Kura Oncology, Inc.

Account Manager

• Achieve the assigned sales objective for the territory
• Attain the designated goals for calls on appropriate healthcare professionals to communicate balanced, accurate, and complete information on Kura’s FDA approved products
• Develops and implements a territory business plan to meet customer needs and achieve goals
• Navigate through complex external/customer organizational structures including hospitals, IDNs, GPOs and healthcare communities while aligning with cross-functional commercial partners
• Demonstrate completion of administrative requirements including budget management, expense reports management, CRM call reporting and synchronization, etc. within timelines and company guidelines
• Demonstrates a deep understanding of healthcare professionals (HCP) and account needs, effectively utilizing this knowledge to strategically promote and expand the use of assigned products
• Operate the territory within the assigned expense budget and demonstrates fiscal responsibility
• Comply with all federal/state/local laws, regulations and guidelines including but not limited to the PhRMA Code on Interactions with Healthcare Professionals as well as complying with all Kura standards and policies relating to all job activities
• Successful completion and ongoing updates of all aspects of training including but not limited to product knowledge, disease state, market, selling skills and compliance
• Assists in the identification and resolution of issues and opportunities while communicating proactively to marketing and sales management
• Develops and consistently demonstrates an expert understanding of HCP and Account needs to appropriately expand use of assigned product.

Oncology Account Manager

Operations

• The Manager, Biosample Operations plans, implements, manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials, working within our Clinical Operations function, under the leadership of the Head of Clinical Operations (or designee) and in collaboration with Clinical Trial Leaders (CTLs) and cross-functional development team.
• The Manager, Biosample Operations advises on and delivers the biosample strategy within clinical program(s) in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
• Ensures standardization and harmonization of biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation, maximizing biosample sample accrual and quality.
• Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.
• Responsible for ensuring ethical use of biosamples collected in Kura Oncology clinical trials.
• Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition)
• Ensures project level consistency occurs for biosampling across studies and is the primary point of contact for project, clinical, and study teams; contributing to innovation and improvement activities in collection, processing and data delivery.
• Track and report on biosample management status/progress, address issues, and resolutions.
• Collaborate with internal and external team members
• Complete other duties as assigned by the manager.

Manager, Biosample Operations

Content Writer

• The Senior Director, Medical & Regulatory Writing serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books.
• May also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings.
• The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment.
• The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates.
• There will need to be a very strong understanding of document timelines as planning is critical.