Calibr was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Calibr, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Scripps Research is ranked the most influential institution in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr’s drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. Calibr offers scientists from a wide range of disciplines the opportunity to apply their skillsets to creating transformative medicines. If you have a passion for making a difference, this could be your opportunity to join our transformative team.
POSITION TITLE: Director, Clinical Development
The Director of Clinical Development will be accountable for providing oversight and medical expertise for clinical trials and to ensure patient safety. S/he serves as the single point of contact for monitoring, coding of events, safety reporting and dissemination of trial safety data, and interfacing with clinical investigators on the medical management of clinical trial subjects. The Director of Clinical Development is responsible for providing safety oversight and for reviewing the protocol and information about the study investigation product as it becomes available, such as the Investigational Brochure (IB), and reported safety events including SAE narratives, SUSARs and communicating with sites if new information emerges. In consultation with the CMO, the protocol team and clinical review committees (or Data Safety Monitoring Boards), will provide safety review during the execution of the clinical trial.
RESPONSIBILITIES and DUTIES:
Details of established essential functions for this position will be addressed/discussed during the interview process.
Provides input into medical risk factors, serious adverse event reports, medical history and other important information for benefit-risk evaluation.
Leads and participates in the internal clinical review committee meetings.
Participates on the data safety review board meeting when instituted for a clinical trial.
Reviews literature as needed to respond to safety questions for those involved in the studies including but not limited to the clinical/data review boards and IRBs/IECs.
Ensures the protocol, investigator brochure and informed consent documents meet regulatory requirements.
Ensures high quality of collected safety data.
Conducts medical review and interpretation of safety and efficacy data in collaboration with other functional lines (internal or external to Calibr).
Interfaces with contract research organizations’ pharmacovigilance groups.
Provides protocol specific training to study team, investigators, members of the CRO team and others.
Authors clinical sections of regulatory documents.
Provide medical input during development and updates to the clinical development plan.
Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team).
Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy.
Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
Liaise with Key Opinion Leaders and Principal Investigators as needed.
Specialization in Oncology or related field.
5-10 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role.
Understanding of drug safety regulations and processes and clinical trial oversight.
Experience providing input into key regulatory documentation.
Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff.
Scripps is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
The safety and well-being of our candidates, our people and their families continues to be a top priority. Until restrictions change, interviews will be conducted virtually.