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Associate Director, Clinical Sciences

bluerocktx · 27 days ago
Negotiable
Full-time
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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.

The Associate Director, Clinical Sciences, Ophthalmology will be charged with providing medical and scientific support for BlueRock’s Ophthalmology programs. Reporting to the Senior Director, Clinical Development, Ophthalmology, this role will work closely with clinical and program leads as well as other subject matter experts to expand and execute on the company’s development pipeline. The successful candidate will be a clinical scientific resource and will collaborate with internal and external Clinical Development partners.  The position will be based in Cambridge, Massachusetts.

Responsibilities:

  • Provide scientific and medical contribution to the design and execution of clinical trials
  • Collaborate on, or lead where appropriate, the preparation of clinical study related documents including protocols, clinical study manuals, ICFs, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
  • Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies
  • Provide support for the medical monitoring and safety oversight of clinical trials in collaboration with the team’s medical representatives
  • Perform clinical review of data listings and essential study data within generated statistical reports  and other data surveillance tools,  and partner with Data Management in generating relevant queries
  • Contribute to the analysis, interpretation and reporting of clinical studies
  • Provide clinical and scientific content and contribute to the overall strategy in regulatory submissions and interactions
  • Liaise with clinical operations for study execution related activities, including site selection, site start-up activities, investigator meetings, screening and enrollment planning, protocol amendments, etc
  • Support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures
  • Support the preparation of internal and external scientific and clinical study related documents, and effectively communicate scientific and medical data results/information
  • Contribute to (or lead) targeted research and literature reviews with good judgement on the weight of evidence to support the clinical development strategy
  • Contribute to (or lead) specific research efforts to support ongoing clinical programs
  • Contribute to the assessments of potential new products or programs 

Minimum Requirements:

  • A doctoral degree (OD, MD, PharmD, or PhD in life science) required
  • A minimum of 5 years of Pharmaceutical/Biotechnology experience
  • Experience in cell or gene therapy and ophthalmology is preferred
  • Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Able to work independently
  • Strong judgement and decision-making skills
  • Intellectual curiosity, flexibility and persistence
  • Ability to collaborate cross-functionally and with external stakeholders

Working Environment:

  • Full time
  • Remote or hybrid can be arranged  
#LI-AL1

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.

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.

Last updated on Mar 20, 2024

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