Associate Director/Director, Drug Safety Operations New Boston, Ma

Associate Director/Director, Drug Safety OperationsAre 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 Pharmacovigilance (PV)/Drug Safety that will be responsible for overseeing the PV vendor and process improvements, for Kura Oncology products. The candidate will be responsible for leading PV vendor oversight, implementing and monitoring key performance indicators for vendor processes, ensuring safety data quality and efficiency in the processes. The candidate will oversee workflow compliance, health authority submissions, investigation of PV related CAPAs, etc. The candidate will work cross-functionally, as needed, with key stakeholders and external resources on PV-related matters. 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. Key responsibilities of the role include, but not limited to:
Essential Job Functions Oversee and contribute to the work performed by the PV vendor, including establishing Key Performance Indicators (KPIs) and monitoring all activities related to the Drug Safety function.Accountable for coordinating day-to-day operational Individual Case Safety Report (ICSR) activities in collaboration with designated management personnel at the vendor site(s).Create and/or assist with the creation of training materials, and lead training sessions for all PV processes, providing oversight to the PV vendor and CROs supporting PV activities.Ensure that safety reports received from clinical trials are processed in a consistent and fully compliant manner.Oversee expedited and periodic reporting activities for all investigational drugs, maintaining oversight to ensure that the global clinical trials case reporting process is efficient and compliant with worldwide reporting requirements.Assist with processes and initiatives, including but not limited to audit/inspection readiness and SDEAs/PVAs with partners, representing PV in collaboration with other functions as needed.Assist with the creation and/or review of Master Service Agreements (MSAs), Statements of Work (SOWs), invoices, and payment for work performed by PV vendors.Author and/or review PV Standard Operating Procedures (SOPs), Work Instructions, and Safety Management Plans (SMPs) in collaboration with other PV team members and cross-functional teams, as applicable.Oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, as well as deviations related to case management processes, as defined in the SMPs or SOPs.Ensure that safety data quality and data integrity are maintained.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, within a pharmaceutical, biotechnology or related environment, including time spent in a leadership/managerial role within PV Operations.In depth knowledge of monitoring health authority submissions, CAPAs and relationships between vendors.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.Experience in oncology/hematology preferred.Ability to interpret related regulatory guidance 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.Excellent strategic decision-making and analytical skills.Ability to work efficiently and effectively with minimal supervision.Excellent collaboration and strong written and communication skills is required.The base range for an Associate Director is $169,000 - $201,000 and a Director is $216,000 - $253,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus. 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 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!Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of blood cancers and solid tumors. 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, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). For additional information, please visit Kura's website at www.kuraoncology.com and follow us on X and LinkedIn.
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.

#J-18808-Ljbffr