• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Senior Director, Clinical Development

Job Number: 25176

Location:

Job Description

The Senior Director, Clinical Development is responsible for the designing, implementing, and undertaking clinical trials during the research process. He or she is required to ensure that the quality and the reliability of clinical data are maintained. The incumbent must also ensure that the clinical research is conducted in a safe and secure work environment that adheres to the numerous safety guidelines. The Senior Director, Clinical Development coordinates with the other members of the research team, which includes representatives from clinical operations and the researchers. He or she is responsible to liaise with the company management team, various vendors, and study investigators at participating sites.

Responsibilities

Duties and Responsibilities

  • Assist in building a team of clinical scientists based on expanding program needs
  • Provide mentoring to and leadership for junior clinical scientists
  • Review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information
  • Developing and reviewing study protocols and protocol amendments
  • Contribute relevant clinical sections to documents such as the IB, DSUR or INDs
  • Responsible for drafting reports, abstracts, posters, CSRs and presentations on the various findings of the clinical research
  • Providing senior management personnel regular updates on the progress of the clinical research
  • Lead dose escalation calls for phase 1 studies and/or safety review meetings
  • Perform regular review of clinical data to ensure safety procedures are followed, efficiency is maintained, and lab data are accurate and correct

 

Required Skills

Qualifications
The Senior Director, Clinical Development must hold a Bachelor of Science degree from an accredited educational institution. Additional training in bio life sciences with an advanced master’s qualifications is preferred. Training through internships that provide knowledge on ICH, GCP, and other relevant regulatory guidelines is advantageous.

  • At least 10 years previous experience in large pharma and/or biotech sectors
  • Prior experience either mentoring or managing other clinical scientists is required
  • Ability to write clinical protocols
  • Ability to perform relevant literature reviews, succinctly summarize results from the literature review and apply results to the program
  • Analytical capabilities
  • An eye for details
  • Time management skills
  • Strong communication and interpersonal abilities
  • Ability to interact with scientists (both internal and external), clinical investigators and other medical experts
  • Capable to read and understand clinical information
  • Willing to travel

 

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