Director, Clinical Development Operations
16 hours ago
We are seeking a highly experienced Senior Director, Clinical Operations to join our team at Autobahn Therapeutics, Inc. as a key member of our executive team. The successful candidate will be responsible for leading and overseeing operational resources related to CNS-driven drug development programs, including managing direct reports and vendors.
Key Responsibilities- Leadership and Strategy
- Develop and implement clinical operations strategy to ensure efficient planning, execution, and delivery of clinical trials according to required standards and regulations.
- Build and lead a high-performing team of clinical operations professionals.
- Operational Management
- Manage and oversee operational resources, including direct reports, vendors, and contractors.
- Develop and maintain SOPs, protocols, and other operational documents.
- Regulatory Compliance
- Ensure compliance with ICH/21CFR/EMA clinical trials regulations and other relevant regulations.
- Collaborate with regulatory agencies to support filing/application activities, review, and approval process.
- Project Management
- Plan, oversee, and report on clinical trials, ensuring timely and high-quality delivery.
- Evaluate the health and success of program/project deliverables, making adjustments as necessary.
- Communication and Collaboration
- Proactively collaborate with stakeholders to communicate information effectively.
- Prepare and present updates and reports, as required.
- Education
- Bachelor's degree is required.
- Master's degree or higher degree is welcome.
- Experience
- 10+ years of US clinical operations/project management experience in the biopharmaceutical industry is required.
- CNS and/or rare disease experience is required. Psychiatry experience is highly desired.
- Deep knowledge of drug development, ICH/21CFR/EMA clinical trials regulations, and clinical operations roles and responsibilities is required.
- Previous line management and hiring experience.
- Experience selecting, qualifying, and overseeing CROs/vendors/consultants.
- Experience and knowledge of FDA/EMA IND/NDA submission and approval process.
- Attributes
- Transparency, humility, accountability, collaborative, inclusive leadership, high level of EI/adaptability/resilience.
- Ability to function effectively in an organization where there is very little infrastructure in place.
- Critical thinking - Asks the right questions at the right time and understands how RBQM can be applied within early development.
- Knows what regulatory changes are coming and can keep up to date/assess impact on wider organization.
- Competitive compensation package including bonus opportunities and stock options.
- Medical, Dental & Vision Plans.
- 401(k) Plan, including company match with immediate vesting.
- Unlimited Paid Time Off.
- 11 paid company holidays.
- Autobahn Perks (gym membership, discounts to Alexandria restaurants, free lunch twice weekly, company-sponsored events, etc.).
- Flexible spending account for medical and dependent care.
- Life insurance, short and long term disability plans.
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