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

Employer
Merck
Location
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 lead
the design and execution of cutting-edge translational science and clinical
biomarker research across Merck Oncology programs. This individual will
coordinate the activities of a team of translational science and clinical
biomarker leads supporting both early- and late-stage clinical development
teams. The Director will have the opportunity to guide the development of
translational research and biomarker plans across the entire portfolio of
early- and late-stage oncology clinical programs.

 

Reporting into the Head
of Translational Oncology, this individual will assume a role in a dynamic,
cross-functional environment as the leader of an effort that represents the key
interface between early-and late-stage development teams and functional areas
with expertise in various scientific and operational aspects of translational
research and biomarker development. The Director will guide the development and
oversee the activities of individual team biomarker and translational science
leads.  This guidance will ensure that translational science-related
communication is optimized between development teams and the wider
organization, emerging translational data from individual clinical programs are
interpreted and communicated for maximal impact, and team-level clinical
strategy and clinical study design are guided by emerging cross-programmatic
translational data. 

 

Responsibilities will
include, but are not limited to the following:

  • Strategic and tactical
    oversight of all product- and protocol-level translational research and
    exploratory biomarker plans
  • Participate in the
    analysis of a wealth of translational data from Merck-sponsored clinical
    studies, and help to guide the creation translational research partnerships
    with leading academic investigators and nonprofits
  • Will be part of a team
    of cross-functional leaders that guide Translational Oncology strategy across
    Merck’s oncology portfolio.  These efforts are expected to transform our
    understanding of the mechanisms of response and resistance to cancer
    immunotherapy, leading to the identification of new drug targets and biomarkers
  • Oversee the activities
    of a set of translational science and clinical biomarker leads across early-
    and late-stage oncology clinical development programs
  • This position will have
    at least two direct reports as well as a number of indirect/matrixed reports
  • Guide team’s
    professional development, set goals and metrics to maximize their impact as
    members of early- and late-stage development teams.  
  • Ensure that team-level
    biomarker and translational research strategies and protocol-level biomarker
    plans are fully articulated and aligned with broader translational research and
    exploratory biomarker work across the portfolio.  
  • While working with
    colleagues across multiple functional areas, ensures that translational science
    and biomarker efforts are optimally integrated into the broader organizational
    structure.  
  • Addresses operational
    issues associated with biomarker efforts, optimizing the informatics tools
    available to biomarker leads to allow them to leverage our growing internal
    datasets, building formal communication channels to ensure effective
    communication of emerging preclinical, translational and clinical observations,
    and ensuring cross-functional alignment with clinical, diagnostics and
    translational research leadership.  

In conjunction with
colleagues in the translational research organization, supports the development
of a portfolio of partnered translational research that compliments the
biomarker efforts in our sponsored studies.  Interface and collaborate
externally with biologists, geneticists, physicians, pathologists, and
bioinformatics experts to develop a scientifically and strategically robust
portfolio of research that will answer critical questions about mechanisms of
immunotherapy response and resistance.  

 

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




  • Provide high-level oversight of
    the entire portfolio of translational research and early biomarker efforts
    in Merck-sponsored oncology studies.  Ensure that team-level
    translational science and biomarker strategy is robust and addresses
    critical indication-specific, drug-specific and cross-programmatic
    scientific questions. Co-lead a forum for formal review of all
    protocol-level biomarker plans.

  • Oversee the professional
    development and ensure the success of individual translational science and
    biomarker leads.  Develop organizational resources and structure to
    support their training and continuing education. Provide guidelines and
    metrics for success. 

  • Collaborate with diagnostic
    development leadership, ensure that translational research and clinical
    biomarker development efforts are harmonized with program-specific
    diagnostic needs. 

  • Ensure that operational
    resources are optimally aligned to support the science.  Interact
    with clinical, laboratory and genomics operational leads to optimize
    processes, and procedures.

  • Oversee biomarker leads as they
    prepare and execute data analysis plans, in conjunction with computational
    biology, informatics and other data analysis experts.  (Ensure that
    biomarker leads can interpret and communicate scientific and strategic
    insights from emerging data for maximal impact within their individual
    teams.)

  • Participate in broader strategy
    setting and administrative efforts as a member of the Translational
    Oncology Leadership Forum.   

  • Provide input to computational
    biology and informatics colleagues as they  develop custom data
    visualization tools.  

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

  • Build and support external
    partnerships.  Guide individual biomarker leads to interact with
    external investigators around development of new translational research
    proposals. 

  • 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 of
    knowledge and expertise that spans preclinical and translational research in
    oncology and/or immunology, early biomarker development, clinical application
    of biomarkers and diagnostics, and clinical trials
  • Possess the communication
    skills to regularly interface with a wide variety of stakeholders within the
    organization, as well as with external clinicians and scientists
  • A proven track record of
    leadership, 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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