Johnson & Johnson Careers
Translational Medicine DAS/PAS Leader
Requisition ID: 4418180618
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Translational Medicine DAS/PAS Leader to be located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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.
Essential responsibilities include:
- Will be responsible for the design of early and late phase clinical pharmacology programs for New Molecular Entities (NMEs), compounds in early development and devices. Develop strategy for the early assessment of proof of mechanism/concept/relevance for New Molecular Entities undergoing development for new indications.
- 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.
- Lead the DAS/PAS Translational Medicine Clinical Team (TM-CT), cross-functional team in charge of the operationalization of all clinical studies in TM. Oversee all aspects of phase 0/1/2 study conduct including: Identification of clinical sites and CROs that will participate in TM trials. Review budgets of prospective clinical trials and ensure that trials are cost competitive. Participation in and management of staff responsible for the design, set-up, execution, analysis and reporting of these studies.
- In partnership with ED and the DAS teams, develop and execute experimental medicine 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.
- Devise strategies for Early Clinical Development Plans, executing formulation changes and integration of devices in later development
- Manage 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.
- Phase 0/1/2 study responsibilities include: Ensure adherence to GCP and to all relevant internal and external guidances. 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 TM on teams requiring TM and clinical pharmacology advice & strategy, such as the Disease Area Stronghold (DAS) leadership teams. 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.
Qualifications for the Translational Medicine DAS/PAS Leader are:
- An MD or MD/PhD with appropriate clinical training and previous basic and/or clinical research experience is required
- Six years of industry experience or relevant academic experience is required
- Clinical Pharmacology experience is required
- Immunology experience is preferred
- Translational/Experimental Medicine experience is preferred
- A record of peer reviewed publication and experience in scientific presentations is preferred
- Proven leadership skills to oversee functional teams are required
- Working knowledge of the use of Microsoft suite of software products including Excel and Word is required
- Strong oral, written communication and presentation skills are required
- Appropriate project management skills are required
- Good organizational skills with the ability to multi-task and prioritize assignments are required
- The ability to advise, persuade and negotiate with colleagues in a supportive and encouraging manner is required
- The ability to handle complex projects and to overcome delays and obstacles is required
- Up to 25% annual travel (domestic and international) is required
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Clinical Research MD