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TLL Pharma, High Impact Medicines for All.  Director of Formulation Development
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Position:
Medical Director

Employer:
TLL Pharma, High Impact Medicines for All.

Description:

Medical Director

  • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements.
  • Oversees project-related education of investigators, study site personnel, and TLL study staff.
  • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events and regulations for those protocols on which assigned.
  • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
  • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity.
  • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.


Qualifications/Experience:

Qualifications

  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with gastroenterology in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
  • At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
  • Ability to run a clinical research program of moderate complexity with minimal supervision.
  • Ability to perform and bring out the best in others on a cross-functional global team.
  • Ability to interact externally and internally to support a global scientific and business strategy.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.

Must possess excellent oral and written English communication skills.



Location: USA or China

Contact: If interested, please send your resume to info@TLLpharma.com

Post Date: 8/4/2021 10:36:00 AM
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