Principal Scientist, Research Science:
Merck

RES002055-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: RES002055

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. 

  • Coordinate the development/approval of  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. 
  • Coordinate the development/approval of 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, 3) review reader rules 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. 
  • Coordinate the approval of the imaging section of clinical protocols to ensure they follow our standard language during protocol development. 
  • Provide technical support of regulatory filings that may include preparing written responses, developing and presenting in support of inspectors.
  • Coordinate the development/approval of the 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. 
  • 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. 
  • Collaborate with vendor strategy management and imaging oncology lead to support governance of iCROs
  • Work with compliance team to support audits and/or review audit findings of iCROs.

Qualifications

Education:  

  • A Bachelor's Degree with a minimum of fourteen (14) years of imaging and/or drug development experience, OR a Master's Degree with a minimum of ten (10) years of imaging and/or drug development experience.

Required: 

  • Trained and certified as a radiology technician with experience working in a hospital setting. 
  • Experience working with or for an Imaging CRO in support of late stage clinical trials.
  • Knowledge of multiple imaging modalities and their application to drug development.
  • Knowledge 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.
  • Knowledge of clinical imaging research process using imaging biomarkers for evaluation for efficacy and safety from program planning to submission. 

Preferred:

  • A minimum of five (5) years of experience supporting clinical drug development in an industry setting; oncology is strongly preferred.
  • Implement imaging protocol, QC, imaging analysis manual and recommend sites in support of clinical studies.
  • Project management skills including organizing people and activities and developing an effective strategy for plan and goal implementation.
  • 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. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Research Science Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement