Eli Lilly and Company (R-19877)
Principal Research Scientist—LEM Clinical Scientist

INDIANAPOLIS, INDIANA (USA).

Overview:

The LEM-Clinical Advisory Group Clinical Scientist will provide scientific and technical leadership to the staff of the Laboratory for Experimental Medicine (LEM). We support the development, transfer, and validation of assays for the quantification of novel 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 Clinical Scientist will also provide scientific 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.

Basic Requirements:

• PhD, DVM, PharmD, or MD degree in health, medical or scientific area and a minimum of 3-5 years of clinical or pharmaceutical experience that includes 1+ years of clinical development training and experience or training in clinical pathology/laboratory medicine, immunology/immunogenicity, or similar field.

• Professional certification from the American Board of Clinical Chemistry (ABCC) or other Certification Board for Laboratory Directors of High Complexity Testing as outlined on CMS.gov (Certification Boards for Laboratory Directors of High Complexity Testing | CMS).
• Experience in analytical methodologies and clinical diagnostics
• Ability to investigate innovative analytical technologies.
• Knowledge of regulatory requirements for clinical biomarker and clinical immunogenicity assessment and method validation/performance (e.g., GLP, CAP, NCCLS).
• Proven leadership and organizational skills, including positive relationship building skills
• 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 environment
• Formal medical/clinical training or experience in pathology and laboratory medicine preferred.

Eli Lilly and Company (R-19879)
Research Physician-Clinical Pathologist

INDIANAPOLIS, INDIANA (USA).

Overview:

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.

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.

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

2 Staff Pathologist Positions

TUCSON, ARIZONA (USA). You will provide pathology support to internal groups, business units and functional areas. Makes medical/pathology related decisions and recommendations at the technical and tactical level in support of the related business unit objectives. Applies pathology concepts that contribute to development of company concepts and principles to achieve objectives in creative and effective ways on both new and existing products. Supports various ongoing assay and automated platform development projects across the company involving technologies such as immunohistochemistry (IHC) and in situ hybridization (ISH). May serve as the medical representative on project core teams and contribute to pathology related aspects of specific development projects. Monitors work to ensure quality, and continuously promote quality first time.

Responsibilities:
  •   Provides pathology and slide reading support to R&D Life Sciences, Tissue Bank, Manufacturing, Customer Support, Safety Board Meetings, and MI as
    directed.
  •   Provides pathology and slide reading support for FDA submissions, clinical trials, and Pharma clients.
  •   Supports research and development activities for primary antibodies, detection systems, probes and special stains.
  •   Makes suggestions to improve work processes. Gives advice on future pathology and medical needs.
  •   May serve as the medical representative on project core teams and contribute to pathology related aspects of specific development projects.
  •   May read clinical trial live patient slide samples for CAP/CLIA lab.
  •   Miscellaneous duties as assigned.

Formal Training/Education:
  •   M.D. - US M.D. Pathologist with Board Certification in Anatomic Pathology required
  •   Active State License required

Experience:
  •   Residency trained (Fellowship trained preferred), with 1 year of experience in clinical practice or industry.
  •   Experience in immunohistochemistry, cytology, molecular and genetics

Knowledge, Skill, or Ability:
  •   Knowledge of basic Anatomic Pathology.
  •   Demonstrated record of accomplishments, e.g., pathology related posters, abstracts, publications, concentrated area of interest/medical directorship.
  •   Skill in utilizing customary computer programs (word processing, spreadsheet, email, etc.).
  •   Skill and ability in communicating

Apply Here:
  •   https://roche.wd3.myworkdayjobs.com/roche-ext/job/Tucson/Staff-Pathologist-I_202108-123446

[26 August 2021, #11296]

Genitourinary Pathologist

SPRING HOUSE, PENNSYLVANIA (USA).

Job Description:
Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Genitourinary Pathologist, in the Oncology Therapeutic Area located in Spring House, PA.

As an Associate Scientific Director (Genitourinary Pathologist), you will act as the pathology subject matter expert in Oncology Translational Research responsible for analytical validation of immunohistochemistry assays developed by the Molecular Pathology Laboratory and provide pathology-related consultation services across the Janssen Oncology portfolio.

Responsibilities Include:
  •   Scientific management of the design, execution and analytical validation plan of immunohistochemistry assays for the evaluation of predictive and
    pharmacodynamic biomarkers in human tissues.
  •   Approve validation reports and technical reports for molecular pathology assays. Contribute to relevant regulatory documents when required.
  •   Approve assay transfer quality for assays transferred to external contract research laboratories and companion diagnostic partners in support of clinical
    development and companion diagnostic development.
  •   Perform technical audits of contract laboratories, including companion diagnostic site laboratories, and report findings in the form of written reports.
  •   Provide scientific direction and expertise in the area of pathology for both non-clinical and clinical study experiments, including writing relevant sections of
    clinical trial protocols.
  •   Communicate pathology results in the form of written and oral reports and disseminate regular written project updates to line management and relevant
    compound development team members.
  •   Evaluate, interpret and report pathology based clinical study conclusions to Translational Research representatives, to clinical development teams and to
    physicians participating in clinical trials as appropriate.
  •   Maintain familiarity with CAP and CLIA regulations
  •   Maintain familiarity with relevant regulatory requirements surrounding companion diagnostic development.

Qualifications:
  •   M.D. or D.O. degree with board certification in Anatomic Pathology is required.
  •   Extensive experience and/or subspecialty training in Genitourinary pathology is preferred.
  •   Oncology and immunohistochemistry assay validation experience is preferred.
  •   Experience in digital image analysis is desired.

Apply here: https://jobs.jnj.com/jobs/2105948348W?lang=en-us&previousLocale=en-US

[23 August 2021, #11272]