Associate Director - Clinical Operations, Autoimmune

February 14

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

+4 more states

🏄 California – Remote 🐊 Florida – Remote 🏖️ New Jersey – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote

💵 $180k - $240k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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RemeGen Biosciences

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RemeGen Biosciences is creating innovative medicines to serve patients suffering from serious illnesses. The company is committed to the discovery and development of innovative and differentiated therapeutics, striving to create value through delivering medicines for the treatment of diseases with unmet medical needs.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Managing CRO and other external vendors • Collaborating with cross-functional teams • Ensuring study strategy is incorporated into the execution of each study • Executing studies on-time, on-budget and in compliance with FDA, EMA & ICH guidelines • Proactively managing trial start up activities in collaboration with CRO • Participating in the CRO selection process and negotiate master service agreements • Identifying clinical trial operational risks and developing mitigation strategies • Planning and implementing quality checks for multiple clinical trials • Providing clinical operational input to protocol, ICF, safety and other relevant clinical trial key documents • Driving development of work instructions and SOPs • Supporting the manager to lead clinical operation activities • Preparing clinical trial documents • Effectively communicating regular clinical trial updates to management • All other duties as assigned.

🎯 Requirements

• Education: Bachelor of Science or equivalent degree, required. • Master of Science/Advanced degree preferred. • Experience: 10+ years of increasing leadership responsibilities in clinical operations in a pharmaceutical, biotech or CRO company. • In-depth knowledge of clinical operations and pharmaceutical drug development process in a pharmaceutical or biotech company in the Autoimmune Therapeutic area, preferred. • Proven ability to lead a team, supervise CRO, and collaborate with cross-functional teams to deliver global clinical trials with high quality, within budget and on-time. • Thorough understanding of FDA, EMA, and HIPPAA clinical research regulatory requirements, good clinical practices, project management and data handling. • Skills: Excellent written and verbal communication skills. • Ability to work cross-functionally in a fast-paced, collaborative environment. • Strong attention to detail and problem-solving skills.

🏖️ Benefits

• 401(k) and matching program • Medical, Vision, and Dental Insurance • Flexible Spending Account • Short- and long-term disability • Life insurance • Employee Assistance Program • Employee discounts • Paid time off/vacation/sick time • Professional development assistance • Referral program