Senior Director, Clinical Program Lead

3 weeks ago

Ny, United States Cellectis Full time

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.

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
* Limited travel

  • Executive Director, Clinical Program Lead

    3 weeks ago

    Ny, United States Cellectis Full time

    Position Summary Cellectis is seeking an exceptional Executive Director, Clinical Program Lead - MD to join its Clinical Science group within Clinical Development Organization. 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...

  • Senior Medical Director, Clinical Research

    1 month ago

    New York, NY, United States Axsome Therapeutics Full time

    Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. Axsome Therapeutics is seeking a Senior Medical Director, Clinical Development. The Medical Director will independently provide oversight of Medical Monitoring for clinical trials of Axsome products...

  • Nurse Director Quality Risk Management

    2 weeks ago

    Brooklyn, NY, United States Sunrise Senior Living Full time

    MAKE A DIFFERENCE EVERY DAY IN A UNIQUELY SUPPORTIVE COMMUNITY AND IGNITE YOUR FULL POTENTIAL.   Now offering DAILY PAY for the financial flexibility you need.   We champion quality of life for all seniors - and quality careers for our team members.   A career at Sunrise Senior Living means something. It means you know your work will have a...

  • VP, Senior Regional Medical Director

    20 hours ago

    Poughkeepsie, NY, United States Pediatric Associates Full time

    VP, Senior Regional Medical Director Featured Job Location Poughkeepsie, NY Facility Childrens Medical Group Poughkeepsie Schedule - Shift - Hours Full Time - Days Pediatric Associates is the largest outpatient pediatric group in the nation! The Pediatric Associates Family of Companies is a growing team of Pediatricians and Pediatric Care Teammates...

  • VP, Senior Regional Medical Director

    20 hours ago

    Poughkeepsie, NY, United States Pediatric Associates Full time

    VP, Senior Regional Medical Director Featured Job Location Poughkeepsie, NY Facility Childrens Medical Group Poughkeepsie Schedule - Shift - Hours Full Time - Days Pediatric Associates is the largest outpatient pediatric group in the nation! The Pediatric Associates Family of Companies is a growing team of Pediatricians and Pediatric Care Teammates who...

  • Director of Quality and Medical Staff

    19 hours ago

    New York, NY, United States American Society of Clinical Oncology (ASCO) Full time

    Division Director, Hematology and Medical Oncology The Laura and Isaac Perlmutter Cancer Center at NYU Langone Health is seeking applications from qualified individuals for the position of Division Director, Hematology and Medical Oncology, Perlmutter Cancer Center. The successful applicant should have substantial experience in in leadership and be able to...

  • Program Director

    20 hours ago

    Smithtown, NY, United States Catholic Health Full time

    Overview: Program Director of Medical Hospitalists Catholic Health Catholic Health is seeking a Director, Medical Hospitalists to ensure that the patients of St. Catherine of Siena Hospital receive the highest level of hospital care in the in-patient setting. Join our growing physician network of more than 2,900 physicians in Suffolk, Nassau and Queens...

  • Reintegration Program Director

    3 weeks ago

    Schenectady, NY, United States New Choices Recovery Center Full time

    NEW CHOICES RECOVERY CENTER POSITION DESCRIPTION REINTEGRATION PROGRAM DIRECTOR Position Summary: The Program Director is responsible for the safety and maintenance of the therapeutic environment of the Reintegration residence. The Program Director provides regular supervision to the Clinical Supervisor and Residential staff. It is the responsibility of...

  • Director of Life Enrichment

    20 hours ago

    Commack, NY, United States Artis Senior Living Full time

    *Starting salary is $27 - $30 / hour!*This is a full time position offering a Monday-Friday schedule, 9am - 5pm. Some evenings and weekends may be required for special events, holiday celebrations, etc. The Director of Life Enrichment will create and design the day to day activities and programming for Memory Care residents. Develop a comprehensive and...

  • Division Director, Hematology and Medical Oncology

    19 hours ago

    New York, NY, United States American Society of Clinical Oncology (ASCO) Full time

    Division Director, Hematology and Medical Oncology The Laura and Isaac Perlmutter Cancer Center at NYU Langone Health is seeking applications from qualified individuals for the position of Division Director, Hematology and Medical Oncology, Perlmutter Cancer Center. The successful applicant should have substantial experience in in leadership and be able to...

  • Community Sales Director

    2 weeks ago

    Orangeburg, NY, United States Brightview Senior Living Full time

    About UsWe are honored that Brightview Senior Living has been recognized as one of Fortune Magazine's 100 Best Companies to Work For in 2023!!  We're in the top 100 across all industries, and all companies no matter how large or small...and we're the ONLY Senior Living company on the prestigious list!  OverviewThe Community Sales Director at a Brightview...

  • Medical Director of Clinical Services

    3 weeks ago

    Brooklyn, NY, United States MedElite LLC Full time

    MedElite provides innovative solutions for skilled nursing facilities by partnering with long-term care providers and clinicians for the benefit of not only the facilities but also the specialists and most importantly, the patients. MedElite's vision is to revolutionize geriatric healthcare by combining state-of-the-art equipment and on-site expert...

  • Medical Director, Principal Investigator, Lead Physician

    20 hours ago

    Rochester, NY, United States Chapel Hill Solutions Full time

    Medical Director, Principal Investigator, Lead Physician We are currently seeking a talented and dedicated Medical Director, Principal Investigator, or Lead Physician for a great opportunity in the Rochester, NY area. The ideal candidate will possess 1 year of current experience working in a clinical research organization and have 5+ years of experience...

  • Senior Director, Digital Product Strategy

    20 hours ago

    Melville, NY, United States Catholic Health Long Island Full time

    The senior director leads the build and optimization of digital products focused on Catholic Health patients, specifically digital patient access, including online scheduling, Catholic Health MyChart / app, telehealth, and related products. The senior director is responsible for business analysis, product roadmaps, and digital performance analysis. This...

  • Medical Director, Principal Investigator, Lead Physician

    20 hours ago

    Rochester, NY, United States Chapel Hill Solutions Full time

    Medical Director, Principal Investigator, Lead Physician Rochester, NY We are currently seeking a talented and dedicated Medical Director, Principal Investigator, or Lead Physician for a great opportunity in the Rochester, NY area. The ideal candidate will possess 1 year of current experience working in a clinical research organization and have 5+ years...

  • Family Medicine

    1 month ago

    Schenectady, NY, United States Trinity Health Full time

    St. Peter's Health Partners is seeking to recruit a Family Medicine Program Director for Ellis Medicine located in Schenectady, New York. Ellis Family Medicine Residency Program is fully accredited by the Accreditation Council for Graduate Medical Education (ACGME). The training program is a single program site in a large community hospital setting and...

  • Family Medicine

    4 days ago

    Schenectady, NY, United States Trinity Health Full time

    St. Peter's Health Partners is seeking to recruit a Family Medicine Program Director for Ellis Medicine located in Schenectady, New York. Ellis Family Medicine Residency Program is fully accredited by the Accreditation Council for Graduate Medical Education (ACGME). The training program is a single program site in a large community hospital setting and...

  • Clinical Director

    19 hours ago

    Smithtown, NY, United States Templatedata.net Full time

    Position Summary: Act as part of the medical services team providing prenatal and reproductive health care according to PPHP protocol and operational process as directed by the Chief Medical Officer and/or Associate Medical Director. In addition, serves as the Clinical Director for the affiliate’s Gender Affirming Care (GAC) Program and the coordination...

  • Program Director, AGACNP-CRNA, DNP

    19 hours ago

    Hempstead, NY, United States Hofstra University Full time

    About Hofstra: At Hofstra University, intellectual curiosity is not just aspirational – it is central to how we engage on a daily basis. Hofstra faculty work within a diverse scholarly community committed to student success, intellectual discovery, free inquiry, inclusivity, and collaboration. Enrolling more than 10,000 students, Hofstra offers...

  • Program Director

    20 hours ago

    Bay Shore, NY, United States Northwell Health Physician Partners Full time

    Northwell Health – South Shore University Hospital, Amityville, NY Northwell Health’s Department of OB/GYN is seeking a Residency Program Director to help lead South Shore University Hospital’s training program located in Bay Shore, New York . The ideal candidate will provide oversight of the program to ensure regulatory compliance with the...