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Medical Director, Clinical Development Cambridge United States,
Posted on : 02 June 2017
- Provide strategic leadership for the clinical programs that integrates both the individual s extensive knowledge in the disease area and the medical and advocacy community around that world and the commercial, research, regulatory, and medical research goals and needs of the corporate activities in the disease area.
- Oversee development of clinical activities for one key immunology and/or fibrosis asset and possibly other drug development studies within a therapeutic area in collaboration with the clinical development teams.
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).
- Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.
- Lead strategic initiatives and clinical program team(s), including Medical Directors, Clinical Program Leaders (CPLs) and / or Clinical Scientists and Clinical Trial Managers (CTMs).
- Manage clinical program budget(s) within stated financial goals.
- Develop and maintain relationships with program counterparts in Commercial, Research, Safety, Medical Regulatory, and Medical Affairs.
- Contribute to the development of strategic initiatives, specific Business Development activities and overall lead various organizational initiatives in Clinical Development.
Five (5) years of experience in clinical or laboratory research.
- Industry experience, particularly in development within the disease area (neurodegeneration), is desirable
- Five (5) years of progressive responsibilities in drug development, and a proven track record for clinical and scientific leadership in drug development are ideal.
- Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
- Demonstrated strategic and critical thinking.
- Excellent communication skills (oral and written) and excellent organizational skills.
- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission:
- making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
Job Segment: Manager, Biotech, Laboratory, Product Development, Management, Science, Research
Cambridge MA US
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