Associate Director, Toxicology Operations
About The Position
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 Parkinsonâs 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. 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 patientsâ lives. It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patientsâ lives across multiple disease areas. The Associate Director, Toxicology Operations will be expected to take on a highly visible role with internal and external stakeholders through the management of nonclinical study plans in support of BlueRockâs pipeline. The Program Toxicologist will leverage their expertise in toxicology to advance the companyâs development pipeline by working closely with program leads and other subject matter experts. The position will be based in Cambridge, Massachusetts with a hybrid expectation (3 Days/Week in Office).
Requirements
- BS or MS in relevant field
- Minimum of 6 years toxicology operations experience in industry
- Must have direct experience partnering with CROs to deliver nonclinical studies (e.g., biodistribution, tumorigenicity, local tolerability)
- Ability to travel
Nice To Haves
- Knowledge of cell therapy space preferred
Responsibilities
- Support Program Toxicologists in the design of nonclinical studies
- Lead Nonclinical Study Team(s) for multiple studies and assets
- Lead nonclinical study start-up, execution, and timely reporting of results and ensure organizational awareness around study progress
- Partner with CRO to plan and manage study timelines
- Act as the internal lead to ensure smooth transfer of study materials to CRO in support of study plans
- Partner with Research, CMC, Device, and other cross-functional teams to ensure awareness around study timelines, upcoming milestones, and study reporting
- Manage all associated tasks in the planning, initiation, monitoring, and compliance of nonclinical studies
- Develop a relationship with key leaders at CRO, including Study Directors and Business Development
- Travel regularly to CRO to oversee study execution
- Travel to audit CROs/labs as needed
- Ensure raw data and study reports are archived appropriately
- Ensure clinical and nonclinical samples are archived appropriately
- Collaborate within TMND to ensure broad awareness around nonclinical strategy and input into forward looking plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
