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Vice President, Head of Neurology Clinical Development

Added
12 days ago
Location
Type
Full time
Salary
$350K - $400K

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Related skills

cross-functional leadership neurology clinical development cell therapy regulatory strategy

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Leveraging our proprietaryCELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

Our Neurology Vision

BlueRock is advancing an innovative pipeline of cell therapies in neurology, focused on addressing the urgent needs of patients with neurodegenerative and neurological disorders. Our lead neurology program,bemdaneprocel (DA01), is a first-in-class, allogeneic cell therapy designed to replace lost dopaminergic neurons in patients with Parkinson’s disease. This program is currently in phase 3 development with the exPDite-2 clinical trial ongoing in the US, Canada, and Australia. Additional neurology pipeline assets, includingDA02andMG0X, are in research phase targeting other high-impact neurological conditions.

Our goal is to restore function, slow or halt disease progression, and transform the standard of care for patients with debilitating neurological diseases.

What Are We Doing?

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies. We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

About the Role

As BlueRock advances bemdaneprocel, DA02, MG0X, and other pipeline programs in neurology, we are seeking a visionary leader to join our team asVice President, Head of Neurology Clinical Development. In this highly visible role, you will lead the clinical strategy and execution for our neurology cell therapy programs from IND-enabling studies through clinical development and regulatory submissions.

Reporting to the Chief Medical Officer, you will build and lead cross-functional teams, collaborate with internal and external partners, and play a pivotal role in shaping the future of cell therapy for neurological diseases. This position can be based in Cambridge, MA or New York City, NY, with remote or hybrid work arrangements available.

Key Responsibilities

  • Scientific & Clinical Leadership
  • Provide strategic and operational leadership for BlueRock’s neurology pipeline, including bemdaneprocel (DA01), DA02, MG0X, and future programs targeting Parkinson’s disease and other neurodegenerative disorders.
  • Serve as the primary clinical expert and thought leader internally and externally for neurology clinical development.
  • Clinical Program Development
  • Design and oversee execution of clinical studies, including protocol development, study reports, and regulatory submissions (IND, BLA).
  • Lead the translation of preclinical findings into clinical strategy and execution.
  • Cross-Functional Team Leadership
  • Build, inspire, and lead high-performing, cross-functional teams (research, regulatory, CMC, clinical operations, IP, etc.) in a dynamic, matrixed environment.
  • Foster a culture of innovation, collaboration, and scientific excellence.
  • Strategic Partnerships
  • Establish and maintain relationships with leading academic collaborators, investigators, and thought leaders in neurology, cell and gene therapy, and translational medicine.
  • Represent BlueRock at key scientific and medical conferences.
  • Establish and maintain collaborative relationships with colleagues at our parent company Bayer
  • Regulatory Strategy
  • Lead clinical content and contribute to overall strategy for regulatory interactions and submissions, ensuring alignment with global standards and regulatory authorities (FDA, EMA, PMDA, etc.).
  • Mentorship & Team Development
  • Mentor and develop Medical Directors and Clinical Development Scientists, fostering innovation, teamwork, and excellence.
  • Business Integration
  • Provide clinical perspective to overall business strategy, integrating commercial, competitive, and scientific viewpoints.
  • Innovation
  • Champion the development and implementation of novel clinical trial designs and methods in neurology and cell therapy.
  • Minimum Requirements

  • MD or MD/PhD (or equivalent medical degree); subspecialty training in neurology strongly preferred.
  • Minimum 10 years of pharmaceutical/biotechnology industry experience, with a proven track record in clinical development (including IND and/or BLA filings).
  • Demonstrated leadership in cross-functional, matrixed team environments and a history of advancing innovative therapies.
  • Deep understanding of neurology clinical trial design, execution, and regulatory requirements; global experience a plus.
  • Experience with cell and gene therapy clinical programs highly desirable.
  • Excellent communication, critical thinking, and strategic planning skills.
  • Commitment to fostering a culture of pioneering science and patient-centric innovation.
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