Sr. Principal Scientist/Director, Oncology Translational Science and Clinical Biomarkers

Employer
Merck
Location
Upper Gwynedd, PA, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: CLI006258

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’s Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At Merck, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. 


The Director will leadthe design and execution of cutting-edge translational science and clinicalbiomarker research across Merck Oncology programs. This individual willcoordinate the activities of a team of translational science and clinicalbiomarker leads supporting both early- and late-stage clinical developmentteams. The Director will have the opportunity to guide the development oftranslational research and biomarker plans across the entire portfolio ofearly- and late-stage oncology clinical programs.

 

Reporting into the Headof Translational Oncology, this individual will assume a role in a dynamic,cross-functional environment as the leader of an effort that represents the keyinterface between early-and late-stage development teams and functional areaswith expertise in various scientific and operational aspects of translationalresearch and biomarker development. The Director will guide the development andoversee the activities of individual team biomarker and translational scienceleads.  This guidance will ensure that translational science-relatedcommunication is optimized between development teams and the widerorganization, emerging translational data from individual clinical programs areinterpreted and communicated for maximal impact, and team-level clinicalstrategy and clinical study design are guided by emerging cross-programmatictranslational data. 

 

Responsibilities willinclude, but are not limited to the following:

  • Strategic and tacticaloversight of all product- and protocol-level translational research andexploratory biomarker plans
  • Participate in theanalysis of a wealth of translational data from Merck-sponsored clinicalstudies, and help to guide the creation translational research partnershipswith leading academic investigators and nonprofits
  • Will be part of a teamof cross-functional leaders that guide Translational Oncology strategy acrossMerck’s oncology portfolio.  These efforts are expected to transform ourunderstanding of the mechanisms of response and resistance to cancerimmunotherapy, leading to the identification of new drug targets and biomarkers
  • Oversee the activitiesof a set of translational science and clinical biomarker leads across early-and late-stage oncology clinical development programs
  • This position will haveat least two direct reports as well as a number of indirect/matrixed reports
  • Guide team’sprofessional development, set goals and metrics to maximize their impact asmembers of early- and late-stage development teams.  
  • Ensure that team-levelbiomarker and translational research strategies and protocol-level biomarkerplans are fully articulated and aligned with broader translational research andexploratory biomarker work across the portfolio.  
  • While working withcolleagues across multiple functional areas, ensures that translational scienceand biomarker efforts are optimally integrated into the broader organizationalstructure.  
  • Addresses operationalissues associated with biomarker efforts, optimizing the informatics toolsavailable to biomarker leads to allow them to leverage our growing internaldatasets, building formal communication channels to ensure effectivecommunication of emerging preclinical, translational and clinical observations,and ensuring cross-functional alignment with clinical, diagnostics andtranslational research leadership.  

In conjunction withcolleagues in the translational research organization, supports the developmentof a portfolio of partnered translational research that compliments thebiomarker efforts in our sponsored studies.  Interface and collaborateexternally with biologists, geneticists, physicians, pathologists, andbioinformatics experts to develop a scientifically and strategically robustportfolio of research that will answer critical questions about mechanisms ofimmunotherapy response and resistance.  

 

Specificresponsibilities include, but are not limited to the following:

  • Provide high-level oversight ofthe entire portfolio of translational research and early biomarker effortsin Merck-sponsored oncology studies.  Ensure that team-leveltranslational science and biomarker strategy is robust and addressescritical indication-specific, drug-specific and cross-programmaticscientific questions. Co-lead a forum for formal review of allprotocol-level biomarker plans.
  • Oversee the professionaldevelopment and ensure the success of individual translational science andbiomarker leads.  Develop organizational resources and structure tosupport their training and continuing education. Provide guidelines andmetrics for success. 
  • Collaborate with diagnosticdevelopment leadership, ensure that translational research and clinicalbiomarker development efforts are harmonized with program-specificdiagnostic needs. 
  • Ensure that operationalresources are optimally aligned to support the science.  Interactwith clinical, laboratory and genomics operational leads to optimizeprocesses, and procedures.
  • Oversee biomarker leads as theyprepare and execute data analysis plans, in conjunction with computationalbiology, informatics and other data analysis experts.  (Ensure thatbiomarker leads can interpret and communicate scientific and strategicinsights from emerging data for maximal impact within their individualteams.)
  • Participate in broader strategysetting and administrative efforts as a member of the TranslationalOncology Leadership Forum.   
  • Provide input to computationalbiology and informatics colleagues as they  develop custom datavisualization tools.  
  • Drive reverse translation ofclinical findings. Interface with translational and discovery laboratoriesto drive implementation of preclinical/translational projects based onemerging clinical/translational datasets.
  • Build and support externalpartnerships.  Guide individual biomarker leads to interact withexternal investigators around development of new translational researchproposals. 
  • Qualifications

    Education: 

  • M.D or M.D/Ph.D or Ph.D
  • Required: 

  • A minimum of 10 years' experience in biomarker and diagnostics development and/or translational and early stage clinical research
  • Demonstrate a broad understanding of the end-to-end drug and diagnostic development process
  • Proven leadership ability, and specific expertise in oncology and/or immunology
  • Must have experience in clinical trial development and execution
  • Demonstrated record of scientific scholarship and achievement
  • A proven track record in clinical medicine and background in biomedical research
  • Strong interpersonal skills, as well as the ability to function in a team environment
  • Possess a broad range ofknowledge and expertise that spans preclinical and translational research inoncology and/or immunology, early biomarker development, clinical applicationof biomarkers and diagnostics, and clinical trials
  • Possess the communicationskills to regularly interface with a wide variety of stakeholders within theorganization, as well as with external clinicians and scientists
  • A proven track record ofleadership, mentorship and management
  • Preferred Experience:

  • Board Certified or Eligible in Oncology
  • Prior experience in oncology and/or immuno-oncology biomarker development, with expertise in preclinical, translational and/or early-stage clinical research in oncology
  • Demonstrated leadership, management and mentorship ability
  • Specific expertise in immunology and/or immuno-oncology
  • Direct experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired.   In particular, must have the ability to apply a strategic mindset to the generation and interpretation of exploratory biomarker data, with an understanding of how such data can be used to accelerate preclinical and clinical drug development
  • Proven mastery of both technical and bioinformatic aspects of translational research and biomarker development.  Facility with the generation and interpretation of high-dimensionality datasets
  • Experience leading cross-functional, highly matrixed collaborative groups
  • Excellent communication skills that can cross technical areas
  • 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 an accommodation for the application process please email us at staffingaadar@merck.com.

      

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    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.

     

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    Job: Clinical Research (M.D.)
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    Employee Status: Regular
    Travel: Yes, 25 % of the Time
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    Company Trade Name: Merck

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