Lilly Senior Director GPS Medical Oncology in Windlesham, United Kingdom
Type of Employment:
Full-Time Employment - FTE
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.
The Senior Director Global Patient Safety Oncology is responsible for advising on the safety of Lilly products to maximize the safe use of Lilly products in the interest of patients, health care professionals, and the corporation. This role requires strong leadership and guidance for collecting, evaluating, and managing the safety information of Lilly investigational and marketed products worldwide.
- Support of Therapeutic Area Safety Activities
a. Provide GPS Medical leadership and input into all aspects of safety of assigned compounds and products including surveillance programs and risk management planning.
b. Ensure proactive safety surveillance:i. lead risk management activities for assigned products globally ii. lead and guide the surveillance activities of scientists on the team including signal detection, clarification and risk evaluation activities; provide support, training and continued improvement as appropriate iii. Manage safety signal decisions and actions to be taken, including communication to appropriate “customers” (e.g., Development and Brand team, Management, Affiliates, Regulators, COE, Discovery and Clinical Research and Business Units). iv. Liaise with GPS Medical team members and directors, and development and brand team members, as appropriate, to fulfill safety obligations; v. Escalate appropriately patient safety issues and provide critical information on those issues to GPS Medical leadership.
c. Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities.
d. Represent PV position to Global Products Labeling Committee and/or the Safety Review Committee as appropriate.
e. Build collaborative working relationships with other GPS Medical physicians and development and brand teams medical globally to ensure full cooperation and high quality medical evaluation of safety data for global regulatory purposes.i. Represent the therapeutic area and/or product on appropriate committees/product development and brand teams. ii. Provide medical support for Global Patient Safety Medical activities and reports within the department, as appropriate. iii. Provide Global Patient Safety expertise to internal customers (e.g., regulatory, discovery and clinical research, business units). iv. Provide medical input for review of Adverse Event cases.
f. Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of the regulatory, industry and scientific environments, laws, regulations and guidance.
- Training, Coaching, Mentoring
a. Provide training, coaching and mentorship to safety surveillance scientists, and other Global Patient Safety Medical physicians and clinical research scientists with respect to medical aspects of safety surveillance.
b. Provide Global Patient Safety Medical training for development and brand team physicians and clinical research scientists and other audiences (e.g. Regulatory, Medical) as appropriate.
c. Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map.
- Understanding and Support of the QPPV role
a. Understanding the roles and responsibilities of the EU Qualified Person and ensure their involvement in the pharmacovigilance system and processes.
b. Ensure support and information are provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.
• Medical Degree
• Clinical research or pharmaceutical medicine experience preferred
• Knowledge of drug development process
• Fluent in English; both written and verbal communications
• Excellent interpersonal, organizational and negotiation skills
• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Excellent teamwork skills.
• Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
Leadership skills essential
Region: Europe; Middle East; Africa
Country: United Kingdom
Req Id: 51508BR