Senior Principal Scientist

Senior Principal Clinical Scientist - Direct Hire!

The Senior Clinical Scientist will plan, coordinate and execute project-specific clinical research tasks relating to the evaluation and development of new therapeutic products.

Responsibilities include:
- Providing specific contributions to the elaboration of product-specific development plans.
- Developing individual clinical trial designs and generating protocols. Interprets study outcomes and produces final integrated reports.
- Defining timelines for individual studies and tracking progress against agreed schedules. Identifying the reasons for major deviations and recommending solutions.
- Handling all clinical and regulatory interactions with the external CROs or study sites including the review and approval of monitoring reports. Managing all site audit activities, reviewing outcomes, and recommending corrective actions.
- Developing scientific programs for Investigator Meetings. Selecting presenters and actively participating in meetings. Contributing to the preparation of Investigator Brochures.
- Recommending individual study site selection and collaborating in developing appropriate monitoring plans. Reviewing advertising material and informed consent templates. Handling interactions with local and central institutional review boards, as appropriate.
- Handling the internal processing of serious adverse events and managing study specific coding activities. Proposing global and project-specific changes to coding dictionaries.
- Providing input for the development of study-specific CRFs and statistical analysis plans. Reviewing and commenting on outside laboratory and other vendor selections.
- Providing specific input and assisting in development of clinical sections of regulatory submissions, responses to FDA requests and annual reports.

The ideal candidate will possess a Ph.D, MD or PharmD and eighteen years related pharmaceutical experience, or an equivalent combination of education and experience as well as knowledge of current clinical research practices and procedures; principles and practices of therapeutics and pharmacokinetics; federal regulations and guidance concerning the conduct of clinical research including GCPs; basic knowledge of statistical principles and their application to clinical research; and Business English usage - including spelling, grammar and punctuation.

For immediate consideration, 'Apply Now'. . .Kelly Services is an Equal Opportunity EmployerContact?Information?:.111 Anza Blvd
Burlingame?CA?94010