Clinical Research Medical Director, Nephrology – California
22 hours ago
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.
- 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@ US candidates only please.
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