Clinical Research Medical Director, Nephrology - California, United States - TANNER & ASSOC INC

Description

Clinical Research Medical Director, Nephrology – California | Biotech

Clinical Research Medical Director, Nephrology – California – Biotech

Clinical Research Medical Director, Nephrology – California

Clinical Research Medical Director, Nephrology – California

September 23rd, 2019 by admin

Tanner & Associates is recruiting a Clinical Research Medical Director in Nephrology for a large biotech company based in California.

Please send CV to

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

Based on the needs of the Therapeutic Area, this role may be required to provide clinical and medical support for filing and approvals of molecules in expansion countries.

Provide clinical/scientific input during the development and execution of clinical trials
Interpret clinical trial data
Participates in conducting safety assessments.
Participates in interactions with regulatory agencies.
Authors clinical study reports, publications and regulatory submissions
Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings
Identify new clinical research opportunities
Support in-licensing and out-licensing activities and partner relationships
Support 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 pharmaceutical
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.
Familiar 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

. US candidates only please.
Thanks,
Jake Tanner
Tanner & Associates

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