Senior Director, Translational Medicine - Gastroenterology

Johnson & Johnson   •  

Spring House, PA

Industry: Healthcare


5 - 7 years

Posted 27 days ago

The Senior Director of Immunology Translational Science and Medicine (TSM), will lead a team of physicians and clinical scientists responsible for creating and executing early development plans for the portfolio of assets in the Immunology TA, including the design and execution of Phase 0-1-2 clinical studies designed to advance the Immunology pipeline from pre-clinical stages to Proof-of-Concept (POC).

Responsible for the development of all employees within TM-Dev by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs. Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.


• Will be responsible for the design of early phase programs and studies for New Molecular Entities (NMEs). Will develop the strategy for the early assessment of proof of mechanism/concept/relevance for New Molecular Entities undergoing development for new indications. This includes plans for executing formulation changes and integration of devices into later development.

• Participate in Research and Early Development governance and budget management as a member of senior committees such as the Translational Leadership Team.

• Work with the Head, Immunology Development and Head, Early Development (ED), to refine the vision, mission and strategic objectives of TM. Strengthen the culture of TM and be an ambassador in and outside the ITA.

• In partnership with Global Clinical Development Operations, oversee all aspects of phase 0/1/2 study conduct of Immunology assets including: Identification of clinical sites and CROs that will participate in TSM trials. Review budgets of prospective clinical trials and ensure that trials are cost competitive. Participate in the management of staff responsible for the design, set-up, execution, analysis and reporting of these studies.

• Responsible for the design of early and late phase clinical pharmacology programs for New Molecular Entities (NMEs), compounds in early development and devices.

• In partnership with ED and the DAS/PAS teams, develop and execute experimental medicine (Phase 0) studies. Introduce new technology and processes to the ITA to improve probability of success

• Review and interpret clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies. Oversee the preparation and assure the accuracy of the clinical study report.

• Manage TSM staff responsible for the design, study set-up, execution and analysis/reporting of phase 0 and phase 1 studies (i.e. proof of principal, bioequivalence etc.) according to Good Clinical Practice (GCP), International Conference of Harmony (ICH) guidelines and standard operating procedures.

• Study-related responsibilities include: Ensure adherence to GCP and to all relevant internal and external guidance. As a qualified physician, has ultimate responsibility for the medical management and safety aspects of the design, conduct and analysis of clinical trials for which he/she is responsible.

• Prepare and/or direct the preparation and review of protocols, clinical study reports, clinical pharmacology and translational medicine sections of early development plans, IBs, INDs, BLAs, SOPs, abstracts, manuscripts, and technical reports.

• Participate in the development of TM operational templates; internal and cross-functional process improvement initiatives.

• Represent TSM on teams requiring TSM and clinical pharmacology advice & strategy. Represent TM at project functional stage gate reviews. Lead or participate in cross-functional working groups such as safety review boards

• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.

• Support business development and licensing evaluations.

• Identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies.


Education and Experience:

• MD-PhD or MD with sub-specialty clinical training in Immunology.

• Immunology basic science research experience with a record of peer reviewed publications and scientific presentations is required

• Six to eight years of industry experience or relevant academic experience is required.

• Clinical Pharmacologyexperience is preferred.

Required Technical Knowledge and Skills:

• Fluent in written and spoken English

• Good team member and interpersonal skills. The ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion.

• Good oral, written, and presentation skills

• Good sense of cultural sensitivity and diversity

• Appropriate project management skills

• Proven ability to lead cross-functional teams

• Good organizational skills with the ability prioritize assignments

• Being able to work in a cross-functional team environment

• Ability to work under pressure to meet deadlines

• An ability to handle complex projects and to overcome delays and obstacles.

• Willingness and ability to travel ~ 10%, including trans-Atlantic travel

• Working knowledge of the use of Microsoft suite of software products including Excel and Word