Clinical Research Medical Director, Bone Health California
Tanner & Associates is recruiting a Clinical Research Medical Director in Bone Health for a large biotech company based in California.
Please send CV to [email protected].
Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
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 / 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 Endocrinology, Rheumatology, Orthopedic Surgery, board certified or equivalent.
- Clinical research experience in the biopharmaceutical industry, biotechnology, and pharmaceutical sectors.
- 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.
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