Director of Clinical Operations Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians.
We believe an era of stalled innovation for pain management is over.
From San Francisco to Singapore, our team has a passion for solving medical challenges that could benefit millions.
We pursue our mission with the energy of a dynamic, global team of entrepreneurs, scientists, clinicians, and innovators.Our upbeat culture is one of integrity, curiosity, and appreciation for diversity in thought and background.
Our employees have can-do attitudes and an openness to listen to one another that creates a supportive environment where everyone is aspiring to do their best work.The Director of Clinical Operations is responsible executing the strategic clinical program at Allay Therapeutics and for participating in the development and planning of the strategic program.
This person has the responsibility for the day-to-day management and execution of all clinical studies and must ensure compliant, timely, and high-quality data results from the clinical studies.
This person will serve as a partner with leaders in multiple departments including R& D, Regulatory, Manufacturing and Quality in order to support and execute the company’s clinical research objectives.
The position will report to the VP of Clinical Operations.Other responsibilities include:Develop and drive key strategic partner relationships to ensure study execution is done in compliance with GCP, in an efficient and effective manner, within timelines, and on budget.Responsible for obtaining and optimizing use of resources to ensure project success, ensuring that all procedures comply with relevant regulations, guidance, directives, and standards.Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met.Oversight of designated activities outsourced to CROs, external consultants, central and core labs and other vendors.Develops, reviews or participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports, investigational product labeling/kitting, Pharmacy Manuals, EC/IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DSMB charter, close-out plans, and other documents as needed or requested.Responsible for participating in the development of, and the oversight for, clinical study milestones to support program and company objectives.Develop or oversee study-specific monitoring plans and ensure appropriate quality and timely monitoring of clinical sites.
Identify any gaps in compliance and performs site monitoring with the field team if required.Perform other related duties as assigned by management.Oversee execution of all operational aspects of one or more clinical studies, including identification and management of vendors and sites, availability of clinical and non-clinical supplies at the sites, subject enrollment, and data entry and cleanlinessOversees start-up and close-out activities at clinical sites and with vendors.Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, applicable regulations, guidance documents, and the study protocolProactively monitor and report trial progress and performance to ensure transparency across all internal and external (vendor) teams, including timelines, the current status of study milestones, work to date and any necessary budgetary requirementsRaises any identified gaps in company SOPs and support the development of internal SOPs as neededQualificationsExperience and Education Requirements:Bachelor’s or advanced degree in a Scientific discipline with 10 or more years of industry experience in the medical device or pharmaceutical industry.Strong organizational, communication, and interpersonal skills with ability to work effectively in a team setting.Ability to negotiate effectively and to influence upper management and strategic partners to ensure that business goals are met.Excellent understanding of the concept and application of Good Clinical Practices.Strong working knowledge of statistical methods used in analyzing clinical hypotheses.Demonstrated strong track record of leadership, collaboration and people development.Experience with clinical protocol design, clinical trial operations, and clinical trial logisticsDemonstrated ability to think strategically and creatively while contributing to multiple projects.Thrives in a highly collaborative, multi-disciplinary team setting.Ability to train, supervise and mentor junior staff.Must be able to communicate at all levels within the organization.Experience operating effectively within a biotech start-up; the ability to prioritize tasks and manage multiple priorities, meet deadlines, and be flexible to changing priorities is critical.Experience with post-operative pain studies and/or orthopedic indications preferred.Ability to travel domestically and internationally up to 30% of the time as needed to meet company objectives.