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Senior Medical Director, Clinical Development

Employer
BlueRock Therapeutics
Location
Cambridge, Massachusetts
Start date
Mar 17, 2023

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Discipline
Clinical, Clinical Development, Clinical Research
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Genetown
Who 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.
It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patients’ lives across multiple disease areas.
In this highly visible role, the Medical Director, Clinical Development, Neurology will be charged with developing and leading novel internal and externally partnered programs in the Neurology Cell Therapy space. This role will provide guidance to research teams and lead more advanced IND-enabling and clinical-stage activities, with a key focus on creating development strategies.
Reporting to Vice President, Clinical Development, Neurology this role will build, contribute, and lead well-balanced, highly productive, cross-functional development teams (such as research, regulatory, genome engineering, CMC, clinical development and operations, and IP) within a dynamic matrixed environment. They will manage partnerships with BlueRock’s academic founders as well as internal and external research sites spanning company locations in Berlin, Toronto, New York, and Cambridge. The position will be based in Cambridge, MA.Responsibilities
  • Bring scientific leadership to neurology programs (e.g. Parkinson’s Disease, Rare Neurologic Disorders), inclusive of management of a scientific team.
  • Responsible for design and execution of global clinical studies
  • Lead or oversee development of study related documents including protocols and study reports
  • Provide strategic input into the research direction of Neuroscience cell programs by interaction with external academic collaborators and internal leadership teams.
  • Strategic evaluation of diseases of interest to BlueRock and integration in the development vision and planning
  • Establish, grow, and maintain key relationships with global leaders in Neurology, cell and gene therapy, and translational medicine fields, including BlueRock Advisory Boards.
  • Provide oversight to collaborative programs and maintain strong relationships with investigators and key opinion leaders in the field with national and international exposure.
  • Manage timelines and maintain department budget.
  • Lead and provides strategic input to ensure optimized development planning in close collaboration with other senior functional leads
  • Lead and oversee the clinical content and contribute to the overall strategy in all regulatory submissions and interactions
  • Mentor Medical Directors and Clinical Development Scientists, and promote research of innovative clinical trial methods, teamwork and quality
  • Participate in establishment of efficient processes, standards and SOPs
  • Consult with and support other functions including Research and Preclinical Development
  • Provide a clinical perspective to the overall business strategy, incorporating commercial and competitive viewpoints, and effectively communicate scientific and medical data results/information to all internal and external stakeholders globally
  • Minimum Requirements
  • MD or MD/PhD (or equivalent medical degree) is required.
  • Pharmaceutical/biotechnology industry experience with a demonstrated track record in scientific research and clinical development
  • Proven ability to lead by example within a collaborative, dynamic, high growth culture, championing and advancing novel concepts within cross-functional matrixed teams
  • An innovative, results-oriented, solutions focus and critical thinking skills
  • The motivation to build a culture of pioneering science with aspirations to develop products that will change the lives of people with serious diseases
  • Extensive regulatory interactions experience
  • Innovative focus and ability to champion and advance novel concepts
  • Working Environment
  • Full time
  • Remote or hybrid can be arranged  
  • BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock 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
    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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