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Director, Executive Director, ...
Director, Executive Director, Clinical Research(Urology)
This position will have a hands-on role driving the development of one or more compounds in clinical development, and serve as a key member of cross-functional development teams. This individual will be responsible for and contribute to the development of clinical development plans, protocols and clinical study reports. He/she will be responsible for conducting the activities required to develop, implement and monitor multiple clinical trials and ensure that Good Clinical Practices (GCP) are followed. In addition, this colleague will lead and contribute to the preparation of high quality regulatory applications for drug approval. He/she will be responsible for implementing successful clinical programs that are completed on time.
· Actively participate in the medical and operational aspects of ongoing development projects to ensure corporate goals of time, cost and quality performance expectations are met.
· Develop and review protocols and interact with key external opinion leaders regarding protocol development.
· Play a leadership role in managing multiple clinical research trials across all functional areas of the drug development process.
· Collaborate effectively cross functionally.
· Develop and review protocols and interact with key external opinion leaders regarding protocol development and development strategies.
· Identify and develop collaboration relationships with key investigators globally.
· Conduct investigator meetings, advisory boards and site visits.
· Implement and supervise clinical trials, including requests for eligibility.
· Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of AEs, SAE and protocol deviations.
· Address and troubleshoot any medical issues arising at clinical sites.
· Interact with data management to support data collection and ongoing medical review.
· Demonstrate strong leadership and collaborative interpersonal skills.
Drug Development Responsibilities
· Interact with senior management and product teams regarding drug development strategies and plans.
· Represent the company to external audiences in the medical, financial, and pharmaceutical industry communities.
· Interact with investigators and key opinion leaders regarding protocol development and indication strategies.
· Write protocols, IB, clinical study reports, abstracts, manuscripts, annual reports.
· Write clinical sections of IND and NDA submissions.
· Help create budgets and progress reports; complete other administrative tasks as required.
Skills, Education and Experience:
· Highly motivated, committed, enthusiastic colleague with a collaborative, “can do” attitude.
· Requires a Medical Degree, specializing in Urology.
· 3 to 5 years experience in the pharmaceutical industry. Urology required.
· Able to work independently, prioritize tasks efficiently and meet expected time frames.
· Able to perform thorough reviews of various medical and legal records in a timely manner.
· Knowledge of safety reporting principles, including FDA safety reporting regulations.
· Knowledge of industry compliance guidelines.
· Excellent writing and presentation skills.
· Able to interact and collaborate professionally with various departments, regulatory agencies and investigators.
· Must be flexible and available to work in the evenings and weekends, as required.
Position Location and/or Territory and Travel
· Position is located in Irvine, CA.
· Position will require travel.
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