Senior Director, Clinical Program Lead - MD "Job Details"
NY, United States
Job Description
Position Description
Cellectis is seeking a highly motivated and experienced Senior Director, Clinical Program Lead - MD to support the development and execution of our innovative proprietary UCART allogeneic CAR T-cell therapy programs. Reporting to the Executive Vice President & Chief Medical Officer, the successful candidate will play a key role in the development of the Company’s ground-breaking gene-edited clinical stage Universal CAR T-cell product candidates (UCART).
The Senior Director, Clinical Program Lead - MD will act as the clinician to a number of cross-functional teams responsible for the design, implementation, monitoring, analysis and reporting of studies conducted within one or more programs. They will work with the CMO to design and implement the development strategy plan and supporting clinical strategies that are necessary for effective and efficient planning and execution of Cellectis’ programs. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Development and Regulatory teams to support the development of program deliverables to support the drug development plan.
Responsibilities
- Responsible for all clinical deliverables within the assigned clinical program/asset;
- Develop and execute drug development strategies across all stages of clinical development;
- Deliver effective and timely study protocols in collaboration with clinical investigators, KOLs and regulatory agencies to meet the Company’s scientific and corporate objectives;
- Contribute to the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans;
- Provide ongoing medical monitoring for clinical trials as required, including assessment of eligibility criteria, toxicity management, and drug safety surveillance, including review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information;
- Ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice;
- Coordinate the collection and analysis of clinical data for internal and external analysis and review;
- Part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections;
- Prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings;
- Develop manuscripts for publication in peer-reviewed journals;
- Serve as a scientific and clinical point of contact for assigned programs within Company’s Clinical Development teams;
- Provide scientific and clinical guidance to all clinical development, preclinical, regulatory, and project management staff;
- Remain current on the standards of practice in the relevant therapeutic areas through review of the scientific literature, relationships with KOLs and outside advisors and attendance at relevant scientific meetings in order to provide input and guidance for the strategic direction of the Company’s programs;
- Attend and participate at Investigator Meetings and engage in preparation of subject narratives, review of study reports and other documents, and preparation and/or review of periodic and interim safety reports;
- Work closely with functional groups to ensure that protocol development and implementation follow the safety monitoring plan.
Qualifications and Experience
- M.D. with minimum of 8-12 years of drug development in large pharma or in biotech required;
- Strong understanding of full lifecycle of drug development process required;
- Experience in cellular and gene therapies is strongly preferred, and a strong grasp of this field is essential;
- Proven success record in the design and conduct of clinical trials; experience designing, running and analyzing clinical studies, preferably with biologics (experience in the field of immuno-oncology);
- A proven track record of effectively applying medical expertise to make good clinical decisions;
- Board certification, or eligibility, in Oncology, Hematology, Hematology/Oncology, or related specialty is preferred;
- Demonstrated experience progressing therapeutic programs from IND-enabling studies into the clinic and in early phase clinical development, experience in biologics preferred;
- Familiarity with FDA and EMA regulations processes and guidances/guidelines; experience with global Regulatory (Health) Authorities;
- A hands-on, independent and driven individual who can take charge of the work and is willing to contribute at different levels; e.g., engage with investigators, KOLs, etc. one-on-one as well as dig into the data.
Additional Qualifications
- Experience in managing development teams and serving on or leading cross-functional teams.
- Excellent interpersonal, negotiation, problem-solving, communication, and analytical skills.
- Strong risk management, problem-solving and crisis management skills.
- Proficient in writing protocols, reports, and regulatory documents.
- Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities.
Physical and Location Requirements
- Position is based in New York, NY.
- Cellectis is a hybrid workplace with 4-days a week required onsite.
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