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

Employer
Merck
Location
Gwynedd, PA, US
Posted
August 25 2017
Organization Type
Pharma
Sr. Principal Scientist/Director, Oncology Translational Science and Clinical Biomarkers-CLI006258

Description

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.

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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Job: Clinical Research (M.D.)

Job Title:Sr. Principal Scientist, Clinical Research

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Company Trade Name:Merck