Johnson & Johnson Careers
Director Immunology Translational Science and Medicine
Requisition ID: 1805700134W
The Director of Immunology Translational Science and Medicine (TSM), will be part of a team of physicians and clinical scientists responsible for creating and executing early development plans for the portfolio of assets within the Immunology Therapeutic Area (ITA). Responsibilities include the design and execution of Phase 0-1-2 clinical studies to advance the ITA pipeline from pre-clinical stages to Proof-of-Concept (POC).
- Will design early phase programs and studies for Immunology 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.
- In partnership with Global Clinical Development Operations, contribute to all aspects of phase 0/1/2 study conduct of ITA 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.
- Will be responsible for the design of early and late phase clinical pharmacology (CP) programs for New Molecular Entities (NMEs), compounds in early development and devices.
- In partnership with ED and the Disease Area Stronghold (DAS) 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, contribute to the content, and assure the accuracy of the clinical study report.
- May manage TSM staff responsible for the design, study set-up, execution and analysis/reporting of phase 0 and phase 1 studies.
- Study-related responsibilities include: Ensure adherence to Good Clinical Practice (GCP), International Conference of Harmony (ICH) guidelines and Janssen standard operating procedures. 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, IND/CTAs, BLAs, SOPs, abstracts, manuscripts, and technical reports.
- Participate in the development of TSM operational templates; internal and cross-functional process improvement initiatives.
- Represent TSM on teams requiring ED and CP strategic and content support. Represent TSM at project functional stage gate reviews and governance meetings. 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.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
DAS/PAS, Clinical Pharmacology and Pharmacometrics, ED-Biomarkers, CMC, Toxicology, Clinical Development, Discovery Research, Global Regulatory Affairs, Project Management, Quantitative Sciences, Data Management, Medical Writing, GCDO, Commercial, QA/QC, Human Resources, Business Development, Therapeutic Development Project Teams, Biotech CoE and other cross-company Project Teams.
Clinical investigators, academic researchers, study coordinators, Contract Research Organizations, Regulatory Agency personnel, Consultants, Key Opinion Leaders and Corporate Partners.
- May help develop staff within the group.
- May supervise permanent and contract personnel, depending on qualifications.
- May be responsible for formal management, setting objectives, review of performance, identification of training needs, coaching and mentoring of direct reports.
- MD-PhD or MD with clinical training in an Immunology-related sub-specialty.
- Immunology basic science research experience with a record of peer reviewed publications and scientific presentations is required
- Four years of industry experience or relevant academic experience is required.
- Clinical Trial and/or Clinical Pharmacology experience is preferred.
- Fluent in written and spoken English
- Strong ability to work effectively in a large virtual organization, with multifunctional teams located globally
- Proactive mentality, and with a good sense of cultural differences
- 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
- Appropriate project management skills
- Proven ability to work in or to lead cross-functional teams and to effectively build credible relationships within and outside of the organization (including KOLs)
- Good organizational skills with the ability to prioritize assignments and to work under pressure to meet deadlines.
- An ability to handle complex projects and to overcome delays and obstacles.
- Willingness and ability to travel ~ 20%, including trans-Atlantic travel.
- Working knowledge of the use of Microsoft suite of software products including Excel and Word, and be an early adopter of new software including clinical data visualization tools.
Janssen Biologics (7266)
Clinical Research MD