Senior Principal Scientist, Oncology Translational Science and Clinical Biomarkers

Job Description

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.

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.
• 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.

NOTE: This role is available in Rahway, NJ; West Point, PA; Upper Gwynedd, PA; South San Francisco, CA or Boston, MA based on candidate preference.

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 Experience and Skills:

• Experience in clinical trial development and execution; clear strategic view on the translational needs in clinical studies; e xperience & 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

Preferred Experience and Skills:

• 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.

#EligibleforERP

Required Skills:
Biomarker Development, Biomarker Research, Clinical Development, Clinical Research, Diagnostics Development, Drug Development, Immuno-Oncology, Oncology, Oncology Research, Risk Mitigation, Strategy Development, Translational Medicine, Translational Research

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

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 salary range for this role is
$206,200.00 - $324,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully
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.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
01/31/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R378184