Medical Monitor (closed)
- · Conceives, implements, and analyzes drug development programs, including:
- Understanding pharmacology of drugs and unmet medical needs.
- Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
- Working with experts and consultants in the field to refine a clinical development strategy.
- Designing clinical trials for the purpose of meeting specific objectives.
- Anticipating and addressing future commercial and clinical development needs, based on the clinical character of the compound.
- · Implements clinical development programs, including:
- Co-authoring global clinical development plans with all practical elements.
- Leading and motivating the clinical development team to operationalize the clinical develop strategy, i.e., clinical trials management.
- Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
- Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
- Developing and leading formal presentations of results to the medical community, in written, verbal, and visual formats.
- · Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
- · Partners with biostatistics, medical writers, and external consultants to understand and present the results of clinical development programs.
- · Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
- · An advanced understanding of clinical medicine and science.
- · Advanced understanding of drug development principles and clinical trial implementation and management.
- · Complete understanding of the global regulatory requirements.
- · Working knowledge of marketing and commercialization.
- · Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
- · Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
- · Demonstrated experience in successful regulatory filing.
- · Ability to work across different therapeutic areas and different stages of clinical development.
- · Strong communication and presentation skills.
- · Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- · Knows how/when to apply organizational policy or procedures to a variety of situations.
MD (or equivalent) or PharmD
10 years of clinical research experience preferred, 6 years may be acceptable depending on profile.
Prior management experience helpful.