requests, and drives global MI initiatives to improve patient care.

Responsibilities

• Develop and maintain a deep knowledge of product, disease state and competitor landscape for assigned therapeutic area
• Serve as the Medical Reviewer for promotional and medical materials by applying deep product, disease-state, and therapeutic-area expertise to ensure scientific accuracy, clinical relevance, and compliance, while providing solutions-oriented guidance that supports strategic and timely content development
• Respond to unsolicited requests for medical and scientific information regarding Gilead products and documents in the request handling system
• Research and collaborate with cross-functional colleagues to address complex requests
• Create, update, and participate in review, quality check and approval of MI response documents
• Collaborate with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content
• Prepare and approve data on file to support response documents and complex requests
• Maintain document repository with routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials
• Understand the needs and preferences of internal and external partners and customers
• Review and provide analysis of MI databases for trends, customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
• Participate and support MI booths at scientific congresses
• Serve as liaison for department specific training for new staff members, cross-functional colleagues and vendors, as required
• Contribute to departmental strategic initiatives by supporting key activities within the TA, including product launches, labeling updates, patient engagement, etc.
• Execute and drive global MI initiatives and actions in a timely way to advance the provision of MI to improve patient care
• Identify, report and record adverse events and product complaints in a timely manner in accordance with SOP
• Serve as department SME for one or more product(s) or TA
• Build and cultivate relationships with appropriate functions

Qualifications

• Required: 10+ Years with BS/BA OR 8+ Years with MS/MA or MBA
• Preferred:
  • Excellent written, verbal and interpersonal communication skills, and the ability to work well in multidisciplinary teams, across geographies
  • Ability to create and clearly communicate scientific data for different audiences
  • Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment
  • Ability to analyze and evaluate clinical, biomedical and scientific data
  • Demonstrates Gilead’s core values and Leadership Commitments
  • Has a strong attention to detail, excellent project management and problem-solving skills
  • Previous experience with problem-solving and project management preferred
  • PharmD, PhD or MD preferred
  • Experience in MI preferred or comparable experience within a healthcare/clinical environment preferred
  • Experience in the pharmaceutical industry or a MI vendor preferred
  • Experience in conducting medical/promotional reviews preferred

Education

• PharmD, PhD or MD preferred