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Director Translational Medicine - Immunology Development
Reference Number: 2677
Location: PA
Our client is a major global pharmaceutical and biotech company committed to improving health worldwide. They have asked us to assist them in their search for a Director of Translational Medicine – Immunology Development.
The Director, Translational Medicine, Immunology Development, will be a leader in the Immunology Translational Medicine (ITM) team, responsible for the clinical and scientific aspects of primarily Phase 0-1 studies with occasional Phase 2 responsibility. In this capacity, the Director will decisively contribute to advance the Immunology pipeline from pre-clinical stages to Proof-of-Mechanism (POM) and/or Proof-of-Concept (POC). This position will play a dual role in that she/he will provide both scientific and experimental as well as clinical development expertise for immunology translational medicine projects that will advance a world-class pipeline of small molecules and biologic agents to address unmet need in immune-mediated diseases.
The Director’s contribution will include:
- Design and execute on compound-centric and disease-centric translational strategies.
- Design and execution of Phase 0-1 and occasionally Phase 2 Trials. Small and large molecules, alternative scaffolds. Early and late development (late development Phase 1 and experimental medicine). Clinical Pharmacology, FIH, POM in FIH or P1b and Clin Pharm (PK/PD, DDI, special populations, etc.).
- Contribution to innovation through participation in disease strategy team and through experimental medicine studies.
- Business Development, including due diligence activities.
- Design Translational Plans and identify appropriate FIH, POM (and POC) study designs for NME early development programs, in collaboration with Discovery Research, Systems Pharmacology & Biomarkers, CMC, Toxicology, Biotech CoE and other functions.
- Design strategies for new indication assessments of development compounds. Be an ITM ambassador within and outside of the immunology therapeutic area.
- Presentation of clinical pharmacology strategy and trial design for assigned NMEs.
- Implement approved strategies for early development of NMEs including FIH/POM/(POC) studies and for new indication assessment of compounds in development.
- Phase 0/1 (2) study responsibilities include: 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. Management of staff responsible for the design, set-up, execution, analysis and reporting of these studies. 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. Report the status of clinical trials to upper management. 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. Direct medical monitoring needs are expected to be 2-4 small studies at any given time. Ensure adherence to GCP and to all relevant internal and external guidances. Participate in the development of TM operational templates; internal and cross-functional process improvement initiatives.
- In partnership with translational science and the disease strategy teams, develop and execute experimental medicine studies.
- Introduce new technology and processes to the immunology therapeutic area to improve probability of success.
- The Director will represent ITM on teams requiring TM and clinical pharmacology advice & strategy and represent ITM at project functional stage gate reviews. Lead or participate in cross-functional working groups such as safety review boards. Identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies. Collaborate with other J&J corporate partners to optimize drug development programs. Support business development and licensing evaluations.
- 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.
- Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.
We seek candidates with the following qualifications:
- MD or MD PhD required.
- Previous basic and/or clinical research experience and minimum 3 years of industry experience.
- Phase 0/1/2 and Clinical Pharmacology experience.
- Immunology experience.
- A record of peer reviewed publication and experience in scientific presentations.
- The ability to travel 10%, including travel abroad, is required.
Do you have the skills and experience we seek and want to advance your career with a leading global healthcare organization? If so, please email your resume or CV as a Word attachment to us today. Please include your daytime contact information and we will contact you confidentially or reply to your email.
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