Who we are:

Ashvattha Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel hydroxyl dendrimer therapeutics (HDTs) to treat unmet medical needs in ophthalmology and neurology. We believe that HDTs are the future of targeted, personalized therapeutics.

The Position:
We are seeking someone who enjoys the challenge and has the skills to build and manage a clinical operations department.  The Head of Clinical Operations will contribute to the development, implementation, and strategic direction of multiple clinical studies. We are looking for a seasoned leader who can build and lead a staff and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements. The successful candidate will establish and lead Governance meetings with CROs and other trial vendors and serve as a key escalation point for teams and vendors. The Clinical Operations Leader will contribute their expertise in cross-functional meetings and develop and implement department initiatives in alignment with corporate objectives. This position can be remote or local to our Redwood Shores corporate office. The successful candidate will report to the Chief Medical Officer. 

Professional Responsibilities:

  • Accountable for the execution and oversight of multiple clinical trials
  • Oversight and management of current Phase 2 trials in neovascular AMD and DME (ophthalmology), as well as neuroinflammation imaging (Alzheimer’s, ALS, PD, MS)
  • Responsible for planning and execution of future Phase 1, 2 and 3 trials in the above indications
  • Responsible for the selection and management of Contract Research Organizations (CROs)
  • Attends CRO or other vendor meetings to assure alignment and achievement of study goals
  • Develop, implement, and monitor CRO and vendor budgets and contracts
  • Tracking and reporting of study metrics
  • Identify and mitigate risks to study implementation, enrollment, conduct, compliance and completion
  • Develop and manage effective working relationships with Principal Investigators and other key clinical opinion leaders
  • Provides technical expertise for trial conduct and for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.)
  • Partners with and maintains regular contact with key stakeholders including Regulatory Affairs (RA), , Legal, Finance, and others as necessary
  • Develops risk mitigation strategies with CROs to ensure timely completion of clinical trials and informs senior management of clinical trial status when deviations in scope, budget, or timelines occur
  • Review clinical data and assist in generating study reports and publications
  • Creates Standard Operating Procedures (SOPs) for Clinical Development and Operations (protocol design, vendor selection, etc.)
  • Travel may be required up to 30% in support of clinical study activities
  • Focuses on team work with both internal and external relationships
  • Strong scientific knowledge of key aspects of the clinical program or able to quickly develop necessary knowledge to ensure clinical trial operational success.


Education/Experience:

  • BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
  • This person is expected to have a minimum of 15 years of experience with at least 7 years of leadership experience.
  • Extensive Clinical operations experience in the CRO/pharmaceutical/biotech industry with a proven track record as a leader in clinical trials
  • Previous experience in ophthalmology and/or neurology is a strength.
  • Experience leading programs from Phase I through III preferred
  • Must enjoy playing a hands-on role and have previous experience building and managing a clinical operation department.
  • Experience leading and executing process changes, writing SOPs and other controlled documents.
  • Must be able to work on site at our Redwood City facility, a minimum of 2 days per week.


Compensation

Ashvattha provides a competitive compensation package including 100% employer paid health insurance premiums for employees and their families, along with equity and an annual cash bonus program.  The posted salary range is for employees living in the San Francisco Bay Area.

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