Medical Director, Clinical Development (Multiple Myeloma)

New York, USA

Cellectis is seeking a Physician with experience in Multiple Myeloma research and treatment to serve as Medical Director in the Clinical Development group. Reporting to the Vice President, Clinical Development, the successful candidate will play a key role at all stages of development for Company’s ground-breaking gene-editing and universal CAR T-cell technology, from the drug discovery stage through product registrations world-wide. The successful candidate will have oversight for ongoing and planned product trials within the hematology/oncology therapeutic area with a focus on multiple myeloma. The successful candidate will also serve as a liaison between Cellectis and clinical investigators/academic research personnel and will need to maintain established and productive relationships with key opinion leaders (“KOLs”).

Published on November 04, 2019

POSITION REQUIREMENTS:

  • Contributes to the design of competitive clinical strategies and deliver effective and timely study protocols in collaboration with clinical investigators, KOLs and regulatory agencies to meet the Company’s scientific and corporate objectives.
  • Provides ongoing medical monitoring for clinical trials, 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.
  • Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
  • Coordinates the collection and analysis of clinical data for internal analysis and review.
  • Contributes to the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
  • Will be 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.
  • Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
  • Develops manuscripts for publication in peer-reviewed journals.
  • Will be part of a team responsible for defending the clinical development program before regulatory authorities.
  • Serves as a scientific and clinical resource for assigned compounds/trials within Company’s Clinical Development teams, including but not limited to pharmacovigilance, biostatistics, translational research, medical, and clinical operations.
  • Provides 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.
  • Assists in the clinical evaluation of business development opportunities.

EXPERIENCE & QUALIFICATIONS:

  • M.D. degree or equivalent is required.
  • Training in hematology/oncology with expertise in multiple myeloma and a minimum of 3 years’ industry experience in clinical development is required. Experience in cellular therapies, especially CAR-T cell therapy, is strongly preferred, and a strong grasp of this field is essential.
  • Proven success record in the design and conduct of clinical trials.
  • Direct experience in early-stage development, first in human clinical trial design, and managing drug discovery or translational medicine activities as it relates to hematological malignancies.
  • Demonstrated passion for innovative translational research and development leading to the discovery and advancement of novel therapeutics.
  • Demonstrated success managing interactions with CROs, consultants and other contract organizations, especially from the context of a small group.
  • Knowledge of FDA regulations and guidelines related to IND and first in human trials is essential. Filing experience will be highly advantageous.
  • Ability to ensure high quality in the design, development, execution, statistical analysis, clinical interpretation and reporting of clinical studies.
  • Ability to ensure an investigation is conducted according to GCP regulations and internal control documents in order to protect the rights, safety, and wellbeing of subjects and the accuracy and validity of the trial data.
  • A proven track record of effectively applying medical expertise to make good clinical decisions in accordance with appropriate Standard Operating Procedures.
  • Demonstrated understanding of the critical importance of rigorous data generation and disciplined stewardship of the data.
  • Demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients.
  • Ability to produce written scientific communications with clarity, accuracy and rigor.
  • Ability and strong desire to “make things happen.” A results-oriented work ethic and a positive, can-do attitude.
  • 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.

SKILLS & ABILITIES:

  • Good judgment, strong follow up, organizational, analytical, and problem-solving skills, including the ability to make complex decisions and willingness to defend difficult positions.
  • A strategic and innovative thinker with a high degree of self-initiative.
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
  • Effective leadership and people management skills and a team-oriented style are essential.
  • Excellent written and oral communication skills. Ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.
  • A flexible, creative and resourceful style and attitude is required. Must be open to change and the unknown with the ability to shift gears quickly.
  • Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
  • Ability to multi-task, meet deadlines and set priorities.
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (20-30% travel expected).