Clinical Research Director

4 weeks ago

New York, New York, United States Cellectis Full time
Job Title: Director, Clinical Research Scientist

Cellectis is seeking a highly experienced and skilled Director, Clinical Research Scientist to join our Clinical Development Organization. As a key member of our team, you will play a critical role in the evaluation, strategic planning, design, and execution of our clinical-stage programs.

Key Responsibilities:
  • Support the clinical development of assigned programs and participate in the design and implementation of the development strategy.
  • Provide strategic clinical science support for assigned studies and programs.
  • Support the design and execution of assigned clinical trials and/or programs, working closely with clinical operations study lead and cross-functional study team members.
  • May co-lead study team meetings in partnership with Clinical Operations study lead.
  • Support clinical/medical monitoring and associated documentation, attending and representing the clinical sciences organization on various sub-teams or forums.
  • Act as primary point-of-contact for clinical study or program for clinical science-related activities, conduct ongoing medical/safety data reviews, and provide clinical science inputs into study reporting.
  • Collaborate cross-functionally to develop Protocol and ICF documents/amendments and present these to governance committee and early clinical development team meetings as required.
  • Work independently and exercise judgment in resolving critical problems not always covered by existing standards, policies, and procedures.
  • Develop and/or provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications.
  • Provide clinical contributions to internal documents and presentations, including clinical study reports and clinical portions of Regulatory Documents.
  • Participate in and/or lead the ongoing development and/or enhancement of clinical development processes, structures, systems, tools, and other resources.
Requirements:
  • Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or similar scientific field preferred).
  • Minimum of 10-15 years pharma/biotech industry experience; or relevant equivalent clinical; or relevant laboratory research experience.
  • Minimum of 6 years' experience with clinical trials.
  • Relevant therapeutic area experience preferred.
  • Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall global drug development process.
Technical Skills:
  • Strong interpersonal, verbal communication, and influencing skills.
  • Outstanding written communication skills.
  • Strong analytical and presentation skills.
  • Comfortable working in a fast-paced entrepreneurial environment and maintaining a flexible mindset.
  • Proven ability to work independently and in a team setting.
  • Ability to travel up to 20%.
Physical Requirements:
  • In-office 4 days per week, required.
  • Sedentary, desk position.
Salary Range:
  • $150,000-175,000 (final salary is dependent on candidate's experience and credentials).

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