Director – Clinical Research Physician, GPS Medical

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organisation Overview:

Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars:

EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team – Be Creative, Be an Innovator, and most of all, Be Yourself!

Job Description Purpose:

The purpose of the Clinical Research Physician/ Scientist, GPS Medical role is to perform medical roles within the Global Patient Safety (GPS) function. These include performing as the Product or Molecule Safety Physician/Lead Physician, training /coaching /mentoring and demonstrating Global Patient Safety expertise and leadership. They will be the Eli Lilly & Co. GPS Medical representative for both internal and external customers regarding a product or molecule, interacting as prescribed in corporate guidelines, standards and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Product Lead Safety Physician / Lead Safety Physician/ Safety Scientist.

• Provide GPS Medical leadership and input into all aspects of safety of assigned compounds and products including surveillance programs and risk management planning.
• Ensure proactive safety surveillance: Lead risk management activities for assigned products globally
• 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
• 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)
• Liaise with GPS Medical team members and leadership, and development and brand team members, as appropriate, to fulfill safety obligations.
• Escalate appropriately patient safety issues and provide critical information on those issues to GPS Medical leadership.
• Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities.
• Represent PV position to Global Products Labeling Committee and/or the Safety Review Committee as appropriate.
• 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.

Represent the therapeutic area and/or product on appropriate committees/product development and brand teams. Provide medical support for Global Patient Safety Medical activities and reports within the department, as appropriate. Provide Global Patient Safety expertise to internal customers (e.g., regulatory, discovery and clinical research, business units). Provide medical input for review of adverse event cases. Lead process and provide medical input for review of suspected adverse reactions.

• Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of the regulatory industry and scientific environments, laws, regulations and guidance.

Understanding and Support of the QPPV role:

• Understanding the roles and responsibilities of the European Union Qualified Person (QPPV) and ensure their involvement in the pharmacovigilance system and processes.
• Ensure support and information are provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.

Training, Coaching, Mentoring:

• Provide training, coaching and mentorship to safety surveillance scientists, and other GPS Medical physicians and clinical research scientists with respect to medical aspects of safety surveillance.
• 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.
• Maintain compliance with Lilly and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map.
• Maintaining compliance with the Lilly Corporate Integrity Agreement. Global Patient Safety Leadership
• Provide input to Global Patient Safety Medical Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at strategic level.
• Provide ad-hoc involvement in operations, if required. Act as the Lilly GPS Medical Representative for both internal and external customers, interacting as prescribed in corporate guidelines and policies.
• Build strong relationships with key customers, representing and championing the role of safety in the organization:
• Product Team Leaders and Business Unit Leadership Regulatory Affiliate Medical Leadership/Clinical Research Physicians COE and Discovery and Clinical Research External Opinion Leaders
• Represent Global Patient Safety Medical within the company and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety.

A Clinical Research Physician/ Scientist, GPS Medical is expected to meet the criteria as outlined in the global path job criteria for the appropriate R path levels.

For each level on every global path, there are a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.

Minimum Qualification Requirements:

• Medical Doctor or Doctor of Osteopathy or scientific education
• 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.

Other Information/Additional Preferences:

• Strong clinical/diagnostic skills.
• Demonstrated success in implementing projects.
• Good communication skills, both verbal and written.
• Team player.
• Ability to effectively function in a matrix environment

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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