Principal Scientist (Director), Oncology Translational Science and Clinical Biomarkers

Job Description

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. At our Company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.

Working with ADT’s, early- & late-stage clinical development teams, the BMx leads will develop asset-specific clinical biomarker strategy by incorporating critical insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, QP2 and BARDS.  

KEY 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.

• The individual is in translational research and biomarker development for our Company's Oncology programs.

• Working with early- and/or late-stage clinical development teams, they will have the opportunity to drive translational research and clinical biomarker development for critical oncology clinical programs. 

• 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. 

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:

• PH.D. M.D or M.D./Ph.D. with a minimum of 10 years' experience in oncology biomarker studies and translational clinical research

Required:

• 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:

• 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.  

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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