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Medical Director

Employer
Neuraly, Inc.
Location
Germantown, MD
Closing date
Oct 19, 2019
Position The Medical Director provides leadership and direction for the pipeline of clinical development programs for Neuraly and is responsible for the strategy, direction and execution of the company's clinical development plans. This role is a key member of the senior leadership team which determines and oversees research and drug development and sets the overall strategic direction of the company. This is a unique opportunity to be a major contributor to the success of a well-positioned, stable, growth orientated biotech/bioscience company. Responsibilities Establish & execute the clinical development strategy for one or more compounds from lead development in discovery, Phase I-III clinical trials, and through registration. Responsible for the design and development of clinical study concepts. Provides scientific and clinical input to study related plans and protocols. Will serve as the internal medical expert for the review, presentation, and interpretation of clinical study Maintain high level of clinical and scientific expertise in the disease area(s) by reviewing literature, attending scientific meetings, and through personal exchanges with thought leaders, investigators and internal team members. Present at global scientific meetings representing the company and collaborate with cross-functional teams and thought leaders to meet publication objectives. Responsible for product safety profile(s), manage safety issues in clinical trials and ensure that the clinical trial is conducted according to the protocol guidelines and all applicable regulations. Will serve as the primary Medical Monitor responsible for monitoring safety of all subjects enrolled in clinical trials. Provide direction and participate in the selection of study investigational sites and maintain relationships with investigators and key opinion leaders. Authors clinical sections of INDs, NDAs and other regulatory documents. Experience & Qualifications Must hold a current, active unrestricted license to practice medicine Must be board certified / eligible by a specialty board approved by the American Board of Medical Specialties. Medical Director with a minimum of 5 years of clinical research experience with neurological diseases. Strong regulatory background in order to establish the clinical development strategy of our products. Knowledge of clinical research experimental design, including fundamental understanding of statistical principles Knowledge of state and federal laws and FDA regulations governing the healthcare, Clinical Research and Pharmaceutical Drug Development industry needed. Ability to apply technical expertise and make sound decisions

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