- 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.

Knowledge 

• · 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.

Skills

• · 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.