Job Description


Senior Clinical Trial Manager / Associate Director, Clinical Operations

Position Summary

Antiva Biosciences, a growing first-in-class women’s health and virology company based in the San Francisco Bay area and focused on empowering patients globally with the first ever at-home treatment for HPV related diseases to prevent cancer, is seeking a Senior Clinical Trial Manager / Associate Director, Clinical Operations (level based on candidate’s experience). This position will play a key role on Antiva’s Clinical Operations team and be responsible for the implementation of clinical trial activities across one or multiple studies across our development programs. Working closely with investigative site personnel and CROs, this role will drive the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.

As a member of our team, you’ll work closely with internal team members and external partners as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets.

The ideal candidate has proven clinical trials experience within the biotech or related industries preferably with virology and/or infectious disease early development experience, especially management of one or more concurrent studies. To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical operations skills and a proactive attitude that fits our culture. The position will be based in our San Francisco Bay area office with a hybrid working model.

Specific Responsibilities Include (but not limited to):

  • Study leadership of hybrid outsourced global multi center studies operating with a high degree of accountability and a strong sense of urgency.
  • Line management, performance management and mentorship of study team members (CRA, CTA) ensuring clear communication of expectations and responsibilities.
  • Study budget management, vendor performance management and ensuring appropriate levels of escalation.
  • Study Management Team leadership, ensuring a high degree of accountability from self and others and ability to effectively lead productive meetings.
  • Able to develop and review granular study timelines and able to pressure test timelines with third parties.
  • Able to review and negotiate all study budgets ensuring favorable terms for Antiva.
  • Able to operationally review contracts and able to make thoughtful recommendations internally.
  • Strong ability to prioritize tasks, delegate with appropriate direction and multi task in a fast paced environment.
  • Able to create, review and implement fit for purpose study plans.
  • Participating in the development, review and implementation of departmental SOPs and processes.
  • Recommending and implementing innovative process ideas to positively impact clinical trials management as well as proactively identifying potential study issues/risks and recommending/implementing solutions to the Project Team.
  • Maintaining operational tracking and reports in support of program and/or departmental activities (e.g., Decision Log, Monitoring Visit Report Review Log, Clinical Operations Agreement Tracker, SOP Tracker, etc.).
  • Interacts with the study Medical Director and members of the cross-functional study team, as needed; interacts frequently with cross-functional internal and external personnel (eg, Regulatory Affairs, investigators, vendors).
  • Coordinating and assisting in the planning of regulatory or ethics committee activities, as appropriate.
  • Direct management and/or mentoring of junior Clinical Operations team members.
  • Performs other tasks assigned to promote the efficient management/oversight of the clinical trial(s).

CRO/Vendor Management Activities Including:

  • Participating in and facilitating the CRO/vendor selection process for outsourced activities.
  • Managing CRO interactions including sponsor oversight of operational functional activities (study management, monitoring, site management, trial master files and documentation).
  • Working with the CRO to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met.
  • Preparing, reviewing, and approving study-related documents (e.g., Monitoring Plan, Laboratory Manual, Study Reference Manual, Pharmacy Manual and CRF Completion Guidelines).
  • Participating in the selection, training, and evaluation of clinical sites.
  • Serving as a liaison and resource for CROs, vendors and investigational sites.
  • Preparing, reviewing, approving site study documents and templates, (informed consent template and study tools/worksheets), investigator contracts, and site payments.
  • Participating in site monitoring or monitoring oversight visits, as appropriate.
  • Supporting quality assurance activities by coordinating resolution of audit findings and Corrective and Preventative Action Plans (CAPAs); ensuring audit-ready condition of clinical trial documentation including the TMF; reviewing monitoring visit reports to ensure quality and resolution of site-related issues.

Requirements:

  • Bachelor’s Degree with 7+ years of clinical research experience; virology/infectious disease and/or women’s health experience a plus.
  • Knowledge of ICH GCP guidelines and regulatory requirements for clinical trial management; strong clinical study management skills.
  • Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
  • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met.
  • Inspection readiness experience is preferred but not required.
  • Excellent communication skills to effectively disseminate information to project team and outside parties.
  • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Excellent organizational, conflict resolution, prioritization and negotiation skills.  Proven ability in creative problem-solving and exercising sound judgment.
  • Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners.
  • Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment.
  • Ability to handle a high volume of highly complex tasks within a given timeline.
  • Ability to develop therapeutic area knowledge and expertise through internal training and external conference attendance.
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook; strong knowledge of MS Project for management of trial timelines.
  • Candidates local to San Francisco Bay area who are able to work part-time in the Antiva office preferred; remote candidates should be willing to come to SF Bay Area for in-office work approximately 1 week per quarter as needed; additional travel may be required (e.g., Investigator Meetings, site visits, etc).

Antiva offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic, collaborative and science driven environment. Exact compensation for this role may vary based on skills, experience, and location.  General pay range for this role is $175,000 - $200,000.


How to Apply

To apply, please mail or email your CV and cover letter to:

Antiva BioSciences, Inc.
Attn: Human Resources
555 Twin Dolphin Drive, Suite 620
Redwood City, CA 94065
Email:

Antiva is an equal opportunity employer.