Associate Scientific Director- Oncology Translational Research Leader
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Scientific Director, 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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Scientific Director’s responsibilities include but are not limited to:
- Oncology Translational Research Lead for compound specific program(s) in Prostate disease area supporting pre-clinical and clinical studies.
- Project lead for Prostate disease characterization efforts focused on targeted therapies, immuno-oncology and other key areas
- Point of contact for compound development team (CDT), clinical and diagnostic teams, collaborators, translational and discovery teams on biomarker strategy and execution
The Translational Research Lead will serve multiple roles within the Prostate Disease Area Stronghold (DAS). As a Translational Research (TR) leader for specific programs, he/she will:
- Develop and implement the translational research strategy for portfolio compounds in both early and late stages of development.
- Serve on CDT and support the strategy by providing the rationale and justification of the research goals.
- Guide Oncology Translational project planning and resource modeling and communicate with Translational Leadership, Project Management, Finance, Discovery, and the relevant CDT and Clinical leaders to implement the plans.
- In conjunction with Companion Diagnostics Lead develop the strategy, execution and oversight for compound specific Companion Diagnostics, where applicable.
- Lead multiple Prostate DAS internal and external projects including academic collaborations to address key translational goals for compound development strategy, or further understanding of disease segments, or clinico-genomic strategies while supporting long-term DAS goals.
- Guide development of new platforms and technologies that have applicability to oncology drug development within Prostate DAS indications.
- Ensure common scientific standards for translational data generated in clinical studies or collaborations.
- Interpret and present results driving compound development decisions. Results will be communicated to the leaders of the Translational Research (TR) group, senior leadership in Janssen and other relevant Johnson & Johnson business units.
- Enable delivery on goals and objectives set for the Oncology TR group and the Prostate DAS including both pre-clinical and clinical projects.
Essential functions include management of translational and biomarker strategies by:
- Planning and execution for discovery and validation of predictive, pharmacodynamic, prognostic, safety, and disease biomarkers.
- Planning and managing a Translational Research budget and resources to support biomarker discovery and validation studies as well as analysis of clinical samples.
- Establishing and maintaining collaborative relationships with internal, external academic groups and CROs to facilitate the implementation of translational strategies in clinical trials.
- Leading collaborations and projects with external key opinion leaders in the field.
- Coordinating clinical trial biomarker analyses with internal and external partners.
- Analysis of biomarker data from clinical trials and preclinical studies, interpretation and application of results to clinical development strategy
- Reporting biomarker data to the CDT and Oncology senior management.
- Delivering the biomarker sections in Clinical Protocols, Investigator Brochures, Compound Development Plans, Clinical Study Report, and Regulatory documents including but not limited to IND and NDA/ BLA supporting reports.
- Gaining internal alignment on translational research strategy, and championship of the strategy to internal and external stakeholders and regulatory agencies.
- Compliance with and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)
- The Associate Scientific Director will hold a Ph.D. or an M.D./Ph.D. in Molecular Biology or related field with at least five (5) or more years of applicable biomarker, translational research, program management, clinical trial and/or research experience of which three or more years of pharmaceutical or biotechnology industry research experience preferred
- Strong background in tumor biology, immune-oncology, project management, and laboratory management experience preferred.
- Experience with companion diagnostic or assay development preferred
- Strong publication record demonstrating relevant experience in clinical trials, translational medicine/research, early drug development, drug discovery and/or biomarkers preferred.
- Strong communication skills required.
- Strong experience in drug discovery and/or early development to represent a diverse translational research group on a compound development team (CDT) preferred
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)