| Job Description | The Medical Director will provide medical leadership and content expertise in collaboration with Product Development, Commercial, Regulatory, Clinical Operations and other cross-functional team members, to ensure successful completion of all clinical activities, data analysis and interpretation. This position is located in Emeryville and reports to the Senior Vice President, Product Development.
Specific responsibilities:
Medical Monitor for Adamas-sponsored clinical trials.
Participate in long-range strategic planning for products in development.
Establishes and approves scientific methods for design and implementation of clinical protocols.
Adverse event safety monitoring and reporting.
Develop study protocols in collaboration with the clinical operations department.
Organize and lead protocol steering committees.
Recruit and motivate clinical investigators.
Presentation of technical information to internal and external personnel.
Contributes to Clinical Study Reports, NDA reports, and other clinical/regulatory/safety documents.
Manage external presentation of data (e.g. publications, scientific meetings).
May act as a consultant/liaison with other corporations when working under licensing agreements.
Regularly report to senior management team key study metrics including, enrollment status, data quality and safety.
Ensure study compliance by understanding and applying all relevant SOPs and GCPs.
Represent Clinical Research as a member of trial teams.
Qualifications:
Requires an M.D. or equivalent, Neurology speciality preferred.
Minimum 5 years’ experience in clinical trials is preferred, either within an academic environment or within the biopharmaceutical industry.
Strong written and verbal communication, interpersonal, problem solving and negotiation skills. Ability to effectively participate in multi-disciplinary teams.
Excellent presentation skills; ability to present to diverse groups, both internal and external experts.
Proven organizational skills; ability to manage multiple priorities and work under pressure.
Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies.
Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio.
Ability to travel |
| | Company | | Adamas Pharmaceuticals, Inc. | Job Code | | State or Province | | California | | |
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