Associate Director / Director, Drug Safety Operations

Associate Director / Director, Drug Safety Operations

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.

We are seeking an experienced and strategic Associate Director / Director of Pharmacovigilance Operations to lead and evolve our global PV operational infrastructure. This is a high-impact role for someone with strong operational acumen and experience managing outsourced PV models in a biotech or fast-paced pharma environment. This role is accountable for the oversight of all outsourced safety operations, vendor governance, and operational compliance across clinical and post-marketing settings. The Associate Director / Director, PV Operations will play a critical role in scaling PV operations capabilities, ensuring inspection readiness, regulatory compliance, and contributing to strategic safety planning as the company transitions through late-phase development and into commercialization. The ideal candidate has experience supporting both clinical and post-marketing programs and can lead vendor governance, inspection readiness, and PV systems management.

This role will support the Pharmacovigilance department and report to the Executive Director of Pharmacovigilance and Drug Safety. Key responsibilities of the role include, but not limited to :

Oversee the process for ICSR collection, processing, reconciliation, and reporting, including associated quality activities to ensure regulatory timelines and global standards are met.

Provide oversight and support of the PV vendor activities, including establishing and monitoring key performance indicators (KPIs), always ensuring inspection-readiness.

Oversee global compliance with pharmacovigilance regulations, including timely ICSR submissions, quality case processing, and aggregate reporting support

Oversee the lifecycle of PV operational SOPs, work instructions, and guidance documents, providing oversight to the PV vendor and CROs supporting PV activities.

Support in the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs), with license partners and / or other parties.

Support reconciliation activities between safety and clinical databases, as well as partner case exchanges.

Support safety database configuration and maintenance, as required.

Support PV audit and inspection activities, as required, and serve as SME during these activities.

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.

Collaborate with Clinical Operations to deliver safety communications to sites and ethics committees.

Assist with PV processes and initiatives, representing PV in collaboration with other functions as needed.

Work cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and Medical Affairs to ensure appropriate PV processes are in place and adhered to.

Serves as key point of contact between PV and the CROs regarding PV operation management.

Provide PV operational expertise in development of RMPs, REMS, DSURs, PSURs, and other safety deliverables.

Represent PV operations in internal safety governance forums and external collaborations / partnerships

Participate in cross-functional monitoring of study data, as necessary.

Assist in the development, review and management of departmental budget, MSAs, SOWs, invoices and payment of work performed by vendors.

Job Requirements :

Degree in Life Sciences, Pharmacy, Nursing or related field required.

Minimum of 10 years of Pharmacovigilance experience within a pharmaceutical, biotechnology or related environment, with time spent in a leadership / managerial role within PV Operations.

Hands-on experience in vendor oversight, including governance, ensuring adherence to KPIs, and managing PVAs / SDEAs.

Expertise in managing outsourced PV models and developing vendor oversight frameworks.

Experience in pre- and post-marketing Safety, with proven success in biotech or small / mid-sized pharma, ideally in a lean team setting.

Experience supporting late-stage clinical programs and regulatory submissions (e.g, NDA / BLA / MAA).

In-depth knowledge of monitoring health authority submissions, CAPAs and relationships between vendors.

Strong understanding of global PV regulatory requirements and timelines (e.g. FDA, EMA, PMDA, E2B R3, etc) and PV Systems (e.g. Argus, Arisglobal, Vault Safety) required.

Experience working with clinical databases preferred.

Experience with PV aggregate reports, signal detection, safety surveillance, literature review, from a PV operational perspective, is preferred.

Able to work independently, establish work priorities, and execute decisions with minimal guidance.

Experience in oncology / hematology is preferred.

Ability to interpret related regulatory guidance and problem-solve towards a compliance approach with a background and understanding of industry best practices.

Excellent strategic, decision-making and analytical skills.

Excellent collaboration and strong written and verbal communication skills are required.

The base range for an Associate Director is $169,000 - $203,000 and a Director is $218,000 - $255,000 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 :

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!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed / refractory ("R / R") NPM1 -mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R / R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R / R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 20