Requisition ID: CLI008096
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 Imaging Lead functions as the primary interface with the clinical teams and other stakeholders, including provide oversight of the Clinical Imaging Scientist (CIS) for trials assigned as the imaging lead. This includes ensuring timelines and deliverables are met and of high quality for the duration of the trial.
This position will work closely with the Head of Clinical Imaging and the CIS to harmonize support internally and externally for oncology trials across the oncology program including:
- Review/approve Imaging Review Charters drafted by imaging clinical research organization (iCRO) which describes how imaging endpoints will be obtained for oncology trial. This entails both providing guidance as well as seeking input from Merck statistics, clinical, regulatory, data management.
- Review/approve other key documents/decisions required by iCRO including 1) Imaging Acquisition Guidelines (specific imaging parameters for different modalities used in the trial), 2) CV/training records for selection of radiologists/oncologists for independent review, 3) review specific reader rules created for the radiologists/oncologist to guide their independent review and ensure it is consistent with imaging charter 4) attend and support mock reader training prior to launching independent reads and 5) review metrics of inter and intra reader variability on oncology basis during trial to ensure readers are performing accurately and consistently.
- Review/approve clinical protocols submitted during radial review as well as provide feedback to clinical team during protocol development.
- Provide expertise in support of regulatory filings that may include preparing written responses, developing and presenting in support of inspectors,
- Provide oversight to CIS and procurement when completing Imaging Specific Template to clearly define the Scope of Work requested by clinical team. Consider specific imaging needs of trial; experience of iCROs and budgets provided in order to make recommendation to clinical team on iCRO selection.
- Provide medical expertise in reviewing cases identified by clinical team or Merck stats based on discrepancy (i.e. different assessment calculated by stats team or modeling and simulation or inconsistent with the site assessment). Requires review of images, lesion calculations and thorough understanding of all imaging criteria for oncology trials (RECIST 1.0, 1.1, Cheson 2007, Wolchok Criteria, Prostate Cancer Working Group 2, RANO criteria).
- Develop/present training slides for imaging criteria and/or imaging requirements for a trial for internal Merck team and/or for Investigators at study launch.
- Apply Good Clinical Practice and ability to provide support to clinical teams on key imaging related issues such as radiation exposure and informed consent language.
- Apply understanding of regulatory requirements in order to support questions related to a filing or regulatory strategy related to imaging.
- Collaborate with vendor strategy management, CIS and imaging oncology lead to support governance of iCROs on quarterly basis.
- Work with compliance team to support audits and/or review audit findings of iCROs.
- Review investigator sponsored trial proposals and provide feedback on technical approach and alignment with Areas of Interest for imaging and Medical Affairs.
- Collaborate with other members of imaging team to apply quantitative imaging biomarker approaches to preclinical/translational research.
Education Minimum Requirement:
Required Experience and Skills:
- 2 + years' experience supporting clinical drug development in an industry or academic setting; disease expertise in oncology is strongly preferred.
- Regulatory experience supporting drug filings
- Knowledge of multiple imaging modalities and their application to drug development.
- Ability to design and implement the imaging component of clinical trials using imaging as a biomarker.
- Knowledge of imaging component of clinical trial design incorporating imaging biomarkers for evaluation of efficacy and safety.
- Skill in authoring clinical imaging operations documents for clinical studies using imaging biomarkers for evaluation of efficacy and safety.
- Skill in monitoring clinical imaging studies using imaging biomarkers for evaluation of efficacy and safety.
- Knowledge of clinical imaging research process using imaging biomarkers for evaluation for efficacy and safety form program planning to submission.
Preferred Experience and Skills:
- Experience working with or for an Imaging CRO.
- Conceive and implement imaging protocol, quality control measures, imaging analysis manual and recommend sites in support of clinical studies.
- Assess the impact of imaging biomarker efforts on clinical projects (quantitative value).
- Represent Imaging to broad network of internal and external stakeholders; develop and maintain therapeutic area specific external collaborative network and key imaging opinion leader development.
- Promote the development of a translational research culture by consulting with Imaging Leads regarding imaging technology development, deployment and application.
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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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
Nearest Major Market: Philadelphia