Associate Director, Translational Medicine, Nonclinical Development

Jobtailor

Cambridge (MA)

On-site

USD 140,000 - 190,000

Full time

7 days ago

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Job summary

Jobtailor is seeking an experienced biomarker leader to develop translational strategies for clinical development, regulatory paths, and product commercialization in collaboration with cross‑functional teams.

You will partner with Research to identify biomarker endpoints in preclinical studies, validate methods for clinical use, and support biomarker deployment in trials across US and international sites. Strong immunology background is valued.

Qualifications

Ph.D. in Biology or related field with at least 4 years of industry experience.
Experience with biomarker endpoints for early-stage clinical development in CNS, ophthalmic and inflammatory diseases is desired.
Background in immunology highly desired.

Responsibilities

Develop translational biomarker strategies designed to support clinical development plans, the regulatory path, and product commercialization.
Partner with Research to discover and characterize novel biomarker endpoints in preclinical studies.
Develop biomarker methods and analytically validate biomarkers for clinical use.
Support the implementation of clinical biomarkers in clinical trials.
Partner with Biostats and Modeling and Simulations to ensure biomarker-driven decision-making across all phases of drug development.
Partner with Clinical Development, TMND, and other cross-functional teams to report biomarker results and drive interpretation and next steps.
Oversee CRO vendor/partners ensuring that they optimally execute clinical and preclinical biomarker projects in the US, Europe and other key geographic regions of interest.
Provide support for the Business Development organizations as needed on diligence efforts.

Skills

Biomarker strategy development

Analytical validation

Biomarker endpoint characterization

Clinical development planning

Data interpretation

Collaboration

Communication

Project management

Immunology background

Education

Ph.D. in Biology

Tools

Biostatistics

Modeling and simulations

CRO management

Job description

Develop translational biomarker strategies designed to support clinical development plans, the regulatory path, and product commercialization
Partner with Research to discover and characterize novel biomarker endpoints in preclinical studies
Develop biomarker methods and analytically validate biomarkers for clinical use
Support the implementation of clinical biomarkers in clinical trials
Partner with Biostats and Modeling and Simulations to ensure biomarker-driven decision-making across all phases of drug development
Partner with Clinical Development, TMND, and other cross‑functional teams to report biomarker results and drive interpretation and next steps
Oversee CRO vendor/partners ensuring that they optimally execute clinical and preclinical biomarker projects in the US, Europe and other key geographic regions of interest
Provide support for the Business Development organizations as needed on diligence efforts

Requirements

Ph.D. in Biology or related discipline with at least 4 years of industry experience
Specific experience with biomarker endpoints for early-stage clinical development in CNS, ophthalmic and inflammatory diseases is desired
Background in immunology highly desired

Core Competencies

Demonstrates expertise in developing and validating biomarker strategies for clinical development, with a strong focus on early-stage clinical trials in CNS, ophthalmic, and inflammatory diseases. Proven ability to collaborate with cross‑functional teams and oversee vendor partnerships to ensure successful biomarker implementation.

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