Tanner & Associates is recruiting a Clinical Research Medical Director in Nephrology for a large biotech company based in California. Please send CV to firstname.lastname@example.org
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.
- 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
- 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.
- 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 email@example.com . US candidates only please.
Tanner & Associates