Senior Manager Clinical Operations

2 days ago

San Diego, California, United States Autobahn Therapeutics, Inc. Full time
About Autobahn Therapeutics, Inc.

Autobahn Therapeutics, Inc. is a biotech company focused on developing innovative therapies for CNS disorders. Our mission is to improve the lives of people affected by these conditions.

Job Title: Senior Manager Clinical Operations

We are seeking a highly experienced Senior Manager Clinical Operations to join our team. This role will be responsible for overseeing clinical pharmacology studies, including BE, DDI, Mass Balance, and SAD/MAD studies.

Key Responsibilities:
  • Provide sponsor oversight of clinical study conduct, ensuring compliance with Autobahn SOPs, HREC/FDA/EMA/ and other RA regulations, ICH/GCP guidelines, and applicable local laws.
  • Coordinate cross-functional efforts to achieve study objectives, with a focus on quality.
  • Oversee data discrepancy management, assist with mapping, and review risk management plans, protocol deviations lists, ongoing data cleaning, listing review, and TLFs (when available).
  • Inform leadership on overall clinical trial progress, recruitment status, and potential risks, with a focus on creating mitigation plans.
  • Oversee TMF set-up, ongoing quality review, and final reconciliation.
  • Manage vendor relationships, including selection, execution of contracts, and timelines, to achieve project goals and ensure performance expectations are met.
  • Work with Autobahn QA to review CRO Quality Systems and perform audits as required.
  • Encourage others to consider new approaches and ideas, model positive team behaviors, and promote a culture of energy and commitment.
Qualifications:
  • Bachelor's Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study.
  • 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 small company biotech industry.
  • Demonstrated expertise in Phase 1, clinical pharmacology studies in Healthy Volunteers, with experience in Phase 2 and 3 trial oversight desirable.
  • CNS experience is highly desired, with experience beyond oncology and rare disease required.
  • Deep knowledge of FDA and EMA drug development and clinical trial regulations (21 CFR Parts 11, 50, 54, 56, 312, and ICH/GCP/GDPR).
  • Experience selecting, qualifying, and overseeing CROs/vendors/consultants, with experience and knowledge of FDA/EMA IND/NDA submission and approval process.
  • Advanced program/project management skills, with ability to provide flexible and scalable operational solutions to aid effective planning and implementation of programs/trials.
  • Software proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, MS Project, Teams) and document sharing sites (e.g., SharePoint).
  • Experience with electronic quality, compliance, EDMS, and CTMS systems.
Benefits:
  • 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.

We are an equal opportunity employer and welcome applications from diverse candidates. Please apply via LinkedIn or submit your resume and cover letter to [reference CLINPHASE1 in the subject line].

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