Athira Pharma Seattle, WA
- Posted: over a month ago
- Benefits: life insurance, medical, vision, 401k, dental
Position: Medical Director
Regions: Seattle/Bothell, WA
Hiring Manager: CMO
Our mission is to restore lives by advancing bold therapies, thoughtfully and urgently. We are working to provide better care for people through innovative research and accessible products. Using our platform of disease-modifying regenerative small molecules, our current focus is on neurological diseases. An estimated one billion people around the world suffer from neurological disorders including Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, and more. With both a discovery arm and a research and development arm, we are positioned to lead the development of disease-modifying, life changing therapies addressing one of the largest and most critical unmet medical needs today.
About this role:
Athira is seeking a full-time Medical Director with clinical and drug development experience. The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators. The Medical Director will be responsible for various medical development aspects covering drug safety, regulatory, protocol development and reporting.
Position & Scope:
• Reports to the CMO; lead medical development plan on one or more early to late-phase projects.
• Serves as medical lead at the study and indication level.
• Provides medical inputs and supports an internationally viable medical program resulting in quality regulatory submissions.
• Provides medical leadership on the Project Team; collaborates with other project team members and study team(s) to ensure delivery and quality of clinical trials.
• Responsible for the medical interface with drug discovery, regulatory and commercial colleagues.
• Lead and support Drug Safety and Pharmacovigilance in clinical trial conduct, in cooperation with CRO Medical Monitors
• Interacts with clinical sites and investigators as needed to support safety management and study compliance
• Keep senior management informed of critical clinical developments
• Accountable and responsible for medical and safety aspects of clinical development, including clinical trial design, implementation, and data reconciliation and interpretation.
• Lead medical and regulatory related SOP development to ensure compliance with Good Clinical Practices (GCP)
• Provides medical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents. Support regulatory planning, and agency discussions; attend regulatory agency meetings as needed
• Support business and corporate development, internal training
Contributes to clinical documents:
• Protocols, IBs, study reports, statistical analysis plans, ISE/ISS, DSURs, publications, CSRs and clinical sections of regulatory submissions
• Organizes for clinical expert panel meetings and advisory boards, deducts actionable results
• Medical Degree (MD) with post graduate qualification; specialization in CNS disorders, such as neurology and neuropsychiatry preferred.
• Should have at least 3 years relevant experience in medical and safety roles at a R&D based biotech/pharmaceutical company, CRO, or academic clinical research centers.
• Significant and demonstrable working-knowledge of regulatory procedures and ICH/GCP guidelines (global scope)
• Proven track record in clinical study design, monitoring, execution, and reporting
• Comfortable and successful working independently in small teams in a matrixed environment
• Exceptional attention to details and quality
• Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
• Able to effectively interface and collaborate with clinical research, operations, regulatory, and other disciplines.
• Current authorization to work in the US
• Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing clinical team.
• Excitement about the vision and mission of Athira as we build a company that is a leader in neuronal CNS and peripheral disorders.
Athira is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.
Athira PharmaWhy Work Here?
Advancing New Therapies for Neurodegenerative Diseases
Athira Pharma is a drug development company striving to improve human health by advancing new therapies for neurodegenerative diseases like Alzheimer’s and Parkinson’s. Our innovative approach is focused on turning brain degeneration into regeneration, achieved by re-establishing lost connections and restoring lost function.
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