Ink staffing

Medical Director (and Senior Medical Director)

Ink staffing - South San Francisco, CA

  • Design and optimize clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the clinical development team
  • Serve as medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the clinical operations team
  • Serve as primary medical contact for ongoing large-scale trials providing appropriate clinical guidance to both internal (Clinical Operations) and external (CRO) stakeholders to ensure program objectives are met in accordance with the medical plan
  • Lead integrated, cross-functional team and provides vision and oversight of project execution; ensures appropriate integration and representation of all R&D functions in support of assigned priority assets
  • Responsible for preparing company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally
  • Establish and implement exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators
  • Interact with study investigators, thought leaders, including advisory boards, academicians, and internal colleagues
  • Ensure adherence to Company’s Standard Operating Procedures
  • Maintain clinical and scientific awareness in area of expertise.

 

 

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

 

  • An M.D. or combined M.D. / Ph.D.
  • 5+ years of industry experience designing, leading and managing clinical studies. Experience in rare disease or gene therapy preferred. Level will be dependent upon experience.
  • Demonstrated understanding of the drug development process.
  • Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
  • Ability to effectively evaluate outside expert advice.
  • Ability to communicate and explain technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
  • Ability to work independently.
  • Experience working effectively in a fast-paced, team-based environment.

 

 

OTHER QUALIFICATIONS:

 

  • Strong clinical/scientific/technical skills.
  • Strong interpersonal capabilities.
  • Ability to anticipate and resolve problems effectively.
  • Strong verbal communication and technical writing skills.
  • Ability to present clearly using scientific and clinical terminology
  • Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
  • Sound organizational skills.
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • Motivates team members; fosters and nurtures teamwork.
  • Project management skills and focus on delivery of results.
  • Ability and willingness to travel at least 25% of the time (domestic & international medical meetings, functions etc)


Posted On: Thursday, May 28, 2020



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