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Position Overview:

The successful candidate will be a member of the clinical development team, working closely with other members of the medical research group in clinical development (medical monitor, statistician, and clinical pharmacologist, translational research) to support investigations that deliver the development strategies for one or more therapies across the portfolio. The successful Clinical Scientist contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. In addition, the Clinical Scientist will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies.

Responsibilities:

• Working as part of an integrated clinical development team, you will contribute to the clinical strategy and creation of the clinical development plans for one or more drugs.
• Contributing to key strategic documents including protocol concepts and full protocols for product(s).
• Contributing to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities questions.
• Reviewing and summarizing relevant literature on the clinical development programs.
• Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
• Support investigators meetings and protocol training meetings.
• Performing medical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.
• Help coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators.
• Providing support to advisory boards, steering committee meetings, consultant meetings and investigator meetings, including preparation and delivery of presentations.
• Proactively seeking out and recommending process improvements.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Author/review abstracts, presentations, and manuscripts for external publications.

Qualifications:

• Master’s Degree, PhD, PharmD, or M.D. with clinical trial/drug development Phase 1-3 expertise highly desirable.
• The ideal candidate will have 8+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization.
• The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize.
• Proven experience in developing effective relationships with key investigators.