Senior Medical Director
3 weeks ago
Senior Medical Director, Drug Safety and Pharmacovigilance page is loaded Senior Medical Director, Drug Safety and Pharmacovigilance
Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R976 Why Join Intellia?
Beyond our science, we live our four core values: We have a single-minded determination to excel and succeed together. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. This is both a strategic and hands-on role for a physician leader with broad experience in drug development and drug safety from biotech and/or pharmaceuticals. If you are a strong problem-solver, agile with regulations and requirements for global safety surveillance & safety risk management in drug development and post-marketing settings, and enjoy cross-functional partnerships, this is the role for you As the Medical Safety Lead, you will lead and work on various projects including but not limited to:
Develop a strategy for Safety surveillance for the clinical trials across the platform in collaboration with the clinical development team
Manage safety signals and lead cross-functional safety management team
Lead a cross-functional project on developing guidance for long-term safety assessment of gene-editing products
Perform medical review of SAEs, SUSARs and aggregate safety data from all sources in collaboration with CRO medical monitors
Lead the development of safety risk management plans, IND annual safety reports
Develop and contribute for IND/BLA safety deliverables and regulatory responses
Develop and contribute for safety surveillance SOPs, participate in PV audit and inspections
Supervise, coach and mentor safety/risk management scientists
Are you an experienced safety physician (MD) with solid clinical experience in direct patient care (clinical experience and/or board certification in Oncology, Immunology, Clinical Genetics desired)? Do you have 10+ years of experience in drug development and in drug safety/pharmacovigilance? If you have these qualifications, and are excited about a leadership opportunity in a fast-paced, growing drug safety & pharmacovigilance department, we encourage you to apply At Intellia, your knowledge and hands-on experience with good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines will contribute to the establishment of a state-of-the-art safety surveillance program for novel gene-editing therapies. have experience leading and authoring safety guidance documents, position papers, safety sections of IND or BLA submission dossiers. You are intrigued by the new challenges to pharmacovigilance that accompanies novel gene editing therapies. Prior experience with gene therapy products or biologics is a plus. You will lead the safety management team for the assigned product(s) with support from safety risk management scientist(s). On a product/program team, you work collectively with all relevant functions for DSPV including medical, clinical operations, data management, biometrics, regulatory, quality and manufacturing.
Intellia strives to form an experienced, patient-focused drug safety & pharmacovigilance (DSPV) function. We are a lean team of experienced PV professionals including a Safety Physician, Safety Risk Management Scientists, PV Operations Lead, and the functional head. Plans are in place to expand our team of knowledgeable and conscientious pharmacovigilance professionals to support our growing portfolio. In your role as Senior Medical Director, Drug Safety & Pharmacovigilance, you will report directly to the Vice President, DSPV.
#Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.
#
-
Senior Medical Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeSenior Medical Director, Drug Safety and Pharmacovigilance page is loaded Senior Medical Director, Drug Safety and Pharmacovigilance Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R976 Why Join Intellia? Beyond our science, we live our four core values: We have a single-minded determination to excel...
-
Senior Medical Director
1 month ago
Cambridge, United Kingdom Relay Therapeutics Full timeAs a Senior Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration. Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution. Working cross-functionally with clinical project management, regulatory affairs, clinical...
-
Senior Medical Director
21 hours ago
Cambridge, United Kingdom Relay Therapeutics Full timeAs a Senior Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration. Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution. Working cross-functionally with clinical project management, regulatory affairs, clinical...
-
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeSenior Medical Director, Drug Safety and Pharmacovigilance page is loaded Senior Medical Director, Drug Safety and Pharmacovigilance Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R976 Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the...
-
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeSenior Medical Director, Drug Safety and Pharmacovigilance page is loaded Senior Medical Director, Drug Safety and Pharmacovigilance Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R976 Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the...
-
Medical Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Purpose The Medical Director will serve as medical lead for MoonLake’s clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities. Key Responsibilities: Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety...
-
Medical Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Purpose The Medical Director will serve as medical lead for MoonLake’s clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities. Key Responsibilities: Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety...
-
Medical Director System Improvement
5 days ago
Cambridgeshire, United Kingdom NHS England Full timeJob summary The NHS England, East of England, Medical Directorate wishes to appoint a Medical Director for System Improvement . This is a key leadership role in the regional health system. In conjunction with other leaders, from across the professional spectrum, the key responsibility of the post is the delivery of high-quality clinical services for...
-
Medical Director System Improvement
7 hours ago
Cambridgeshire, United Kingdom NHS England Full timeJob summary The NHS England, East of England, Medical Directorate wishes to appoint a Medical Director for System Improvement . This is a key leadership role in the regional health system. In conjunction with other leaders, from across the professional spectrum, the key responsibility of the post is the delivery of high-quality clinical services for...
-
Corporate Tax Manager or Director
1 week ago
Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full timeCorporate Tax Manager or Director is required by a highly respected chartered accountants, tax and business advisers, who work in partnership with clients ranging from entrepreneurs and individuals to multinational corporations. As Corporate Tax Manager, you will work with a variety of clients and sectors, mostly in the OMB space, and will be delivering a...
-
Medical Devices Consultant
5 days ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeMedical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...
-
Medical Devices Consultant
4 days ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeMedical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...
-
Medical Devices Consultant
5 days ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeMedical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...
-
Medical Devices Consultant
4 days ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeMedical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...
-
Cambridge, United Kingdom Intellia Therapeutics Full timeSenior Medical Director, Drug Safety and Pharmacovigilance page is loaded Senior Medical Director, Drug Safety and Pharmacovigilance Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R976 Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the...
-
Medical Director
1 week ago
Cambridge, United Kingdom MoonLake Immunotherapeutics Full timeJob Purpose The Medical Director will serve as medical lead for MoonLake’s clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities. Key Responsibilities: Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety...
-
Medical Director
1 month ago
Cambridge, United Kingdom MoonLake Immunotherapeutics Full timeJob PurposeThe Medical Director will serve as medical lead for MoonLake’s clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities. Key Responsibilities:Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety...
-
Senior Planning Associate Director
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeAssociate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and...
-
Senior Planning Associate Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeAssociate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and...
-
Associate Director \/ Director
5 days ago
Cambridge, Cambridgeshire, United Kingdom Lofthouse Group Full timeDirector or Associate Director | Architecture and Design | Cambridge Founder, Lofthouse Group | Headhunter | Architecture & Interiors Director / Partner | Architecture and Design | Cambridge An exciting opportunity for an experienced leader in architecture, to take up a key role in the Cambridge office of a highly respected, world-renowned...
