Director, Clinical Operations

April 30

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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

• We are seeking a Director, Global Clinical Operations (Dir, GCO), who will be accountable for the strategic operational management, tactical planning, and execution of global clinical trial programs (Phases I-III). This individual will be a key leader within Clinical Operations, driving the success of their assigned clinical trials and teams. They will lead the collaborative partnership of the cross-functional matrix team. The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections.

Requirements

• BA/BS in life sciences or equivalent • Minimum12 years of clinical research experience, including at least 5 years leading global projects from inception to completion, coupled with demonstrated ability to hold team and CRO members accountable to tight timelines and budgets • Minimum of 4 years line management experience • Experience building a Clinical Operations Department in a growing company • Experience working in a Functional Service Provider (FSP) model • Experience managing a clinical program from Phase 1 to Phase 2 (and eventually into Phase 3) • Leader with growth mindset, willing to learn from as well as mentor others • Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally • Strong communication skills with ability to develop relationships and present to a variety of stakeholders and tailor message accordingly • Able to distill complex matters into a clear business case and roadmap for execution • Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally • Proven ability to effectively execute clinical trials within designated program budgets, timelines and compliance guidelines • Work comfortably in a fast-paced, dynamic work environment • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

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