Associate Director, Clinical Operations Study Lead (COSL)

Requirements

• Bachelor's degree in life sciences or related field
• 7+ years' experience in clinical operations within the pharmaceutical, biotech and or CRO setting including at least 2 years in a study or team leadership role in a pharma or biotech company.
• Experience supporting both early and late-stage clinical studies. Preference for experience with BLA-enabling trials.
• Demonstrated success managing complex clinical studies in global settings; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in neurology and/or ophthalmology preferred.
• Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).
• Strong vendor management skills and experience with complex outsourcing and partnership models
• Proven financial acumen. Experience managing within a study budget, managing and reporting on change order status
• Exceptional verbal and written communication and stakeholder management skills . Track record of developing and delivering high quality materials and updates for leadership forums.
• Demonstrated ability to effectively collaborate with internal and external stakeholders in a highly matrixed setting
• Ability to thrive in a fast-paced, matrixed, and innovative environment.
• Salary Range: $ 170,000 - $200,000

Additional Information

Who is BlueRock? BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. BlueRock Therapeutics Company Culture Highlights Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023 Winner of Comparably's Award for Best Company for Diversity 2022 Winner of Comparably's Award for Best Company for Women 2022 Winner of Comparably's Award for Best CEO 2022 BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably. Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/ Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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