Seeking an individual with an MD or DO degree to fill an open position at the Director or Sr. Director level reporting to the Vice-President of Clinical Pharmacology and Experimental Medicine. The job will focus initially on representing clinical pharmacology or clinical development on early project teams from clinical candidate nomination and implementing all clinical studies up to POC. Must have experience designing and conducting phase 1 and 2 studies. The person may also provide medical and safety input and serve as a medical monitor during live-phase of the study. The candidate must have experience or potential to serve as a project team leader for cross functional teams.
Major Duties & Responsibilities:
- Conduct and supervise clinical studies, analyze results, write study reports.
- Contribute to the clinical sections of regulatory documents such as the IND, NDA.
- Interact with regulatory agencies throughout the development process.
- Apprise senior management of progress and developmental issues.
- Interface with contributing groups such as Safety Assessment, Pharmaceutical R&D, Process Chemistry R&D, Regulatory Affairs and Quality, Project Planning, and Clinical & Medical affair.
- Organize consultants to ensure development activities are in line with current medical knowledge.
- Interact with external vendors and clinicians.
- Serves as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation.
- Background from a pharmaceutical, biologic, biotechnology or contract research organization. Three or more years of pharmaceutical industry experience with relevant drug development focus.
- A demonstrated ability to create and implement drug development strategies resulting in efficient product approvals including experience in submitting an NDA.
- Training in Good Clinical Practice, SOP’s, relevant software applications and clinical monitoring is helpful. Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience.
- Knowledge of clinical trial management, data management, and drug development process.
- MD or DO degree (PhD or PharmD with 10+ years of drug development experience may be considered). Training in Clinical Pharmacology and/or Translational science is highly desirable.
- A detailed understanding of human pharmacology, biochemical medicine and the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drug(s) being developed.
- A proven track record of working effectively on cross-functional development teams.
- Demonstrated problem solving ability in addressing current and anticipated issues related to clinical trial management as well as medical and regulatory development.
- Comfortable working in a liquid, fast-paced, highly dynamic and matrixed environment.
- Excellent oral and written communication skills, as well as interpersonal skills.
Theravance, Inc. - 2 years ago