Senior Principal Scientist, Oncology Translational Science and Clinical Biomarkers

MSD•South San Francisco, CA

2d•Hybrid

About The Position

Senior Principal Scientist (Sr Director), Oncology Translational Science and Clinical Biomarkers: Our Company'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. Our Company's focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. This role is in translational research and biomarker development for our Company'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 role reports to the Head of Translational Oncology. The individual 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. Working with ADT’s, early-, late-stage clinical development teams, Oncology discovery & other translational groups, the BMx leads will develop program-specific clinical biomarker strategy by incorporating critical insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, Quantitative Modeling and Biostats. NOTE: This role is available in South San Francisco, CA; Boston, MA; Rahway, NJ; West Point, PA or Upper Gwynedd, PA based on candidate preference.

Requirements

PH.D., M.D. or M.D./Ph.D. with a minimum of 10 years' experience in oncology biomarker studies and translational clinical research
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
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
Track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development
Strong interpersonal skills, as well as the ability to function in a team environment
A proven track record in biomedical research
Demonstrated record of scientific scholarship and achievement

Nice To Haves

Prior drug discovery experience 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.

Responsibilities

Identify asset-specific translational deliverables & gaps.
Building testable hypothesis & forming BMx strategy: collaborate across different LFs, to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational research strategy to test the hypothesis.
Alignment, risk mitigation & strategy implementation: align with asset development team strategy. Build critical scientific insight to identify gaps and risks, pro-actively develop mitigation plans. Work with matrixed stakeholders to ensure implementation.
Collaborate with Asset Development Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team; Biostats, Molecular Assay teams, and other key LFs to author protocol-specific biomarker plans and ensure their efficient implementation.
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.
Analysis, interpretation & impact: collaborate with forementioned line functions 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.
Contribute to Health Authority engagements; Registrational Effort and Post Marketing Commitments.
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.

Benefits

Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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