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Form of workWho is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
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.
This position will lead a cross-functional clinical development team to ensure the successful planning, execution, and close-out of an upcoming Phase 1/2a clinical study and other studies, as needed. This individual will manage and oversee internal and external study activities, managing and overseeing a CRO and other vendors. The position will be a member of the Clinical Operations group, reporting to the Director, Clinical Operations.
Responsibilities:
- Perform day to day management and oversight of assigned Clinical Trial to ensure deliverables are met timely and within budget
- Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Develop and maintain study level timelines and budget with internal leadership and CRO
- Work with CRO to provide monthly metrics report to track against timelines (i.e. study dashboard report)
- Responsible for ongoing study communication and escalation of study-related issues as required
- Develop and adhere to vendor oversight plans
- Contribute to or author relevant study documents such as the protocol, informed consent form, investigator brochure, clinical study reports and other documents and plans, as appropriate
- Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)).
- Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews
- Oversight and review of data management outputs
- Responsible for protocol deviation review and listing
- Participate in and provide feedback during RFI, RFP and bid defense process for new studies
- Participate and review quality plans and audit reports for the study and provide oversight of CAPA resolution with the CRO, vendors and sites, as needed
- Oversee any subcontracted vendors through CRO
- Review and track monitoring report issues, GCP compliance concerns and monitor performance; oversight of timely issue resolution at sites; Perform and/or coordinate sponsor oversight visits at the clinical sites to ensure quality of monitoring and sites adherence to GCP
- Oversight of the eTMF for the trial and will ensure an audit/inspection ready Participate and review SOPs for clinical operations and other functional areas as needed
- Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
- Support during relevant inspections (e.g., FDA)
- Assist CRO with planning of Investigator Meetings and associated travel
- Facilitate review of Clinical Trial agreements
- Identifies potential risks form study and works with the team to resolve any issues
- Participates in UATs, e.g., EDC, IRT
- Mentoring assigned Clinical Trial Coordinator
Minimum Requirements:
- Bachelor's degree in the Life Sciences or equivalent is required
- 8 years of experience in clinical operations is required
- Ability to build strong relationships with the sites and CRO including providing feedback as well as oversight
- Passion for working in a small company environment - including being self-motivated and proactive
- Ability to think of big picture as well as being adept at detail-orientation
- Up to 20% travel may be required
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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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