Apogee Therapeutics
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
Associate Director - Clinical Operations
2 days ago
🏡 Remote – Anywhere in California
Apogee Therapeutics
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
Description
• We are seeking an Associate Director, Clinical Operations accountable for operational management of clinical trial programs (Phases I-III). • Responsible for ensuring adherence to GCPs, SOPs, and regulatory agency guidelines, study operational planning and execution. • Oversight of and partnership with CROs and vendors to ensure study milestones and deliverables are achieved. • Routine interaction with key internal and external stakeholders, communicating project status and troubleshooting inquiries.
Requirements
• BA/BS in life sciences or equivalent • 8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion • 2+ years’ experience in Biotech industry strongly preferred • Phase 1 experience strongly preferred • Significant knowledge of pharmaceutical industry, drug development and regulatory processes • Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets • Emerging leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety • Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly • Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets • High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines • Work comfortably in a fast-paced, dynamic work environment and embrace change • Ability and willingness to travel up to 15%
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
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