At Athira, we are focused on improving neuronal health by promoting natural repair systems. Our therapeutic approach involves small molecule treatments designed to work by targeting specific, naturally occurring repair mechanisms. One of our initial targets is HGF/MET, a critical repair pathway we are seeking to promote with our lead therapeutic candidate, ATH-1017. We believe that boosting this pathway can help improve brain health and function. 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.
About this role:
Athira is seeking a full-time Medical Director with clinical and drug development experience who will provide medical and scientific support to clinical research programs, study teams, and investigators. In this role you will be responsible for various medical development aspects covering drug safety, regulatory, protocol development and reporting. Our ideal candidate believes there is beauty in simplicity and has a desire to join a transformative organization seeking to leverage our combined experiences with new ideas and approaches. 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. To achieve this mission, we need a Medical Director with the tenacity to find a way, or make a way and someone who will foster collaboration throughout the organization and with our external partners.
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. Preference for specialization in CNS disorders, such as neurology and neuropsychiatry.
- Should have at least 3 years relevant experience in medical and safety roles with at least 1 year at a R&D based biotech/pharmaceutical company, academic clinical research centers, or CRO.
- Proven track record in clinical study design, monitoring, execution, and reporting.
- Comfortable and successful working independently in small teams, with the flexibility to support various projects as an integral leader and provider of medical science expertise.
- Solutions oriented mindset with exceptional attention to details and quality. Proactively identifies and resolves issues to advance our programs.
- Outstanding communication and organizational skills with 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 in support of innovative solutions and forward-thinking clinical trial design.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing clinical team.
- Demonstrates tenacity in pursuit of goals and fosters collaboration throughout the organization and with our external partners.
- Believes there is beauty in simplicity and has a desire to join a transformative organization seeking to leverage our combined experiences with innovative ideas and approaches.
- Excited about the vision and mission of Athira as we build a company that is a leader in neuronal CNS and peripheral disorders.
- Current authorization to work in the US
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.