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Associate Director, Clinical Operations

8+ years
$182,000 to $212,000 annually
10 June 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary

Aligos Therapeutics, a leading clinical-stage biopharmaceutical company in South San Francisco, seeks an experienced Associate Director, Clinical Operations to drive the operational execution of early-stage clinical trials. The role involves overseeing multiple investigational drug programs targeting liver and viral diseases, including MASH, COVID-19, and chronic hepatitis B. The ideal candidate will bring strong clinical trial management expertise, vendor oversight skills, and a thorough understanding of GCP and regulatory requirements to ensure trial success from planning to reporting.


Key Responsibilities

  • Develop and implement realistic, high-quality, cross-functional clinical trial plans.

  • Select and manage Service Providers (SPs) and investigational clinical sites.

  • Oversee drafting of key study documents: protocols, CRFs, ICFs, monitoring plans, and investigator brochures.

  • Maintain study timelines, budgets, and deliverables from start-up to close-out.

  • Lead training, oversight, and communication with SPs and trial sites.

  • Conduct quality review of (e)TMF and ensure GCP compliance and inspection readiness.

  • Collaborate with CMC on drug forecasting and supply logistics.

  • Prepare and review clinical data listings, interim, and final clinical study reports.

  • Identify trial-level risks and proactively implement mitigation strategies.

  • Contribute to department SOP development and best practice process improvements.

  • Mentor and oversee junior Clinical Operations staff; possible supervisory responsibilities.


Required Skills & Qualifications

  • Bachelor’s or RN degree (minimum).

  • 8+ years of clinical monitoring and clinical operations experience in pharma, biotech, or CRO environments.

  • Strong understanding of FDA, EMA regulations, ICH guidelines, and GCP.

  • Proficient in vendor selection, negotiation, and oversight.

  • Exceptional organizational, problem-solving, and decision-making abilities.

  • Excellent communication and interpersonal skills.

  • Ability to manage multiple priorities in a fast-paced setting.

  • Experience in antiviral or anti-infectious disease clinical development (preferred).

  • Flexibility to adapt to a small, dynamic company environment.


Perks & Benefits

  • Competitive annual salary ranging from $182,000 to $212,000 (excluding bonuses, equity, and benefits).

  • Comprehensive medical, dental, and vision insurance.

  • Life insurance, short- and long-term disability coverage.

  • Health Savings Account (HSA) and Flexible Spending Account (FSA).

  • 401(k) plan with employer contribution.

  • Employee Stock Purchase Plan (ESPP).

  • Generous Paid Time Off (PTO) policy.

  • Opportunities for career advancement in clinical development.


Company Description

Aligos Therapeutics is a science-driven, clinical-stage biopharmaceutical company pioneering treatments for liver and viral diseases such as MASH, COVID-19, and chronic hepatitis B. Leveraging proprietary oligonucleotide and small molecule platforms, Aligos is advancing innovative therapeutics to address significant unmet medical needs globally.


Work Mode

Hybrid (On-site presence required Tuesday to Thursday at South San Francisco headquarters)


Call to Action

Ready to lead innovative clinical trials and transform the future of antiviral therapies? Apply now to join Aligos Therapeutics and make a global impact in the field of biopharmaceutical research.


Salary/Compensation Range: $182,000 – $212,000 annually (excluding bonus, equity, and benefits)