Clinical Compliance Lead
vor 4 Wochen
BeiGene is seeking a highly motivated and experienced Associate Director to lead our Global Clinical Compliance team. As a key member of our Clinical Operations department, you will be responsible for implementing and maintaining our global clinical compliance strategy, ensuring that our clinical trials are conducted in accordance with applicable regulations and guidelines.
Key Responsibilities:- Develop and implement global clinical compliance strategies and procedures to ensure compliance with regulatory requirements.
- Provide compliance and quality support to our global clinical teams, ensuring that our clinical trials are conducted in accordance with applicable regulations and guidelines.
- Identify and mitigate compliance risks, ensuring that our clinical trials are conducted in a compliant and quality manner.
- Collaborate with our Quality Assurance and Regulatory Affairs teams to ensure that our clinical trials are conducted in accordance with applicable regulations and guidelines.
- Develop and implement metrics and monitoring programs to ensure constant vigilance with respect to compliance activities.
- Provide education and training to our clinical teams on compliance and regulatory requirements.
- Bachelor's degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline.
- Minimum of 10 years of experience in pharmaceutical or biotechnology drug development, with a minimum of 5 years in a compliance or regulatory affairs role.
- Experience in global oncology trials preferred.
- Excellent written and verbal communication and interpersonal skills.
- Ability to work independently in a multi-cultural setting and effectively handle multiple priorities in a fast-paced environment.
- Strong understanding of clinical trial processes and regulatory requirements.
- Excellent analytical and problem-solving skills.
- Ability to work effectively in a team environment.
- Strong communication and interpersonal skills.
- Ability to adapt to changing priorities and deadlines.
- Competitive salary and benefits package.
- Opportunity to work with a dynamic and growing company.
- Collaborative and supportive work environment.
- Professional development opportunities.
BeiGene is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.
-
Clinical Trials Operations Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz IQVIA VollzeitClinical Trials Operations LeadWe are seeking a highly skilled Clinical Trials Operations Lead to join our team at IQVIA. In this role, you will be responsible for leading the Study Management Team and ensuring the regional/global coordination of clinical trial management activities.Manage clinical trial planning, execution, and closureLead the Study...
-
Clinical Trial Regulatory Lead
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleClinical Trial Regulatory LeadAt Roche, we are committed to developing and maintaining the highest standards of regulatory excellence. As a Clinical Trial Regulatory Lead, you will play a critical role in shaping the regulatory strategy for our clinical trials, ensuring compliance with global regulations and guidelines.Your Key...
-
Clinical Trials Regulatory Lead
vor 1 Woche
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleClinical Trial Regulatory LeadAt Roche, we are committed to developing life-improving therapies worldwide. As a Clinical Trial Regulatory Lead, you will play a crucial role in shaping our regulatory strategy and submissions globally (excluding US, China, and Japan) for molecules and medical devices.You will work closely with early research and...
-
Regulatory Lead for Clinical Trials
vor 1 Woche
Basel, Basel-Stadt, Schweiz Roche Vollzeitbody {font-family: Arial, sans-serif;}Job SummaryWe are seeking a highly skilled Clinical Trial Regulatory Lead to join our team at Roche. As a key member of our Pharma Development Regulatory organization, you will be responsible for leading the clinical trial regulatory strategy and submissions globally (excluding the US, China, and Japan) for molecules and...
-
Global Clinical Development Leader
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob DescriptionThe Global Program Clinical Head is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.This role owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a...
-
Clinical Compliance Specialist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe PositionIMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (IMPs) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and are responsible for the Quality and Compliance oversight of...
-
Global Clinical Development Leader
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob DescriptionThe Global Program Clinical Head is a key leadership role responsible for overseeing the clinical development of one or more programs across indications. This individual will lead the Global Clinical Team, representing Clinical Development on the Global Program Team, and will be accountable for the design, implementation, and execution of...
-
Compliance & Ethics Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Bio-Rad VollzeitThe Compliance & Ethics Lead will serve as a trusted advisor to Bio-Rad workforce members and business partners operating within the EMEA region. This role will assist in the implementation of a compliance and ethics program aligned with Bio-Rad's mission, vision, and values.Key Responsibilities:Collaborate with the Corporate Compliance team to identify...
-
Senior Clinical Development Director
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitRole Overview:As a Senior Clinical Lead at Ridgeline Discovery GmbH, you will drive our clinical development pipeline, working closely with program leaders, internal and external experts, and a Contract Research Organization (CRO) to design and implement clinical development strategies.Key Responsibilities:Clinical Development Strategy: Develop and execute...
-
Compliance and Ethics Leader
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Bio-Rad Laboratories VollzeitKey Responsibilities:The Compliance and Ethics Lead will serve as a trusted advisor to the Bio-Rad workforce and business partners, assisting in the implementation of a compliance and ethics program aligned with Bio-Rad's mission, vision, and values.This individual will collaborate with regional compliance officers to revise global policies, develop global...
-
Neuroscience Clinical Development Lead
vor 1 Woche
Basel, Basel-Stadt, Schweiz Roche VollzeitKey ResponsibilitiesAs a Lead Medical Director in our Neuroscience Clinical Development team, you will play a crucial role in the late-stage development of our MS product. Your primary responsibilities will include leading the design, development, and execution of clinical studies, as well as collaborating with cross-functional teams to develop product...
-
Compliance and Ethics Lead
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Bio-Rad Laboratories VollzeitJob SummaryJoin Bio-Rad Laboratories, a global leader in life sciences, as a Compliance and Ethics Lead. This role is responsible for implementing and maintaining a compliance and ethics program in alignment with Bio-Rad's mission, vision, and values.Key ResponsibilitiesCollaborate with regional compliance officers to revise global policies and develop...
-
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitAbout the RoleWe are seeking a highly motivated and experienced Senior Clinical Lead to join our team at Ridgeline Discovery GmbH. As a key member of our clinical development team, you will be responsible for driving our pipeline forward, working closely with program leaders, internal and external experts, and a CRO to design and implement clinical...
-
Senior Clinical Development Director
vor 1 Woche
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitSenior Clinical Lead Early Clinical Development Job DescriptionSixPeaks Bio, a leading biotechnology company, is seeking a highly skilled Senior Clinical Lead Early Clinical Development to drive the company's clinical development pipeline. As a key member of the team, you will be responsible for designing and implementing clinical development strategies,...
-
Digital Biomarker Clinical Integration Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleWe are seeking a highly skilled Digital Biomarker Clinical Integration Manager to join our team at Roche Information Solutions.This is an exciting opportunity to contribute to the development of innovative digital remote monitoring concepts for sensitive and meaningful drug development endpoints.Develop and execute digital biomarker strategies to...
-
Clinical Development Director
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Mirum Pharmaceuticals VollzeitTransforming Rare Diseases TreatmentMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Our mission is to turn possibilities into realities using data and meaningful evidence.Associate Director, Clinical DevelopmentThe Associate Director, Clinical Development will join...
-
Clinical Development Leader for Rare Diseases
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitIronwood Pharmaceuticals is a leading global healthcare company dedicated to advancing the treatment of gastrointestinal (GI) diseases and redefining the standard of care for GI patients. As part of VectivBio, we are focused on discovering, developing, and commercializing innovative treatments for severe rare conditions with high unmet medical need.The...
-
Clinical Trials Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the Role:We are seeking a highly skilled Clinical Trials Manager to join our team at Neurocrine Biosciences. As a key member of our clinical operations team, you will be responsible for managing the operational activities of clinical studies, from planning and initiation to conduct and close-out phases.Your Key Responsibilities:Develop, lead, and...
-
Basel, Basel-Stadt, Schweiz Lonza VollzeitAt Lonza, we're driven by a passion for life sciences and a commitment to excellence. As a Laboratory Manager for Clinical Quality Control and Physico Chemical Analytics, you'll play a critical role in ensuring the quality and integrity of our products.Key Responsibilities:Lead and manage a Clinical QC Phys-Chem analytical laboratory, ensuring GMP compliance...
-
Basel, Basel-Stadt, Schweiz Lonza VollzeitJoin Our Team as a Laboratory ManagerWe are seeking a highly skilled Laboratory Manager to lead our Clinical Quality Control Physico Chemical Analytics team. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our laboratory operations.Key ResponsibilitiesLead and manage a Clinical QC Phys-Chem...