Requisition ID: CLI008095
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the Spark that fuels innovation and inventiveness; this is the space where Merck has codified its Legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Clinical Pathology lead functions as the primary interface with clinical teams, Translational Biomarkers Operations, Companion Diagnostics, Translational Molecular Biomarkers, Clinical Trial teams, and clinical trial research labs for topics related to pathology in clinical trials across the oncology portfolio. The primary role is to ensure pathology endpoints are met with the highest quality and within the timelines defined. In addition, other responsibilities include:
- Working with the clinical teams and KOLs, leads the strategic development and design of pathology response assessment endpoints in neoadjuvant trials including surgical specimen requirements and interpretation parameters.
- Contributes to defining pathology requirements related to patient screening and to the standardization of pathology related protocol language in early and late stage trials; provides input to Case report form design to ensure appropriate information is captured for analysis
- Directs clinical trial research labs on the implementation of trial screening and response pathology assessments; works with the clinical team and the clinical trial research lab in development of Pathology Charters and site specimen collection requirements.
- Functions as the SME and liaison with clinical trial research labs to implement pathology assessments in trials and addresses clinical trial research lab questions that arise during study start and trial execution. Participates in the review and monitoring of pathology response assessment data from the clinical trial research lab including concordance analysis
- Works with KOL and internal key stakeholders to develop a harmonized strategy and approach for pathology assessments used in clinical trials across the portfolio. Collaborates with the Oncology Neoadjuvant Working Group and the Oncology Neoadjuvant Clinical directors on pathology eligibility and related trial pathology requirements and on shared practices.
- Leads in selection and review of proposed KOL members and clinical trial research lab pathologist requirements related to pathology assessments in trials.
- Strong regulatory support: Contributes to responses to Agency/Health Authorities related to pathologic endpoints during the protocol lifecycle, may develop Background Packages and review of CSR and submission documents
- Develop/present training slides and/or formal training modules for pathology criteria for a trial for internal/external presentations, including Investigators Meetings
- Review investigator sponsored trial proposals and provide feedback on technical approach and alignment with Areas of Interest for pathology and Medical Affairs.
- Function as SME for Translational Molecular Biomarker pathology activities
Qualifications
Education Minimum Requirement:
- MD or MD/Ph.D with specialty training in Pathology and significant experience in oncologic pathology in clinical trials (>5 years)
Required Experience and Skills:
- Pharmaceutical and/or clinical drug development experience. Minimum of (2) year’s experience supporting clinical drug development in an industry or academic setting; disease expertise in Oncology
- Excellent oral (including presentation) and written communication and computer/database management skills
- Broad knowledge of clinical pathology methodology
- Knowledge of pathology component of clinical trial design incorporating biomarkers for evaluation of efficacy and safety
- Skill in authoring trial related documents for clinical studies using pathology biomarkers for evaluation of efficacy and safety
- 20% Travel
Preferred Experience and Skills:
- Regulatory experience supporting drug filings either in an academic setting, as a pharma sponsor or pathology clinical lab
- Experience working with or for a clinical pathology lab.
- Assess the impact of pathology biomarker efforts on clinical projects (quantitative value).
- Represent pathology to broad network of internal and external stakeholders; develop and maintain therapeutic area specific external collaborative network of KOLs
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.
Job: Clinical Research (M.D.)
Other Locations: Rahway, NJ, US; Kenilworth, NJ, US
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: None
Company Trade Name: Merck
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