Overview

Perceive Biotherapeutics is an exciting clinical-stage company, with a team focused on improving human health by developing breakthrough neuroprotective therapeutics that use novel approaches to treat highly-prevalent, blinding diseases. Perceive Bio brings together an experienced world-class team of leaders, scientists and drug developers. Our unique approaches are first-in-class and best-in-class gene therapy and small molecule therapeutics that will significantly impact patient’s lives.

We are looking for a talented and experienced individual to join our growing team to lead Clinical Operations and contribute to the company’s long-term goals and success. The successful candidate will be diversely experienced, thoughtful, collaborative, highly motivated & productive, and possess the desire to learn, improve processes, support key clinical stakeholders during our Ph 1 and Ph 2 trials with an emphasis towards quality, efficiency and operational best practices. This individual will be part of a highly collaborative and productive team and receive mentorship for professional growth and leadership.

Responsibilities

Context and Job Duties/Responsibilities:

The program is being executed in partnership with well-established Ophthalmology Contract Research Organizations and several other service providers. The ability to thoughtfully plan for, select, manage and collaborate with such entities is a core competency that can determine success or failure of clinical trial activities and indeed, the company.

This role is intended to oversee all aspects of clinical operations for the company and will collaborate closely with the Executive Team (CMO, President, CEO and CFO) on the execution of critical functions. This leader will be responsible for architecting and advancing the Clinical Operations plan including overall strategy and budget, additional site and CRO selection, trial vendor oversight for timely and quality trial conduct, ensuring successful relationships with service providers and clinical trial sites, keeping management apprised of clinical progress, and building core expertise for the company in clinical operations.

This individual will set the standards for clinical operations performance and advance the culture of collaboration required for success. A successful candidate in this role will quickly determine and address the following needs:

• Clinical trial activities: Structure, resource and budget planning across Phase 1 and 2 trials, anticipation, and coordination of activities for key events in clinical trials globally. Oversight and close collaboration with CROs for site selection and onboarding, site management and achievement of enrollment targets, data and conduct quality, and overall compliance with protocol and regulations for inspection readiness. Ensure full alignment with all business areas such as quality and drug supply to enhance synergies and avoid duplication of efforts. This program will have multiple, simultaneous early-stage clinical trials so ability to work efficiently with attention to detail and planning is paramount.
• Clinical Operations Functional Excellence: Recommend which activities should be performed internally and how; which should be performed externally and what is the best approach; how do we assure and measure high quality of performance
• Clinical Operations Execution: ensuring safe, efficient and rapid trial enrollment and collection of high-quality clinical data
• Trial Vendor Oversight and Management: Determine the best approach to sourcing and managing vendors to perform given the operating model that includes heavy reliance on third parties in an evolving field. Both tactical and strategic elements required:
  • Ensure best fit providers are selected according to acceptable guidelines and quality standards
  • Ensure creation of onboarding plans to and supports any required transition plans to ensure effective transition to/from vendors with minimal risk to business operations
  • Establish reasonable service levels and performance targets
  • Ensure roles and responsibilities with vendors and partners are clear in contracts/agreements so that standards and performance are maintained. Directly or indirectly participates in day-to-day management activities.

• Develop and ensure appropriate level of governance/oversight are in place
• Ensure success of all service provider and collaborator relationships

• Financial Performance: Manage clinical spend to budgets. Clinical trials / spend is the largest budget item and therefore this role plays a critical role in setting and achieving budget targets
• Organizational Strategy, Resourcing & Leadership: Determine internal capabilities and roles needed to execute on high quality clinical trials and think creatively about how to meet resource needs; Proactively identify, justify, and communicate resourcing needs to team along with an actionable plan for meeting any identified needs; Determine the best approaches to attract, develop and retain top clinical operations talent; Partner with Executive Team for Clinical program development strategies.
• Management of key internal stakeholder relationships: Strong familiarity with all key internal stakeholders. Ensures that stakeholder requirements and input are gathered, incorporated and met as appropriate, or informed as to why requirements cannot be accommodated. Constructive information flow and engagement between Exec Team, Clin Ops and PIs/sites.

Qualifications

Capabilities & Knowledge:

• High personal integrity and strong work ethic. Can-do attitude and willingness to work autonomously. Ability to operate with substantial latitude in a fast-paced environment.
• Leadership and Team Management: Proven leader experienced with aligning teams to vision & goals, milestone setting and tracking.
• Clinical Operations acumen: Demonstrated ability to lead clinical projects to timelines and on budget, including detailed tracking, troubleshooting, and effective escalation.
• Business acumen: Strategic planning and continuous improvement knowledge and experience. Influencing/Persuasion/Negotiation/ Decision making skills
• Proven ability to interact well in a multifunctional team setting: Ensure full alignment with all business areas such as quality, finance, and manufacturing to enhance synergies and avoid duplication of efforts.
• Critical thinking, productivity attention to detail, effective communication & collaboration: Demonstrated ability to think critically, identify and solve problems in a multifunctional team setting, and contribute with document creation (ppt, word, excel, SmartSheets). Highly productive performer with attention to detail and the ability to meet deadlines and align stakeholders around key goals/results. Strong interpersonal skills and ability to work and communicate effectively at all levels within and external to the organization required. Strong written and oral communicator who is experienced in preparing and presenting effective presentations internally and externally to challenging audiences preferred.
• External Partner experience: Demonstrated success in working with outside organizations/groups/vendors/CROs. Strong project management skills.

Education& Experience:

A successful candidate for this role is expert in all aspects of pharmaceutical clinical research and the requirements of a clinical operations function. Thoroughly understands early, mid and late-stage trial performance, forecasting, staffing, and business operations.

• 4-year College Degree required
• Advanced degree such as master’s degree or PhD preferred

• Experience with ophthalmology and / or gene therapy preferred

• At least 8 years of experience in the pharmaceutical / biotech / medical device industries with at least 6 years in clinical operations preferred
• Demonstrated expertise in Good Clinical Practices and Clinical Operations principles and practices, including vendor selection, site selection, relevant clinical trial software, compliance, metrics, etc.
• Vaccinated or willing to be vaccinated to meet requirements of entering clinical facilities, including vaccination for Covid-19 per CDC guidelines.

Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

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