Vice President - Clinical Trial Excellence

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Apogee Therapeutics

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Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• The Vice President, Clinical Trial Excellence is a strategic leader responsible for the design, oversight, and execution of clinical trial processes that enhance efficiency, innovation, and operational excellence across the Apogee portfolio. • In this role you will be a key leader on the Clinical Operations Leadership Team (COLT), helping COLT shape the Clinical Operations strategy, and ensuring their vision for excellence is effectively communicated and implemented. • This position will oversee the following functions TMF, Clinical Compliance, Monitoring, and Clinical Business Operations. • Leading the Apogee Clinical Trial Excellence team, overseeing strategic outsourcing and alliance management, financial planning and tracking, TMF management, Apogee process development, inspection readiness initiatives and developing and managing an oversight monitoring (clinical research associate) program. • Hiring, leading and managing people across the Trial Excellence team. • Clearly communicating Trial Excellence initiatives to cross-functional teams. • Represent the Trial Excellence team when communicating with company leadership. • Works with Trial Excellence team to set measurable goals and establish plans to meet the goals. • Communicate a clear vision for the team, emphasizing optimization and excellence in all aspects of trial operations. • Summation of multi-faceted and complex information into clear, concise, executive summary format and perform detailed/well-thought-out business case analyses. • Lead and provide the framework to harmonize operational conduct across the Apogee portfolio in compliance with global regulations and requirements. • Oversee alliance management, cultivating robust relationships with Strategic partners (CROs, large vendors that cover multiple programs, and other external partners, managing contracts and outsourcing effectively to expedite the completion of Apogee clinical trials. • Oversee Clinical Operations Financials (accruals and quarterly forecasting), work closely with Clinical Business Operations and Finance. • Establish and oversee an in-house monitoring sub-group to support monitoring and site oversight. • Technology Integration: evaluate and implement technology solutions to streamline clinical workflows, enhance data capabilities, and improve operational efficiency. • Keep current on emerging technologies and trends in healthcare informatics. • Talent development: recruit, develop, and retain top talent within the team, fostering a culture of excellence, collaboration, and professional growth. • Provide mentorship, coaching, and training to team members to enhance their capabilities and drive performance improvement. • Lead development of trial diversity, equity, and inclusion vendors, data sources and platforms to support the enrollment of diverse patient populations across the clinical trials. • Drive collaborative efforts across the organization, building and maintaining strong partnerships with peers and key stakeholders. • Guide the clinical operations leadership team through the ambiguity of rapid growth, system build, and change management, focusing on building new capabilities and scaling operations as needed.

Requirements

• Minimum 20 years of pharmaceutical/biotech industry experience in Clinical Operations • Bachelors degree required. Advanced degree in life sciences, healthcare, or related field (MSc, MBA, PhD, or equivalent) strongly preferred. • Minimum 10 years of team leadership experience, with a proven track record of building effective teams and driving innovation in clinical trial optimization • Ability to gather/analyze multifaceted data and distill into an executive summary with strong concise supporting business analysis • Deep understanding of the clinical trial landscape and commitment to innovation, creativity, and operational excellence • Experience and skillset selecting and managing CROs, vendors and/or clinical trial consultants • Strong leadership and interpersonal skills, with the ability to inspire and motivate teams, build consensus, make decisions, and influence stakeholders at all levels of the organization • Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations • Strong project management skills, effective matrix leadership, and the ability to hold teams accountable for deliverables • Ability and thrive in a highly entrepreneurial biotech environment • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Availability to participate in calls across multiple international time zones • Position requires 25 – 30% travel

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • Flexible PTO • Two, one-week company-wide shutdowns each year • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve