Associate Director/Director, Clinical Development - Thinknicity

Position Description

Job Number: F2736

Title: Associate Director/Director, Clinical Development

Reports To: Senior Director/Vice
President, Clinical Development

Location: San Francisco, CA

Contact Details:
· Kristin Clevenger
· (415) 247-7700.
· kristin@thinknicity.com

Eligibility Requirements
· Relocation expenses are not available for this position.
· No resumes from third party agencies representing their own candidates.
· Position cannot entertain candidates requiring visa-transfer or sponsorship.

Thank you.

Job Description:
The Associate Director, Clinical development will work in a project team environment on late phase clinical trials of a novel therapeutic for a neurodegenerative disease indication. Internally, s/he will interface directly with clinical operations, regulatory affairs, biometrics, medical affairs, and other physicians within clinical development to ensure proper design, monitoring, and oversight of clinical trials. Externally, s/he will be a liaison to investigators and key opinion leaders and participate in reporting and presenting clinical trial data.
Principal Duties and Responsibilities:
· Serving as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data and safety surveillance
· Addressing and resolving medical/safety/eligibility questions from participating clinical trial sites
· Participating in the planning and management of investigator meetings, advisory boards and other scientific committees
· Providing strategic input into clinical/regulatory development plans
· Writing/reviewing clinical trial protocols, study reports, and international regulatory documents
· Participating in the selection and management of contract research organizations (CROs) and other vendors
· Collaborating with pre-clinical and translational medicine colleagues in assessing the potential of new compounds for development
Education & Experience:
· M.D./D.O. degree required, subspecialty and board certification in neurology/psychiatry preferred
· Prior training and experience with Good Clinical Practice (GCP)
· A minimum of two years industry experience
· Excellent verbal and written skills
· Ability to work collaboratively in a dynamic environment

How to Apply

Application Instructions / Send a Resume