Associate Director, Clinical Operations

Job not on LinkedIn

🔥 12 minutes ago

🇺🇸 United States – Remote

💵 $162k - $227k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Plan and execute early-stage clinical trials, initially focused on oncology programs • Interface with internal and external stakeholders to plan, execute, and problem-solve throughout clinical trials • Lead site- and CRO-facing interactions, including study start-up, drug and budget forecasting, and acquisition of high-quality clinical and translational data • Serve as clinical operations program lead for at least one program and associated studies • Lead a team of clinical operations staff • Develop clinical operations strategy for assigned development programs • Collaborate cross-functionally to develop protocols, annual safety reports, investigator brochures, clinical study reports, presentations, regulatory submissions, and publications • Evaluate and select CROs, sites, and other external collaborators; develop vendor scopes of work, contracts, quality plans, monitoring plans, and budgets • Develop and manage SOPs and ensure GCP compliance • Evaluate vendor performance, troubleshoot challenges, and recommend solutions • Develop and manage study timelines with internal partners • Attend and present at study site initiation meetings and study calls as appropriate • Plan and forecast patient recruitment • Manage or mentor Clinical Operations team members

🎯 Requirements

• Minimum 8 years of experience in clinical operations across at least 2 therapeutic areas, including oncology • Experience managing CROs and vendors in the US and international clinical trials • Experience in site initiation visits, site management, and data cuts for publication and regulatory requirements • Understanding of the drug development process from IND to NDA • Ability to communicate effectively and efficiently • Willingness to train other team members within and outside Clinical Operations • Experience in large Pharma and biotech and with biomarker-selected studies preferred but not required • Experience with at least one report preferred, but strong hands-on experience and a growth mindset will be considered

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package