Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research - MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Director, Translational Medicine Clinical Lead, Translational Science & Medicine to be in Spring House, PA, La Jolla, CA or Cambridge, MA.

The Director, Translational Medicine (TM), will be a program and experimental medicine leader in the Immunology Translational Science and Medicine (TSM) function. In this position, the Director, TM, will decisively contribute to accelerating the Immunology pipeline from portfolio entry to Proof-of-Concept (PoC).

The Director, TM, will function as a clinical lead/study responsible physician on early development programs and trials. They will contribute to creating translational plans for programs that are aligned with overall TA strategy and with relevant disease area and/or pathway strategies. They will be empowered to lead a cross-functional clinical trial team to deliver on the trial's major execution milestones within governance-approved timeline and budget commitments. This responsibility extends end to end for clinical trials: from initial protocol design to continued monitoring and problem solving on trial execution to the analysis, interpretation, and communication of study results. This role will partner with Translational Sciences, and deep engagement with investigators and external experts is expected. In this leadership role, they will be supported by the senior leaders within the Translational Science and Medicine function, including the relevant disease area leaders (both in clinical development and biomarker science) and a clinical study responsible scientist. The span of studies in scope are phase 1 (including focused experimental medicine studies) through Proof of Concept.

Within TM, the Director will be part of a Translational Medicine Program Lead group which has primary responsibility within TSM for creating and implementing innovative translational plans for portfolio assets. TSM is a group within the Immunology Therapeutic Area, consisting of a Translational Medicine and Translational Science (TS). TM has combined expertise in the clinical study of immunologic disease, immunologic pathways, and in early clinical trial design and execution. TS has expertise in biomarker development, disease biology research, and in the application of immunology and data science technologies to support drug development. Organizationally, TSM serves as a pivotal bridge between Discovery Research and the later phase Clinical Development group. TSM provides the necessary scientific and clinical expertise to advance an industry-leading pipeline of novel mechanism small molecules and biologic agents to address unmet need in immune-mediated diseases. This position will play a 'dual role', contributing both scientific and clinical development expertise to TSM projects.

Responsibilities are as follows:

• Design and execute program translational strategies integrating both disease and pathway approaches.
• Design and execute early clinical trials through PoC including experimental medicine studies.
• Lead a cross-functional trial team to deliver on study milestones and commitments.
• Collaborate with translational science on the development and implementation of clinical biomarker and patient segmentation strategies.
• Support experimental medicine studies.
• Support Business Development, including due diligence activities.
• Represent TM on early development teams.
• Represent TM for project teams when presenting to portfolio, project, and governance meetings.
• Lead or participate in cross-functional working groups such as scientific and safety review boards.
• Identify and collaborate with academic translational sites to optimize the translational strategy and plans for programs.
• Prepare and/or direct the preparation and review of protocols, clinical study reports and translational medicine sections of Translational plans, IBs, INDs, abstracts, manuscripts, and technical reports.
• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.

Qualifications:

• MD or MD/PhD degree required.
• Minimum of 3 years of industry and/or translational research experience required.
• Demonstrated supervisory and/or leadership experience with clinical and/or research teams is required.
• Training in Immunology and early clinical development trials is strongly preferred.
• Experience with innovative immune cell-based or biologic therapies is preferred.
• Strong track record in publications is preferred.
• Willingness and ability to travel, including trans-Atlantic travel (up to ~10%) is required.
• Location is Spring House, PA, Cambridge, MA or La Jolla, CA.

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation -120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year

The anticipated base pay range for this position is: $199,000 - $398,000

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

#LI-Hybrid

Required Skills:
Early Phase Clinical Trials, Experimental Research, Immunology Research, Translational Medicine

Preferred Skills:
Business Savvy, Clinical Research and Regulations, Clinical Trials, Collaboration, Consulting, Data Management and Informatics, Design Mindset, Drug Discovery Development, Industry Analysis, Innovation, Market Research, Regulatory Affairs Management, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Analysis

The anticipated base pay range for this position is :
$199,000.00 - $343,850.00

Additional Description for Pay Transparency: