Associate Director/Director, Drug Safety Operations
Job 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. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
A successful candidate in this role is an experienced professional in Drug Safety that will be responsible for interacting/overseeing PV vendor and process improvements for one or more drug products in development. The candidate will be responsible for leading PV vendor oversight, implement key performance indicators for vendor processes, ensuring safety data quality and efficiency in the processes. The candidate will also oversee the authoring of PV aggregate reports (e.g., DSURs), health authority submissions, PV related CAPAs. Strong communication skills, verbal and written, with presentation skills are important in this role. This role will support the Drug Safety department and report to the Executive Director of Pharmacovigilance and Drug safety.
Essential Job Functions
- Oversee and contribute to work performed by the PV/Safety vendor, including establishing Key Performance Indicators (KPIs), in monitoring all work performed by the PV vendor for the Drug Safety function.
- Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s)
- Ensure safety reports received from clinical trials are processed in a consistent and fully compliant manner. Oversee SAE/SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with worldwide reporting requirements).
- Assist with the preparation, and review of, drug safety aggregate reports such as DSURs, maintaining data integrity.
- Assist with/author relevant safety sections in clinical study protocols, Investigator’s Brochures, and other safety documents such as six-month line listings, internal safety assessment reports.
- Assist with processes and initiatives, including but not limited to, audit/inspection readiness, SDEAs/PVAs with partners, represent PV in collaboration with other functions, as needed.
- Assist with the creation and/or review of MSAs, SOWs, invoices and payment of work performed by PV vendors.
- Assist in the creation and approval of PV SOPs and Work Instructions
- Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
- Ensure safety data quality and data integrity is maintained.
- Develop materials and conduct training sessions when appropriate to a variety of audiences
Job Requirements
- Bachelor's degree in a healthcare related field required, such as RN, LPN, PA or PharmD (preferred).
- Minimum of 5 years of experience in Drug Safety/PV, experience within PV Operations.
- In depth knowledge of monitoring health authority submissions,
- Experience working with PV vendors, Alliance partners and managing PVAs/SDEAs.
- Expert knowledge of relevant FDA, EMA, ICH guidelines. and clinical development programs is required. Preferably working knowledge of EMA GVP and CIOMS.
- Experience with PV aggregate reports, signal detection, safety surveillance, literature review, from a PV operational perspective, preferred.
- Drug safety surveillance experience in oncology/hematology preferred
- Ability to interpret related regulatory guidances and problem solve towards a compliance approach with a background and understanding of industry best practices.
- Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives
- Ability to prepare PowerPoint safety presentations
- Ability to work efficiently and effectively with minimal supervision
- Excellent collaboration and communication skills is required
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
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 14 Holidays + 3 Floater Holidays (Including 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
- Cell Phone and Wellness Stiped
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
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 Tipifarnib and ziftomenib. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. ziftomenib is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for ziftomenib at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.
Kura 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.
Date Posted
11/03/2022
Views
24
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