Associate Director Clinical Operations - Rare Disease

​🌟 Exciting Opportunity: Associate Director of Clinical Operations – Rare Disease Focus 🌟

Are you driven by the opportunity to make a significant impact in the lives of individuals affected by rare diseases? Do you possess a passion for leading clinical research initiatives that have the potential to transform healthcare outcomes for those in need? Join our dedicated team client, a pioneering organization committed to advancing rare disease research through innovative clinical trials.

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Position: Associate Director of Clinical Operations

Location: Remote (ET/CT Preference)

🔍 About Us:

Our client is on a mission to accelerate breakthroughs in rare disease treatment and care. With a focus on driving innovation and collaboration, we're dedicated to bringing new therapies to market that address the unmet needs of patients and families affected by rare diseases worldwide.

💼 Responsibilities:

• Lead and oversee clinical operations for rare disease trials, from study planning and initiation through closeout, ensuring compliance with protocol, regulatory requirements, and quality standards.

• Collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Regulatory Affairs, and external partners, to drive successful trial execution and achieve key milestones.

• Directly manage a team of 3-5 management-level resources.

• Provide strategic guidance and operational expertise to optimize trial design, site selection, patient recruitment, and data management strategies specific to rare disease populations.

• Implement robust risk management strategies and mitigation plans to proactively address potential challenges and ensure trial success.

• Cultivate strong relationships with investigative sites, patient advocacy groups, CROs, and key stakeholders to foster collaboration, patient engagement, and adherence to study protocols.

• Drive continuous process improvement initiatives to enhance operational efficiency, streamline workflows, and maximize resource utilization across rare disease clinical trial activities.

👤 Qualifications:

• Advanced degree in a relevant scientific discipline (e.g., MD, PhD, PharmD) preferred.

• Minimum of 15 years of experience in clinical operations within the pharmaceutical or biotechnology industry, with a focus on rare disease therapeutic areas.

• Minimum of 8 years of independent clinical trial management/project management experience.

• Proven track record of successfully managing rare disease clinical trials across various phases (Phase I-IV), with a deep understanding of rare disease patient populations, challenges, and opportunities.

• Strong leadership skills with the ability to inspire and motivate cross-functional teams to achieve common goals and deliver high-quality results.

• Excellent communication, negotiation, and problem-solving skills, with a collaborative and proactive approach to driving innovation and overcoming challenges.

• Experience working in a fast-paced, dynamic environment with the ability to thrive in a matrixed organizational structure.

🌱 Benefits:

• Competitive compensation package including base salary, performance-based bonuses, and comprehensive benefits.

• Opportunities for professional growth and career advancement within a mission-driven organization committed to rare disease research and innovation.

• Collaborative and inclusive work culture that values diversity, empathy, and teamwork.

• Access to cutting-edge technologies, resources, and opportunities to collaborate with leading experts in rare disease research and patient advocacy.

Join us in our quest to transform the landscape of rare disease treatment and make a meaningful difference in the lives of patients and families worldwide. If you're ready to lead with purpose and drive positive change, we want to hear from you!

To apply, please submit your resume and cover letter outlining your relevant experience and qualifications to robert.giarratani@rbwconsulting.com