Senior Principal Scientist, Oncology Translational Science and Clinical Biomarkers

Job Description

Senior Principal Scientist (Sr Director) Oncology Translational Science and Clinical Biomarkers:

Our Companys 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 Companys 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 Companys 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 ADTs 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 KOLs 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; 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

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.

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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 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

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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