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Associate Director, Safety Scientist - Boston Massachusetts
Company: Kura Oncology Location: Boston, Massachusetts
Posted On: 04/19/2024
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Essential Job Functions - Provides support to Safety Physician in activities related to monitoring and management of products emerging safety profile.
- Supports the Safety Physician in the development and maintenance of general safety signal management methodologies and product specific signaling strategies. Provides support in the development of risk mitigation strategies.
- Leads signal detection activities (evaluation and tracking) by conducting review and synthesis of key safety information.
- Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature and assists the Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile.
- Reviews safety sections and provides input to various documents including but not limited to: Trial Protocols, Investigator's Brochures, Aggregate Safety Reports (DSUR/PSUR), Annual Reports, Risk Management Plans, and Risk Language for ICFs.
- Interacts with safety and clinical CROs, perform sponsor oversight activities for safety related tasks and reviews safety management or safety reporting plans.
- Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the product Safety Physician across multiple assets.
- Assists the product Safety Physician with the management of the products benefit/risk profile.
- Participates in new study initiation, including but not limited to, safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training, to ensure drug safety requirements are met.
- Supports the preparation of new drug applications with respect to drug safety.\
- Identify opportunities and manage continuous improvement initiatives as related to medical assessment of safety/pharmacovigilance data.
Job Requirements - MS, PharmD, or PhD in Nursing/Pharmacy.
- At least 5 years of clinical safety and pharmacovigilance experience.
- Oncology experience is preferred.
- Knowledge of operational aspects of clinical trial conduct.
- Experience in summarizing and presenting safety data.
- Strong communication skills.
Kura's Values that are used for candidate selection and performance assessments: - We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package |
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