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

Job Description

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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.

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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

Expected US salary range :

181,600.00 - $285,800.00

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.

Employee Status : Regular

Relocation : Domestic

VISA Sponsorship : No

Travel Requirements : 10%

Flexible Work Arrangements : Hybrid

Shift : 1st - Day

Job Posting End Date : 01 / 13 / 2025

• 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.

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Salary : $181,600 - $285,800