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Medical Director – Clinical Research
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Major Responsibilities Include:
Medical oversight for ongoing clinical trials throughout conduct and support all medical and scientific aspects of clinical trial(s).
Contribute to the strategic planning, authoring, and review of clinical and regulatory documents.
Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information and the commercial organization.
Maintain close collaboration and cooperation with Clinical Operations on the implementation and execution of clinical studies.
Contribute to the strategic planning and execution of clinical development plans.
MD degree with at least 5 years of direct biotechnology or pharmaceutical industry experience in Clinical Research.
Prior experience in Hepatology, Gastroenterology, Metabolic Diseases, or related field, preferred.
Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
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