Clinical Development Medical Director – Breast Cancer

Summary
Associate Global Program Medical Director / Clinical Scientific Director (CSD)
 
The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase)
 
Major Activities:
1) Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
5) May be the Program Manager of other associates (e.g., CSE).
 
IDEAL BACKGROUND:

Education:
MD or equivalent medical degree required.
Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred;
Clinical practice experience ≥ 4 years (including residency) preferred
 
Languages: Fluent English (oral and written)
 
Experience:
 ≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
 Advanced knowledge of assigned therapeutic area
 Demonstrated ability to establish strong scientific partnership with key stakeholders
 Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
 People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
 Excellent communication skills, written and oral
 Strong interpersonal skills
  Excellent negotiation and conflict resolution skills