- 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.
- 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.
- 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
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more
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Associate Director, Safety Scientist - Boston, United States - Kura Oncology, Inc.
Description
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.
Essential Job Functions
Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers.
The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment.
Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806.
Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need.
Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML.Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML.
Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC.
Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.
For additional information, please visit Kura's website atKura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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