Associate Director, Pharmaceutical Safety

1 day ago


Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

We are seeking a highly experienced Clinical Safety Scientist to join our team as an Associate Director, Clinical Safety. In this role, you will be responsible for leading all clinical safety activities for a clinical-stage biotech on a contractual basis.

About the Role:

You will be responsible for managing safety within clinical study teams, providing input to protocol design, investigator brochures, informed consent forms, and investigator notification letters. You will also be responsible for carrying out regular reviews of emerging safety data and presenting important safety issues to senior management and other stakeholders.

Key Responsibilities:
  1. Manage safety evaluation activities including First in Human (FIH) studies.
  2. Author and/or review aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.
Benefits:

This role offers a salary of circa £100 per hour, with the opportunity to work from home 4 days a week and on-site 1 day a week. This provides a great balance between work and personal life.



  • Cambridge, Cambridgeshire, United Kingdom CK Group Full time

    Key Responsibilities:As an Associate Director of Clinical Safety, you will lead all clinical safety activities for assigned compounds.Key Responsibilities:Manage safety within the clinical study teams, providing input to the design and preparation of protocols, investigators brochures, informed consent forms and investigator notification letters.Manage...


  • Cambridge, Cambridgeshire, United Kingdom CK Group Full time £100

    Job OverviewCK Group is currently seeking a highly skilled Clinical Safety Scientist to join their team on a contract basis.This Associate Director level role involves leading clinical safety activities for a clinical-stage biotech.The successful candidate will have experience in managing safety within clinical study teams and have a strong understanding of...


  • Cambridge, Cambridgeshire, United Kingdom CK Group Full time £100

    Clinical Safety Expert - Associate DirectorThis role involves leading clinical safety activities for a clinical-stage biotech company. Responsibilities include managing safety within clinical study teams, providing input to protocol design, and reviewing emerging safety data. The ideal candidate will have significant experience in clinical safety and...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionThe Clinical Safety Operations Director at Bicycle Therapeutics will oversee all safety operations activities, including vendor management, audits, SOPs, and trainings. This role will ensure that all safety SOPs are in place and provide training to vendors, clinical sites, and internal teams.This position will manage all clinical safety...


  • Cambridge, Cambridgeshire, United Kingdom CK Group Full time £100

    About the RoleCK Group is seeking an experienced Clinical Safety professional to lead all clinical safety activities for a clinical-stage biotech on a contractual basis.This Associate Director level role will involve managing safety within the clinical study teams, providing input to the design and preparation of protocols, investigators brochures, informed...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job OverviewBicycle Therapeutics is a pioneering pharmaceutical company developing novel medicines that revolutionize the treatment of underserved diseases. As an Associate Director of Medicinal Sciences, you will play a crucial role in shaping our therapeutic pipeline by designing and executing non-clinical studies to support multiple projects from target...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleWe are seeking an experienced Associate Director Data Operations to lead our safety operations activities. As a key member of the team, you will be responsible for overseeing clinical safety activities for assigned compounds and implementing pharmacovigilance and risk management activities. The successful candidate will have a hands-on...


  • Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group- Science, Clinical and Technical is seeking an experienced Clinical Safety professional to lead clinical safety activities for a clinical-stage biotech on a contractual basis. This Associate Director level role requires significant experience in clinical safety.About the Role:This is an exciting opportunity to join our team as a Clinical Safety...


  • Cambridge, Cambridgeshire, United Kingdom Flagship Pioneering Full time

    Associate Director/Director, Precision OncologyTransforming Human Health and SustainabilityAt Flagship Pioneering, we create, resource, and build life sciences companies that invent breakthrough technologies to transform human health and sustainability. We are seeking a talented and highly motivated Associate Director/Director Oncology to play a vital role...


  • Cambridge, Cambridgeshire, United Kingdom Unreal Gigs Full time

    Pharmaceutical Data Analyst Job DescriptionAt Unreal Gigs, we are seeking a skilled Pharmaceutical Data Analyst to join our team. As a Pharmaceutical Data Analyst, you will play a critical role in analyzing clinical trial data, drug development processes, and market trends.Key Responsibilities:Analyze Clinical Trial Data:Analyze large datasets from clinical...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionThe Clinical Safety Operations team at Bicycle Therapeutics plays a crucial role in ensuring the safety of our medicines throughout their life cycle. As an Associate Director, Clinical Safety Operations, you will lead and oversee all safety operations activities, including vendor management, audits, SOPs, and trainings. Your primary...


  • Cambridge, Cambridgeshire, United Kingdom Sarepta Therapeutics Full time

    Job Title: Associate Director, International BusinessSarepta Therapeutics is seeking an experienced Associate Director, International Business to provide infrastructure support for our International Business Team. This role will play a critical part in ensuring the design, build, and execution of International Business initiatives result in an efficient and...


  • Cambridge, Cambridgeshire, United Kingdom CK Group Full time

    Clinical Safety Expert Wanted!The CK Group is looking for a highly skilled Clinical Safety professional to join their team. As an Associate Director level role, you will be responsible for leading all clinical safety activities for a clinical-stage biotech.Responsibilities Include:Managing safety within the clinical study teams.Providing input to protocol...


  • Cambridge, Cambridgeshire, United Kingdom CK Group Full time

    Job Description for Clinical Safety DirectorCK Group is seeking an experienced Clinical Safety Scientist to lead clinical safety activities for a clinical-stage biotech on a contractual basis.Contract Length: 6 monthsLocation: 4 days a week from home, 1 day a week on-siteRate: Circa £100 per hourResponsibilities:Manage safety within clinical study teams,...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced Senior Director to lead our Global Oncology Therapeutic Area Safety team. The successful candidate will have a strong scientific and clinical background, with expertise in pharmacovigilance and drug safety.Key ResponsibilitiesDevelop and implement global product safety strategies and manage cross-functional...


  • Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Join Hays Senior Finance as an Associate Director of Tax ServicesWe are seeking an experienced tax professional to join our team as an Associate Director of Tax Services. In this role, you will work closely with our clients to deliver expert tax advice and support their business growth. The estimated salary for this role is £100,000 - £130,000 per annum,...


  • Cambridge, Cambridgeshire, United Kingdom taylorollinson Ltd Full time

    At Taylorollinson Ltd, we seek an experienced Senior QA Manager to oversee the quality management system and ensure compliance in our pharmaceutical operations.The OpportunityThis role involves leading a small QA team to achieve cGMP compliance, managing the quality management system, and overseeing various quality-related functions such as CAPAs, risk...


  • Cambridge, Cambridgeshire, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job Title: Senior Director, Quantitative Pharmacology ExpertAbout Regeneron Pharmaceuticals, Inc.Regeneron Pharmaceuticals, Inc. is a leading biotechnology company dedicated to harnessing the power of science to improve people's lives. We are driven by a passion for innovation and a commitment to delivering groundbreaking medicines that make a real...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Bicycle Therapeutics is a pharmaceutical company that specializes in developing novel medicines for underserved diseases.Job SummaryWe are seeking an experienced Associate Director to lead our Drug Safety function and oversee all safety operations activities, including vendor management, audits, SOPs, and trainings. The ideal candidate will have expertise in...


  • Cambridge, Cambridgeshire, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Senior Director, Quantitative PharmacologyRegeneron Pharmaceuticals, Inc is seeking a highly skilled Senior Director, Quantitative Pharmacology to join our team. As a Senior Director in Pharmacometrics, this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio.Key...