Associate Director, Global Clinical Operations - Early Development

April 26

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 an Associate Director, Global Clinical Development Operations (AD, GCDO), who will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). 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. The AD, GCO will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. This role will report to the Executive/Sr. Director, Clinical Operations.

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% • Experience working of Phase 1 trials (i.e. FIH, Clin Pharma, SAD/MAD design, etc.) • Building relationships with Phase 1 Clinical Research Units • Experience developing recruitment strategies to support Phase 1 units

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