Sr. Director, Medical

Sr. Director, Medical
Department :  CD&RA
Working Place :  US
Recruitment :  1
Nature Of Work :  Full-Time
Working Years Of :  >10 Years
Minimum Academic :  Doctor
Release Time :  15 Oct, 2019

Job Responsibilities
Development of protocols for clinical studies;
Preparation of clinical development plans;
Drafting of clinical scientific documents such as clinical section of IND, IND amendments Investigator Brochures, Annual Reports, Clinical Study reports, safety update reports and other FDA submissions, Risks / benefits analysis for applicable documents;
Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies. Provide scientific expertise for selection of investigator and vendors. Monitor, review and summarize safety and efficacy data in ongoing studies;
Assist with study design for exploratory development;
Will lead the clinical matrix teams for assigned compounds;
Represent exploratory development on project teams;
Develop relationships with appropriate consultants, contribute to or perform therapeutic area/indication research and competitor analysis;
Interpret clinical data, prepare abstracts and present data at scientific meetings, both internally and externally;
Support budget planning and management;
Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.

Minimum Requirements
A medical degree (M.D./Ph.D, M.D., D.O., or equivalent) with significant scientific research experience required;
Minimum of 10 years of experience in clinical research (including medical affair) with at least 5 or more years of drug development experience within other biotech / pharmaceutical companies are required;
Prior industry Oncology Drug Development experience a plus, specifically experience in conducting phase I/II clinical trial and deep understanding of relevant regulatory health authority expectations and regulations;
Ability to multi-task and work in a fast-paced environment;
Excellent written and oral communication skills;
Knowledge of GCP and ICH guidelines;
Strong Analytical ability;
Flexibility to work with colleagues in multiple geographic locations;
Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred;
Experience with the development and support of related SOPs and policies is expected.