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TANNER & ASSOC INC

Clinical Research Medical Director, Nephrology – California

TANNER & ASSOC INC, California, Missouri, United States, 65018


Clinical Research Medical Director, Nephrology – California

Tanner & Associates is recruiting a Clinical Research Medical Director in Nephrology for a large biotech company based in California. Please send CV to careers@biotechsearch.com.Summary:

The Company is strengthening its focus on Nephrology and is seeking to fill several key positions to work on various programs in early and late stage clinical development.Key Responsibilities:Supporting the development, execution and communication of the global scientific/medical evidence plan.Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.Supporting the development of key scientific external relationships with opinion leaders.Participating and providing clinical input into safety and regulatory interactions.Providing clinical and medical support for filing and approvals of molecules in expansion countries.Providing clinical/scientific input during the development and execution of clinical trials.Interpreting clinical trial data.Participating in conducting safety assessments.Participating in interactions with regulatory agencies.Authoring clinical study reports, publications and regulatory submissions.Developing key opinion leaders and making scientific presentations at advisory boards, key scientific meetings and external committee meetings.Identifying new clinical research opportunities.Supporting in-licensing and out-licensing activities and partner relationships.Supporting product lifecycle management for new indications.Qualifications:MD with 2 or more years of clinical research and/or basic science experience combined with clinical teaching and patient care activities; 5 or more years is preferred.MD plus accredited residency in Nephrology, board certified or equivalent.Clinical research experience in the biopharmaceutical industry, biotechnology, and pharmaceuticals.Demonstrated ability to serve as a medical expert in a complex matrix environment.Medical/Scientific Knowledge:In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.Familiarity with basic concepts of clinical research and clinical trial design, including biostatistics.Knowledge of GCP, FDA and EMEA/CHP regulations and guidelines and applicable international regulatory requirements.Please send a CV and contact information to Jake Tanner at careers@www.biotechsearch.com. US candidates only please.

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