Associate Director, Oncology Translational Research, Hematology

Biopharma Asia; Pennsylvania; Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Johnson & Johnson's Innovative Medicine translational research group seeks an experienced clinical biomarker lead (Associate Director) to shape biomarker strategies for solid tumor programs, including multiple myeloma, across early and late development.

You will lead cross-functional teams, collaborate with internal groups and external partners, ensure regulatory and scientific rigor, and drive results that inform dose selection and response assessment in clinical trials.

Qualifications

• Ph.D. or M.D./Ph.D. in molecular biology or related field with 5–10 years biomarker/translational experience.
• Strong tumor biology background and pharmaceutical/biotech industry experience.
• Experience designing pre-clinical research and mechanism studies.
• Experience in clinical biomarker/translational research, late development preferred.
• Excellent communication and leadership for CDT governance.

Responsabilités

• Manage translational strategy and implementation for one or more pipeline assets.
• Planning and execution of discovery and validation of predictive, prognostic, safety, and disease biomarkers.
• Develop, implement and deliver on the clinical biomarker strategy for the compound, participate in the CDT and lead working groups.
• Lead and guide working groups to implement clinical biomarker and translational research strategy.
• Managing a cross-functional translational research team including junior scientists, lab scientists, computational biologists, and others.
• Analyze, interpret and present emerging clinical biomarker data.
• Regular reporting of biomarker data to the CDT and Oncology senior management.
• Responsibility for biomarker sections in Clinical protocols, Investigator Brochures, and CDP generation of Clinical Study Reports.
• Coordinating proposed analyses within clinical trials and ensuring timelines.
• Compliance with project deliverables and regulatory requirements.
• Collaborate across groups to explore novel indications and drug combinations.

Connaissances

Biomarkers

Clinical Trials Operations

Program Management

Translational Medicine

Drug Discovery Development

Interdisciplinary Work

Formation

Ph.D. or M.D./Ph.D. in molecular biology or related field

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Translational Discovery & Development Biomarkers

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

About Oncology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

The Heme Translational Research (TR) group is seeking an experienced clinical biomarker lead (Associate Director) to develop and execute key aspects of Johnson & Johnson Innovative Medicine’s translational efforts directed towards the clinical development of novel therapies across multiple areas of solid tumor focus.

The Associate Director will serve multiple roles within the Heme TR and specifically the Multiple Myeloma Disease Area Stronghold (MM DAS). As a Translational Research leader for specific programs, you will serve on Compound Development Teams (CDT) for the Oncology Translational Research group within the MM DAS. In addition, you will lead disease related internal/external projects to further scientific understanding of multiple myeloma.

You will provide scientific leadership in preclinical and clinical translational research programs within the Heme TR group and specifically multiple myeloma. You will develop and implement the clinical biomarker strategy for programs in early and late clinical development. Key goals will include determining proof of mechanism, informing and supporting dose, defining pharmacodynamic markers and biomarkers of response and resistance. You will need to develop strong collaborations with many functional groups across the Oncology Therapeutic Area (TA), including Discovery and Clinical organizations. Additionally, you will need to develop scientific collaborations external to the organization to develop novel insights from clinical samples into disease biology and segmentation.

Key responsibilities include:

Manages the translational strategy and implementation for one or more pipeline assets.

Planning and execution of discovery and validation of predictive, prognostic, safety, and disease biomarkers

Develop, implement and deliver on the clinical biomarker strategy for the compound, participate in the compound development teams and lead pertinent working groups.

Lead and guide working groups to implement clinical biomarker and translational research strategy and lead ongoing programs and projects.

Managing a cross-functional translational research team including junior scientists, lab scientists, computational biologists, and other relevant functions as needed.

Analyze, interpret and present emerging clinical biomarker data

Regular reporting of biomarker data to the CDT and Oncology senior management.

Responsibility for the biomarker sections in Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Report

Managing the outstanding or in-house coordination of proposed analysis within clinical trials.

Compliance and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)

Work closely across groups and functions to explore novel indications and new drug combinations for compounds in clinical development.

Generate pre-clinical experimental plan, oversee/supervise the studies, and integrate into clinical development plan.

Communicate project deliverables to the leaders across the Oncology Therapeutic Area (TA), and other senior governance groups when necessary.

Interact and liaise with internal experts, external experts, academic groups, and CROs to establish collaborations and projects.

Fulfill regulatory responsibilities including preparing, updating, and finalizing regulatory documents.

Qualifications - External

You are required to have a Ph.D. or an M.D./Ph.D. in molecular biology or related field with at least 5-10 years of applicable biomarker, translational research, program management, clinical trial and/or research experience, preferably in an industrial setting. Multiple myeloma experience preferred (but not required).

This person will have a strong background in tumor biology, project management, laboratory management, and five or more years of pharmaceutical or biotechnology industry research experience.

Extensive experience in designing and execution of pre-clinical research, in-vitro and in-vivo pharmacology, and mechanism of action studies is required

Experience in clinical biomarker/translational research is strongly preferred, including late development programs highly preferred

Familiarity with the techniques common to translational research including, but not limited to, flow cytometry, genomics, proteomics and importantly, data analysis.

The candidate must have strong communication skills and sufficient leadership experience in drug discovery and/or early development to represent a diverse TR group on a compound development team (CDT) and to communicate goals and deliverables to senior management and governance committees throughout J&J.

Experience in running multi-faceted projects and programs is preferred.

Excellent written and verbal communication skills

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

• AI Judgement Integration
• Biomarkers
• Clinical Trials Operations
• Controls Compliance
• Drug Discovery Development
• Industry Analysis
• Interdisciplinary Work
• Medical Compliance
• Medical Technology
• Organizational Project Management
• Program Management
• Quality Standards
• Safety-Oriented
• Scientific Research
• Tactical Planning
• Technical Credibility
• Technologically Savvy
• Translational Medicine