Director - Clinical Research Physician - GPS Medical

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Clinical Research Physician, GPS Medical
Purpose
The Clinical Research Physician (CRP) in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s’) life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership.
The CRP is the Lilly GPS Medical representative for both internal and external stakeholders regarding a product or developmental therapeutic agent, 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. Not all listed responsibilities will be applicable to all GPS Medical CRP roles.
1. Key GPS Medical Activities and Safety Oversight
▪ Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s):
i. In early phase development, performs and/or contributes to medical review of individual case safety reports for completeness and accuracy, providing company causality assessment and requests for follow up, if needed.
ii. Provides medical oversight of surveillance activities, safety signal decisions and risk management actions to be taken, including communication and/or escalation to appropriate internal or external stakeholders (e.g., GPS leadership, governance committees, development teams, Regulators)
iii. Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities i
v. Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data
v. Responsible for the oversight and actions related to regulatory queries on safety-related topics
▪ Acts as the GPS Medical lead at the time of acquisitions and integrations of new companies/assets, partnering with internal and external stakeholders to ensure seamless continuity of safety surveillance activities.
▪ Demonstrates advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP.
▪ Synthesizes complex data into actionable insights and translates technical issues into strategic discussions
2. Acts as the Lilly GPS Medical Representative for both internal and external stakeholders, interacting as prescribed in corporate guidelines and policies.
▪ Builds strong relationships with key stakeholders, representing and championing the role of safety in the organization (including):
i. Product Team Leaders and Business Unit Leadership
ii. Regulatory (including Device and CMC regulatory)
iii. Affiliate Medical Leadership/Clinical Research Physicians
iv. COE and Discovery and Clinical Research
v. External Opinion Leaders
▪ Reviews and comments on external regulatory policy and trends affecting Global Patient Safety.
▪ Represents GPS Medical in inspection and audit activities for assigned program(s)
▪ May serve on safety advisory hub committees and/or consultative cross-functional bodies providing input and guidance to clinical development teams on select safety topics
▪ May serve as a member of the Quality-GPS (AE/PC and Device) safety surveillance teams evaluating aggregate product complaint/adverse event data for potential manufacturing quality related safety signals
3. Product Safety Assessment
• Provide the sound and timely medical assessment decision making for the safety questions based on current medical and scientific data in collaboration with cross-functional partners for the following:
i. Product Safety Assessments (PSAs), Health Hazard Evaluations (HHEs), and other risk assessment documentation
ii. Device design, development, risk management, and periodic reporting
iii. CMC development, manufacturing changes, CMC submissions and CMC regulatory requests,
iv. Company anticounterfeiting activities, product shortage evaluations, quality triage escalation activities and regulatory reporting.
▪ Provide clinical evaluation of individual adverse events for possible manufacturing-related root cause for Lilly products
▪ Responsible for appropriate implementation of PSA/HHE process with manufacturing and/or marketing partners.
▪ Prepare medical complaints in response to signals identified during AE/PC and Device Surveillance.
▪ Review and approve/reject manufacturing investigation results in response to medical complaints, including escalation as needed for any identified manufacturing related safety issues.
▪ Proactive monitoring to evaluate for unanticipated safety impacts related to deviations addressed by HHEs
4. People Management
▪ Foster and support a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery
▪ Recruit, mentor, develop, and retain top clinical, scientific, and drug development talent, including clinical research physicians, clinical research scientists, and pharmacoepidemiologists.
▪ Assures staff comply with company policies and procedures
5. Understand and support the QPPV role
▪ Understanding the roles and responsibilities of the European Union Qualified Person (QPPV).
▪ Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.
6. Training, Coaching, Mentoring
▪ Provide training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.
▪ Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.
▪ Maintaining compliance with the Lilly Corporate Integrity Agreement.
7. A Clinical Research Physician, 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 is 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. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
▪ US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
▪ Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Physicians Licensing Information and Medical Education | MBC
▪ Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting.
Other Information/Additional Preferences:
▪ Prior experience in clinical trials preferred; academic and/or industry.
▪ Clinical development or pharmacovigilance experience preferred
▪ Knowledge of drug development process
▪ Fluent in English with highly effective written and verbal communication skills
▪ Strong clinical/diagnostic skills
▪ Excellent interpersonal, organizational and negotiation skills
▪ Ability to work on multiple projects and function effectively in a fast-paced matrixed environment
▪ Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines
▪ 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
▪ Knowledge of global pharmacovigilance guidelines, guidance, and regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above Strategic thinking
▪ Demonstrated success in impl