Research Physician-Clinical Pathologist - Eli Lilly and Company

The LEM-CAG (Clinical Advisory Group) Research Physician will provide medical and scientific leadership to the staff of the Laboratory for Experimental Medicine (LEM) for the development, transfer, and validation of assays for the quantification of novel biomarkers (immunogenicity and related biomarkers) used to facilitate the development and regulatory approval of new molecular entities. In this role, the emphasis will be on the implementation of immunogenicity and related biomarker assays to support the clinical portfolio. The LEM-CAG Research Physician will also provide medical expertise and consultative support to Program and Product Teams, internal Lilly partners, third-party organizations, regulatory agencies and external partners on medical and scientific issues concerning immunogenicity and related novel biomarkers.

Primary Responsibilities:

Manage immunogenicity, related biomarker activities and other clinical diagnostics in compliance with Lilly policies, local and international regulations, laws, guidance (e.g. FDA, EMA, ICH, etc.), Good Clinical Practices (GCPs) and corporate integrity agreements, as applicable.

Actively engage in developing novel immunogenicity solutions compliant with regulatory expectations.
Provide technical oversight of third-party organizations throughout the transfer, validation and implementation of LEM diagnostic assays used in human clinical trials.
Participate in governance of Lilly relationship with third-party organization including management of the vendor quality system agreement, master service agreement, periodic inspections/audits and annual governance review.

Lead and collaborate with clinical teams to identify, develop and implement strategies to fully characterize, minimize and monitor the impact of immunogenicity on clinical outcome (benefit and risk) for patients treated with a Lilly biologic and to provide data analysis and interpretation relevant to these strategies.
Define regulatory-compliant clinical immunogenicity assessment strategies for drug candidates and guide implementation throughout development including managing all immunogenicity-related clinical and regulatory documentation support.

Develop and deliver immunogenicity-focused regulatory submission strategies for Lilly assets including participation in all immunogenicity-related regulatory interactions.
Coordinate consultative and collaborative activities extending to (1) Global Patient Safety (GPS) including service on key LRL safety committees, (2) Clinical Pharmacology/Exploratory Medicine, (3) ADME-Toxicology-PKPD, and (4) other functional areas dependent upon expertise.

In addition to the scientific/clinical responsibilities described above, the LEM-CAG Research Physician also advises and influences discovery/preclinical teams regarding clinically meaningful translational opportunities.

The LEM-CAG Research Physician will be expected to maintain and expand an active external focus that includes interaction with relevant regulatory agencies as well as deliver scientific presentations and publications that will demonstrate deep scientific rigor around Lilly’s approaches to immunogenicity

Contribute to Lilly’s in-licensing efforts of new molecules and the development of strategic partnerships.
Participate in continued training and educational efforts in clinical development and demand realization related to processes requiring laboratory medicine expertise (including investigator start-up meetings, IRB, research organizations, research cooperative groups, regional business unit staff, regulatory reviews, and partnership development efforts).

Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers

Actively participate in recruitment, diversity, and retention efforts

Participate in committees, initiatives and task forces as requested by local/corporate management

Model the Lilly leadership behaviors

Be an ambassador of both patients and the Lilly Brand

Minimum Requirements:

Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.

Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm

Additional Preferences:

Minimum of two years of experience or training in clinical pathology/laboratory medicine, pharmaceutical drug development, immunology/immunogenicity, or similar field is strongly preferred.

Experience in analytical methodologies and clinical diagnostics.

Ability to investigate state-of-the-art analytical technologies.

Knowledge of regulatory requirements for clinical biomarker and clinical immunogenicity assessment and method validation/performance (e.g., GLP, CAP, NCCLS).

Excellent problem-solving ability.

Proven leadership and organizational skills, including strong interpersonal skills

Excellent oral and written communication skills

Ability to influence and mentor other individuals.

Familiarity with the design and conduct of clinical trials.

Proven experience with experimental design, scientific approach to problem solving, bioanalytical method development, validation and laboratory management.

Experience working in a regulated (e.g., GLP, GCP, GMP, CAP, CLIA, etc.) environment
Clinical research or pharmaceutical medicine experience preferred

https://lilly.wd5.myworkdayjobs.com/LLY/job/US-Indianapolis-IN/Research-Physician-Clinical-Pathologist_R-19879