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Senior Manager Clinical Operations
2 months ago
Autobahn Therapeutics, Inc. is a biotechnology company focused on developing innovative treatments for CNS disorders. Our mission is to improve the lives of people affected by these conditions.
Job SummaryWe are seeking a highly experienced Senior Manager Clinical Operations to join our team. This individual will be responsible for overseeing clinical pharmacology studies, including Phase 1, 2, and 3 trials. The successful candidate will have a strong background in clinical trial management, with experience in the biotech industry.
Key Responsibilities- Study Oversight: Provide sponsor oversight of clinical study conduct, ensuring compliance with Autobahn SOPs, FDA/EMA regulations, and ICH/GCP guidelines.
- Clinical Pharmacology Studies: Oversee clinical pharmacology studies, including Phase 1, 2, and 3 trials, with a focus on quality and compliance.
- Cross-Functional Collaboration: Work closely with cross-functional teams, including Program Management, Regulatory, CMC, and Quality, to ensure alignment of activities with study projects and timelines.
- Vendor Management: Manage vendor relationships, including CROs, to ensure performance expectations are met and timelines are adhered to.
- Quality Assurance: Work with Autobahn QA to review CRO Quality Systems and perform audits as required.
- Leadership and Team Management: Provide leadership and guidance to team members, promoting a culture of energy and commitment that challenges people to excel.
- Education: Bachelor's Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study.
- Experience: Minimum of 4 years of relevant and progressive clinical trial management experience, with a proven track record of successful management of global clinical research studies in the biotech industry.
- Skills: Advanced program/project management skills, with experience in software proficiency in Microsoft Office Suite and document sharing sites.
- Attributes: Results-driven, systematic, analytical, and critical thinker, with strong interpersonal skills and ability to function effectively in an organization where infrastructure and processes are still under development.
- Competitive Compensation Package: Including bonus opportunities and stock options.
- Benefits: Medical, Dental & Vision Plans, 401(k) Plan, Unlimited Paid Time Off, 11 paid company holidays, and more.
