Director, Oncology Translational Science and Clinical Biomarkers

Employer
Merck
Location
Upper Gwynedd, PA, US
Posted
May 08 2018
Organization Type
Pharma
Requisition ID: CLI007365

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 position is in translational research and biomarker development for Merck’s Oncology programs. Working with early- and/or late-stage clinical development teams, he/she will have the opportunity to drive translational research and clinical biomarker development for critical oncology clinical programs.  This New Jersey or Pennsylvania-based position will be part of the Translational Oncology Development Team, reporting into the Executive Director of Oncology Clinical Biomarkers.  The position will assume a role in a dynamic, cross-functional environment as a key member in early- and/or late-stage development teams and work closely with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development.  


Key responsibilities include, but are not limited to the following:

• Hypothesis-building & strategy forming: collaborate with stakeholders in clinical development team(s), to formulate testable clinical hypothesis and develop clinical biomarker and translational research strategy to test the hypothesis.   

• Alignment, risk mitigation & strategy implementation:  align the development team strategy with broader portfolio strategy.  Build critical scientific insight to identify gaps and risks, pro-actively develop mitigation plans.  Work with matrixed stakeholders to ensure implementation.   

• Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis and interpretation.  Effectively communicate the study plan, update and output across different function areas to for optimal impact on projects.       



Specific responsibilities include, but are not limited to the following:

• Work closely with Product Development Team and/or Early Development Team stakeholders.  Set protocol-level, hypothesis-driven translational science and biomarker strategy.  

• Collaborate with clinical and companion diagnostic leads, author protocol-specific biomarker plans and ensure their efficient implementation.  Co-lead a regularly scheduled biomarker meeting for the development team (s).

• Collaborate with experimental experts, bio-informatics experts, statisticians and clinical stakeholders to build formal statistical analysis plans, analysis reports and data communication plans.  Participate in data analysis and interpretation.  

• Interface with translational and discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets.

• Incorporate cutting edge scientific and technical advances to support clinical developments.  Proactively identify and engage external KOL’s on specific hypothesis-driven collaborations to complement internal effort. 

• Drive the publication of biomarker and translational research for respective studies.


Qualifications

Education Minimum Requirement:  

  • Ph.D. M.D or M.D./Ph.D.


Required Experience and Skills**:

  • with a minimum of 12 years' experience in oncology biomarker studies and translational clinical research
  • Must have experience in clinical trial development and execution; clear strategic view on the Translational needs in clinical studies; Experience & familiarity with experimental and bioinformatic aspects of translational research and biomarker development.   
  • Strong interpersonal skills, as well as the ability to function in a team environment are essential
  • A proven track record in biomedical research is essential;
  • Demonstrated record of scientific scholarship and achievement;
  • Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology, preferably immuno-oncology
  • Possess communication and analytical skills to regularly interface with a wide variety of stakeholders within the organization, as well as with external clinicians and scientists
  • Proven track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development.

 


Preferred Experience and Skills:

  • Prior experience in drug discovery in oncology
  • Prior experience in communication with health authorities
  • Specific expertise in immunology and/or immuno-oncology
  • Experience in companion diagnostics development 
  • Project experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired.   



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.

 

Visa sponsorship is not available for this position.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Clinical Research (M.D.)
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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