Senior Director, Head of Global Safety & Pharmacovigilance
- Employer
- BlueRock Therapeutics
- Location
- Cambridge, Massachusetts
- Start date
- Mar 17, 2023
View more
- Discipline
- Administration, Clinical, Drug Safety/Pharmacovigilance
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Genetown
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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.
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 newly created and highly visible role, the Head of Global Safety and Pharmacovigilance will report directly to the Head of Development and will be responsible for developing BlueRock’s Safety and PV capabilities. This role will be responsible for providing leadership and clinical support to drug safety data management, safety data interpretation, safety operations, benefit risk assessment and risk management activities.Responsibilities:Responsible for BlueRock’s Safety and Pharmacovigilance strategy and execution Lead BlueRock's Drug Safety Management Committee Work jointly with Clinical Development and Regulatory Affairs to provide oversight of drug safety for programs in clinical development Actively participate in oversight of patient safety in all ongoing clinical trials Lead safety signal management activities in partnership with Clinical Development and other stakeholders Lead Safety and Pharmacovigilance related vendor selection, management, and oversight of deliverables for BlueRock’s clinical trials Develop BlueRock’s Core Safety Information Contribute written summaries and assessments for safety components of protocols statistical analysis plans, clinical study reports, etc. Oversee/review safety sections of periodic aggregate reports Ensure compliance with global safety reporting requirements and ensure inspection readiness Develop and manage expertise in drug safety Provide safety review of clinical study documents including protocols, study reports, regulatory submission components Build BlueRock's Global Safety and PV organization aligned with the requirements of expansions in the clinical activities of the company Minimum Requirements:MD (or equivalent) is required. Pharmaceutical/biotechnology industry experience with a demonstrated track record in Safety and Pharmacovigilance operations and safety assessment including assessment of benefit risk in clinical development Expert knowledge of FDA/EU clinical safety regulations other applicable regulatory guidance documents; expertise in global safety regulations Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process Expertise in clinical safety assessments, safety signal detection, benefit risk assessment and risk management, including leading interactions with regulatory authorities Demonstrated ability to solve problems with innovative solutions along with strong organizational skills Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills Proven ability to lead by example within a collaborative, dynamic, high growth culture, championing and advancing novel concepts within cross-functional matrixed teams 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 Working Environment:Full time In-person or hybrid can be arranged #LI-AL1
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.
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 newly created and highly visible role, the Head of Global Safety and Pharmacovigilance will report directly to the Head of Development and will be responsible for developing BlueRock’s Safety and PV capabilities. This role will be responsible for providing leadership and clinical support to drug safety data management, safety data interpretation, safety operations, benefit risk assessment and risk management activities.Responsibilities:
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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