Senior Director Clinical Physician


Position Title: Senior Director, Clinical Physician

Requirement Description:  The Clinical Research Physician, Therapeutic Area will be instrumental in supporting the growth of the Company's Therapeutic Area infrastructure as the organization continues to build the value of the current products and develop new products. The incumbent will have hands-on responsibility designing and executing clinical trials, and running  programs focused on Therapeutic Area, and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development.  This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science.

Responsibilities will include:
- Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards.
- Lead the Clinical Protocol Team, including interactions with discovery, safety, marketing, regulatory, research and other functions.
- Write protocols that are in-line with the overall indication strategy
- Present at Investigators’ Meetings
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Have responsibility for the quality, coordination, medical accuracy and timeliness of clinical study reports.
- Work with Therapeutic Area Head and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.
- Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
- Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and CLIENT Senior managers and department heads across the corporation
- Ensure adherence to GCP/ICH and CLIENT Standard Operating Procedure (SOP) standards.
- Maintain clinical and scientific awareness in area of expertise
- Guide and possibly manage the day to day work of Clinical Research Scientists.
- Manage lifecycle requirements and plans for designated indications.

- Minimum M.D. or PhD degree and substantial medical/clinical training in Therapeutic Area or a related field.
- Minimum 3-5 years of experience designing, leading and managing significant clinical trials in the Therapeutic Area
- Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.
- Understanding of drug development process.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Experience in designing Clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Experience in Clinical project planning.
- Experience working on global and complex Clinical trials.
- Experience working effectively in a team/matrix environment.

Duration: Available upon request

Location: Available upon request