Director, Clinical Operations

BACKGROUND

Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd. (Zydus), is a commercial stage biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases. With an emphasis on commercialization, Sentynl looks to acquire, develop and commercialize well-differentiated products across a broad spectrum of therapeutic areas to address a variety of genetic orphan and neurological disorders.

SUMMARY

The Director of Clinical Operations will provide strategic and operational leadership in the planning, execution, and oversight of clinical study programs across the full development lifecycle (Phase 2/3 through Phase 4). This role is accountable for the successful delivery of studies within the Clinical Development Plan whether conducted in-house or outsourced to third-party vendors. Working cross-functionally with internal stakeholders and external partners, the Director, Clinical Operations will manage timelines, budgets, and resources while ensuring regulatory compliance and operational excellence.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Lead the end-to-end operational execution of clinical trials, including planning, site selection, study initiation, enrollment, monitoring, and close-out activities.
  • Oversee the development and management of study budgets, timelines, and resource plans; ensure timely and accurate forecasting, accrual tracking, and invoice approval.
  • Translate product development goals into operational strategies and actionable study plans in collaboration with Medical Affairs and cross-functional teams.
  • Manage vendor oversight and performance using key metrics and tools; oversee contract and budget negotiations with vendors and clinical sites.
  • Ensure compliance with GCP, ICH, and FDA regulations throughout study conduct; proactively identify risks and implement corrective actions.
  • Coordinate cross-functional collaboration between clinical operations and internal departments and/or external resources such as data management, biostatistics, safety, regulatory affairs, QA, and medical writing.
  • Support clinical monitoring and site management activities; serve as clinical coordinator for drug shipment management and requests in collaboration with cross-functional partners.
  • Oversee the development and review of study-related documentation, including protocols, informed consent forms, operational manuals, and communication plans.
  • Provide strategic input for clinical program planning and feasibility assessments, support inspection readiness and audit preparation efforts.
  • Contribute to the development of clinical reports, investigator brochures, and publications.

KNOWLEDGE/SKILLS/ABILITIES

  • Strong understanding of clinical research regulations and guidelines (GCP, ICH, FDA).
  • Excellent project management, communication, and problem-solving skills.
  • Comfortable working across multiple projects and functional areas with minimal supervision.
  • Proficient in clinical trial systems and software.
  • Highly motivated and capable of providing leadership to internal teams and external partners.

EDUCATION/EXPERIENCE

  • PharmD preferably, or Master’s degree in a scientific or health-related field.
  • 8–10+ years of progressive experience in clinical trial management within the biopharmaceutical industry.
  • Proven track record of managing clinical trials both in-house and via outsourced models.
  • Demonstrated ability to meet clinical operations milestones while shaping strategic direction.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an individual would experience while performing the essential functions of this job.

  • Work location: Solana Beach, CA.
  • Normal office conditions.
  • Ability to travel up to 30%.

CORE VALUES & COMPETENCIES

Growth

  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation

Accountability

  • Results Oriented
  • Ensures Accountability
  • Decision Quality

Transparency

  • Courage
  • Collaboration
  • Instills Trust

Ethics

  • Compliant
  • Unwavering commitment to doing what is right
  • Seeks guidance when unsure

 

Sentynl Therapeutics, Inc. offers a competitive salary program and an attractive benefits package that includes:

  • The base salary for the Director of Clinical Operations will be $160k to $215k.
  • Medical/Dental/Vision Insurance
  • Company paid Life Insurance, Short-term Disability and Long-term Disability
  • 401(k) plan with a generous employer match
  • Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
  • Paid Holidays

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