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Associate Medical Director, Neuromuscular Disorder, ECD Cambridge United States,
Posted on : 07 June 2017
- The position of Associate Medical Director/ Medical Director, Clinical Development sits in the Neuromuscular Therapeutic Area - a component of the Research and Early Clinical Development Organization.
- The new Associate Medical Director will support one or more development programs involving products in ALS or other neuromuscular disease.
- The initial focus will be in designing and executing clinical trials in early development.Activities include direct responsibility for advancing high priority clinical programs through clinical study design and execution, development of biomarker strategies, as well as interpretation of data from key clinical studies.
- The individual who assumes this position will interact with multiple levels of management within the company, external stakeholders in the medical community, along with global regulatory authorities.
Two positions are available for this role.
- The Associate Medical Director has the following responsibilities:
- Provide strategic leadership for programs that integrate the individual s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world.
- Execute an early stage development program in ALS.
- Integrate the scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, 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.
- Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- As required, establish external collaborative relationships to augment internal company capabilities in support of early-phase development programs
- Contribute to the development of strategic initiatives and specified Business Development activities.
The ideal candidate will have the following mix of professional and personal characteristics:
- One (1) to Three (3) years of experience in clinical research (Medical Director will require significantly more experience)
- Industry experience in clinical development preferred, but not required for Associate Medical Directors
- Capacity and willingness to work effectively across disease areas.
- 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
- MD, PhD, MD / PhD or DO credentials
- 2. Neurology training with sub specialization in Neuromuscular Disease and/or other degenerative CNS disorders preferred
- 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.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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Cambridge MA US
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