Director Clinical Development
Calibr, a division of The Scripps Research Institute (Calibr) is seeking a talented, motivated candidate for Director of Clinical Development in the area of immuno-oncology.
Calibr is a not-for-profit, tax-exempt (Section 501(c)(3)) medical research center located in La Jolla, California. Calibr is focused on innovative early stage translational research in collaboration with academic partners in the areas of regenerative medicine, cancer biology, cardiovascular and metabolic disease, immunology and infectious disease. The organization was established to accelerate the discovery of new therapies and bridge the gap between academic research and drug development in the commercial sector. Calibr has rapidly developed a highly productive drug discovery infrastructure and robust preclinical pipeline through collaborations with foundations such as the Bill & Melinda Gates Foundation, Wellcome Trust and JDRF, government funders and biopharma partnerships. These efforts have resulted in a suite of new candidate medicines that will enter human clinical studies over the next six to 24 months.
In October 2016, Calibr became an affiliate of The Scripps Research Institute (TSRI), a world-renowned research institute making major advances in basic science and significant contributions to new medicines. By bringing together the capabilities of these two established organizations – basic research at TSRI and translational research at Calibr – a powerful new model for ‘bench-to-bedside’ biomedical research has been created. TSRI and Calibr have created a framework for seamless collaboration that allows research discoveries from TSRI to seed joint drug discovery projects with Calibr, with the goal of ensuring a sustainable pipeline of new drug candidates that will impact patients for years to come.
More recently, Calibr established a strategic research agreement with AbbVie on a novel, switchable CAR-T cell platform. This collaboration will provide Calibr with additional resources to translate this therapy to a first in human clinical trial in 2019. The Director of Clinical Development will assume direct responsibility for this trial, including study design, protocol writing, implementation, and operational management with support of the internal translational team members and leveraging external contract research organizations. Walking in the door, s/he will take leadership of the CAR-T cell clinical program at Calibr. There is tremendous opportunity to impact the future of developing innovative medicines and no better time in the organization’s history to be joining than now.
Essential Duties and Responsibilities:
- Management and oversight of the clinical aspects of Calibr’s CAR-T cell and immuno-oncology assets.
- Lead in study design, protocol writing, analyses and interpretation of clinical trial data and the reporting of clinical trial results.
- Responsible for review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information.
- Provide leadership on the clinical development strategy for Calibr’s preclinical programs in immuno-oncology. Near term objectives include initiation of a first in human clinical trial on a novel CAR-T cell program in 2019.
- Manage regulatory strategies and interactions with global regulatory authorities.
- Work closely with Calibr translational sciences and clinical teams to manage ongoing activities and make recommendations to management and the advisory board.
- Build and maintain solid working relationships with key opinion leaders and academic thought leaders, lead clinical investigators, cooperative groups, and other clinical stakeholders.
- Experience managing drug discovery or translational medicine activities.
- Proven track record of success across all phases of drug development, proven success record in clinical trial design and protocol writing required. Filing experience highly advantageous.
- Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group.
- Experience in immuno-oncology required, direct experience in cellular therapies, especially CAR-T cell therapy strongly preferred and a strong grasp of this field is essential.
- Knowledge of FDA regulations and guidelines related to IND and first in human trials is essential.
- Experience in interactions with FDA personnel required including historic success achieving successful outcomes with global regulatory bodies is required, experience working with both CDER and CBER is strongly preferred.
- Extensive experience in early stage development, first in human clinical trial design, and translational medicine as it relates to oncology is essential.
- PhD, MD required, MD/PhD preferred.
- 8+ years’ experience in clinical development.
- For the best fit, must have the ability and strong desire to “make things happen”. Must have a results-oriented work ethic and a positive, can-do attitude.
- Effective leadership, people management, communication skills and a team-oriented style area essential.
- Must be willing and able to be hands-on.
- Flexible, creative, and resourceful style and attitude is required. Must be open to change and the unknown with ability to shift gears quickly.
- Extremely bright and strategic thinker with a high degree of self-initiative.
- Trustworthy with highest integrity, committed to ethics and scientific standards.