Director, Clinical Development Operations

16 hours ago


Reston, Virginia, United States Autobahn Therapeutics, Inc. Full time
Job Summary

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.
Requirements
  • 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.
What We Offer
  • 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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