Full-Time
Associate Director of Imaging
Ophthalmology, Translational Medicine
BlueRock Therapeutics
201-500 employees
Develops advanced cellular therapies for diseases
No salary listed
Senior
Cambridge, MA, USA
Hybrid
Hybrid position; specific number of in-office days not mentioned.
- Ph.D. in an imaging related discipline with at least 4+ years of industry experience and recognition as a contributor in the field of preclinical and clinical imaging science.
- Ophthalmology imaging experience required.
- Must have direct experience managing clinical imaging protocols in the conduct of clinical trials (endpoints, inter-site harmonization, imaging core lab oversight, etc.).
- Specific experience with imaging endpoints as decision-making in ophthalmic disease required.
- Act as an internal clinical imaging expert in OCT, FAF, and FA techniques.
- Partner with the Translational Leads and Clinical Development teams to lead the use of clinical imaging endpoints across all phases of drug development.
- Propose and execute imaging biomarker validation studies to enable the use of imaging endpoints as decision-making.
- Oversee CRO vendor/partners ensuring that they optimally execute clinical and preclinical imaging projects in the US, Europe and other geographies as needed.
- Ensure timely execution of imaging trials, including providing adequate operational support.
- Oversee and execute image analysis as appropriate and ensure readouts are aligned with the clinical study teams.
- Collaborate with the Research teams to lead preclinical imaging studies and ensure translational relevance of selected readouts.
- Provide support to the Business Development organization.
- Established network of key opinion leaders (KOLs) and external experts in ophthalmology preferred.
- Subject matter expertise in MRI, PET, and SPECT preferred.
BlueRock Therapeutics develops cellular therapies using a unique gene platform to create medicines for neurology, cardiology, and immunology. Their technology allows for the genetic engineering of cells to treat complex diseases like neurodegenerative disorders and heart failure. Unlike competitors, BlueRock focuses on strategic partnerships and research to advance their therapies, generating revenue through collaborations and licensing agreements. The company's goal is to lead in the development of innovative cellular treatments for significant health challenges.
Company Size
201-500
Company Stage
Acquired
Total Funding
$1.2B
Headquarters
Cambridge, Massachusetts
Founded
2016
Simplify's Take
What believers are saying
- FDA RMAT designation for bemdaneprocel boosts credibility in Parkinson's disease treatment.
- Positive Phase I results for bemdaneprocel attract investment and partnership opportunities.
- Collaboration with bit.bio accelerates entry into autoimmune and inflammatory disorder markets.
What critics are saying
- Integration challenges with bit.bio's platform may delay Treg therapy development.
- Increased regulatory scrutiny from FDA RMAT designation could impact timelines.
- Strategic alliances may divert focus from core therapeutic areas, diluting efforts.
What makes BlueRock Therapeutics unique
- BlueRock uses iPSC technology to create novel cellular therapies for complex diseases.
- Their strategic partnerships enhance R&D capabilities and expand therapeutic pipelines.
- Focus on neurology, cardiology, and immunology addresses challenging medical conditions.
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6 month growth
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↓ -2%Newsletter Signup - Under Article / In Page"*" indicates required fields Parkinson’s disease is an extremely complex condition to treat. Although there are medications available that can help relieve symptoms, there are still no approved therapies that slow down the progression of the underlying disease. But the biotech industry has not given up on finding new types of treatments that could potentially change the outcome for people suffering from the debilitating condition, and recent news of positive early-stage results for stem cell therapies has produced new hope for Parkinson’s patients.What are the causes of Parkinson’s disease and current therapeutic approaches?Although the underlying cause of Parkinson’s is unknown, scientists do know that the disease results from a loss of neurons in the substantia nigra region of the brain that make the chemical dopamine, which plays a crucial role in the brain’s reward system, influencing feelings of pleasure, motivation, and movement, as well as impacting mood, attention, learning, and memory. The loss of these neurons subsequently causes dopamine levels to plummet, which is ultimately the driving force behind why patients eventually experience such troublesome symptoms – these generally occur when around 80% of neurons have failed.Right now, the main treatment for Parkinson’s aims to increase the levels of dopamine in the brain. The drug levodopa is considered to be the most effective option, and is often combined with other medications to enhance its effectiveness and reduce side effects. However, not all patients respond to these drugs, and in some cases, doctors even perform surgery to run electrodes deep into the brain to help alleviate tremors and other symptoms.How can stem cell therapy treat Parkinson’s?But what if Parkinson’s could be treated directly at its source by actually restoring the lost neurons?That is exactly what stem cell therapies aim to do
OpCT-001 is the first iPSC therapy candidate licensed from the strategic research and development alliance that FUJIFILM Cellular Dynamics, Opsis Therapeutics, and BlueRock Therapeutics entered in 2021 to discover and develop off-the-shelf iPSC-derived cell therapies for ocular diseases.
Since May 2021, BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics have had an R&D alliance to develop allogeneic iPSC-derived cell therapies for ocular diseases.
The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to bemdaneprocel, a cell therapy BlueRock Therapeutics, a subsidiary of Bayer, is developing to treat Parkinson's disease.
Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year.At one-year, exploratory clinical endpoints improved overall, with participants in the high dose cohort showing greater improvement.One year assessment of all participants demonstrated feasibility of transplantation, cell survival, and engraftment.Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.BERLIN and CAMBRIDGE, Mass., Aug. 28, 2023 /PRNewswire/ -- Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today details of the positive data from the Phase I clinical trial for bemdaneprocel (BRT-DA01), a stem cell derived investigational therapy for treating Parkinson's disease. The data were presented at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.The study met the primary objective of demonstrating safety and tolerability in all 12 participants in the study's low and high dose cohorts, with no serious adverse events (SAEs) reported related to bemdaneprocel through one year. There were two SAEs reported that were unrelated to bemdaneprocel, one seizure attributed to the surgical procedure and one COVID case. Both resolved without sequelae. In addition, 18F-DOPA PET imaging scans demonstrated evidence of cell survival and engraftment in both low and high dose cohorts