ESSENTIAL JOB FUNCTIONS:

• Manage Senior Accountant and ensure timely, accurate processing of journal entries, reconciliations and various account analyses for R&D functions such as translational research, development, diagnostics, pharmacology, and regulatory affairs, and adherence to company policies.
• Review and approve invoices for payment. Ensure proper coding, two-way match, and approval workflows.
• Perform and review journal entries and balance sheet reconciliations for key accounts such as accrued R&D contracts, prepaid R&D ST, and prepaid R&D LT.
• Review various related parties and partner transactions including reconciliations, and analysis.
• Perform and review monthly and quarterly variance analyses for operating expenses, R&D functions, projects, and key accounts; investigate and resolve discrepancies proactively.
• Ensure compliance with U.S. GAAP, SOX requirements, and internal accounting policies across all responsible functions and processes.
• Support the design, implementation, and ongoing maintenance of Sarbanes‑Oxley internal controls, including documentation and testing.
• Assist with external financial audits by preparing schedules and responding to auditor requests and inquiries.
• Review monthly purchase order coding, partner with project managers and accounting staff to ensure proper coding for all new purchase orders.
• Apply strong analytical skills and critical thinking to identify issues, recommend improvements, and enhance the accuracy, efficiency, and quality of accounting processes.
• Perform additional duties and ad hoc projects as needed to support Finance leadership and departmental goals

Job Specifications:

• Bachelor’s degree in accounting, or other related discipline, or the equivalent knowledge and experience required.
• Experience in the biotech/pharmaceutical industry required
• A minimum of 6-8 years’ relevant accounting experience, preferably in a combination of the following monthly close process, bank reconciliations, balance sheet reconciliations, contract accruals
• Excellent communication and people skills and the ability to interface with various levels of co-workers, upper management, and external customers while maintaining a high degree of confidentiality.
• Experience working in publicly traded company and life science industry preferred.
• Knowledge of US GAAP and internal control principles for a public corporation.
• ERP experience required; experience with NetSuite, Blackline, Coupa and Concur preferred.
• Skilled in the use of Microsoft Office Suite with intermediate to advanced Excel skills.
• Detail oriented with good analytical skills.
• Exercises independent judgment in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross-functional decisions.
• Serves as a key point of contact for cross-functional partners withing their area, ensuring alignment and proactively addressing coordination needs to support team deliverables.
• Strong time management skills and ability to independently organize multiple tasks of varying priorities and meet critical deadlines in a fast-paced environment.
• Ability to work in team environment and willing to assist other team members to achieve team goals and objectives.

The base range for this role at a Senior Manager level is $143,000 - $176,500. 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.

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The Regional Sales Director will lead a field sales team from training, launch excellence and sustainable sales achievements. They will work with the field sales team and in partnership with all cross functional partners to support commercial excellence and positive experiences with all customer segments. The Regional Sales Director will ethically and compliantly deliver sales goals at or above targeted plans for all given measurement periods for their geographical areas of responsibility.

Essential Job Functions

• Identify, recruit, hire, train, develop, motivate and retain top performing field sales personnel
• Prepare field-level action plans and lead and manage the behaviors needed to support the successful execution of the plans
• Field expert in market, competition, disease state, customer segments and commercial opportunity landscapes
• Understand and interpret sales and data reports and apply proactively and reactively clear and specific direction to drive specific behaviors and sales performance
• Establish and build key customer relationships to provide appropriate clinical and business support to drive area performance
• Effectively, efficiently and appropriately triage internal and external customer needs, issues and request in order to lower or remove barriers to core success factors
• Coach, teach and lead teams to engage customers in order to establish the foundation of disease awareness, appropriate patient profiles and compliant product utilization
• Execute recurring field visits with field team and provide timely written and verbal feedback
• Work with and partner with marketing, training, access and operations to deliver strategic imperatives while providing real-time feedback and suggestions on areas to continually improve organizational and operational excellence
• Constantly evaluate all internal and external factors in order to provide suggestions and guidance on more effective ways to meet and exceed goals
• Be the field facing lead for establishing the Kura Oncology name within the oncology-hematology community
• Fiscal responsibility and budget management to achieve maximize sales results
• Maintains highest level of compliance and ethics for self, team and organization

Job Requirements

• Undergraduate degree required, ideally in business/marketing/healthcare/life science areas of concentration
• 10+ years of pharmaceutical/biotech commercial experience within the oncology/hematology and/or rare disease markets, with a minimum of 5 years of experience managing direct reports and leading teams in oncology and/or rare disease
• Successful and documented track record of attracting, developing and retaining talent and building high performing teams
• Experience in pharmaceutical/biotech marketing, managed care/market access, commercial operations and/or sales training a plus
• Launch preparation and successful launch experience in oncology/hematology; rare disease experience a plus
• Strategic and analytical thinking as demonstrated by key projects/initiatives
• Strong cross-functional leadership skills and ability to collaborate effectively within various groups
• Managerial Courage
• Excellent written and oral communication skills
• Strong computer skills, notably WORD, EXCEL and POWER POINT

The base range for the RSD is $268,000 - $312,000 per year with a target bonus of $90,000. 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.

ESSENTIAL JOB FUNCTIONS:

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. This role leads and is accountable for the Medical Writing and Clinical Trial Transparency & Disclosure functions. 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.

• Provides leadership, strategy, and oversight of the Medical & Regulatory Writing team.
• Serves as subject matter expert in preparing clinical regulatory documents through all phases clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• Oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for medical writing
• Performs other duties as assigned

JOB SPECIFICATIONS:

• Bachelor’s, Master’s or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Ph.D. degree is preferred.
• Strong track record of people management and delegating work.
• 12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure. Experience authoring and managing briefing books is a plus.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Must have the ability to edit text for brevity and clarity.
• Ability to understand, interpret and present complex clinical data.
• Must be highly detail oriented.
• Ability to coordinate multiple documents while effectively managing timelines.
• High degree of independence in decision making and problem solving.
• Leads decision-making across multiple programs or areas, setting direction and making strategic trade-offs that impact cross-functional execution and outcomes.
• Drives cross-functional alignment across multiple programs, influencing stakeholders to shape strategy and ensure cohesive execution across functions.
• Understanding of FDA and ICH regulations and guidelines.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.
• Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project.
• Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

The base range for this role at the Senior Director level is $265,000 - $306,000 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.

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ESSENTIAL JOB FUNCTIONS:

• Day-to-day operation and maintenance of laboratory and office facilities.
• Organize and help maintain the lab, manage the lab consumable inventory, take care of stocking supplies, schedule refrigerator/freezer cleanings, pipette calibrations, maintain organization of the lab inventory.
• Order, stock, and track inventory which includes reagents, consumables, first aid items, and other lab and office supplies.
• Arranging FedEx Shipments and receiving deliveries.
• Manage service providers and vendor contracts related to the maintenance, calibration, and repair of facility and utility equipment and building systems.
• Maintain the labs facility and utility practices, policies, and procedures
• Coordinate the instrument preventive maintenance schedule.
• Ensures adherence to lab standards and practices to maximize safety and operational effectiveness
• Responsible for lab shipments to/from company while maintaining safe shipping and handling standards.
• Manage all chemical and biological waste streams, including proper storage, labeling and disposal.
• Maintain required Chemical Inventory.
• Manage system for Safety Data Sheet (SDS) record keeping.
• Track warranty expirations and contact vendors for renewal.
• Drive continuous improvement in all aspects of the laboratory operations
• Provide excellent customer service when interacting with lab users, third party vendors, and other departments
• Proactive communication with end users on scheduled maintenance, status updates, and issues that may impact lab use
• Assist with arranging maintenance and service on equipment
• Escort service vendors for equipment maintenance and repairs
• Serve as EH&S point of contact and safety monitor
• Support and lead city/state inspections and audits
• Monitor systems, liquid nitrogen, and dry ice levels; place orders as needed
• Act as first responder for temperature alarm systems
• Manage and act of PoC for HVAC in office and lab spaces.
• Respond to urgent lab issues such as equipment failures, sample transfers, leaks or facility related issues
• General facilities duties such as lunch orders, stocking kitchen, and running dishwasher
• Provide back-up reception support as needed.
• Assist facilities team with event setup.
• Other tasks as may be assigned as needed

JOB SPECIFICATIONS:

• Prefer a Bachelor’s degree or a combination of equivalent education, training or experience.
• 2+ years of job experience working supporting lab operations in a biotech or pharmaceutical setting
• Ability to speak effectively and communicate to visitors in a professional manner. 
• Ability to work in a flexible, fast-changing environment and respond to needs quickly.
• Must be a team player who excels at customer service. 
• Will be detail oriented with strong attention to detail and have demonstrated experience prioritizing and organizing multiple tasks simultaneously. Punctuality and a positive, cheerful attitude is a must.
• Must be able to stand on your feet for long periods of time and lift 25+lbs

The base range for this role is $21 - $30 per hour. 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.

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ESSENTIAL JOB FUNCTIONS:

The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for the company’s products. This role ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development.

This position partners cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality to ensure robust safety oversight throughout the product lifecycle

Strategic Leadership

• Lead the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting.
• Lead safety strategy contributions to regulatory submissions, and lifecycle management strategies.
• Serve as safety lead on cross-functional governance committees (e.g., Safety Monitoring Committees).

Safety Surveillance & Signal Management

• Drive the development and continuous evolution of safety signal detection methodologies and product-specific signaling strategies. 
• Lead signal validation, prioritization, and assessment processes in alignment with global regulations; interpretation of safety signals and trends; communication of safety assessments (written and verbal) of safety risks in collaboration with other functional stakeholders.

Risk Management & Regulatory Strategy

• Provide strategic oversight for Risk Management Plans (RMPs), REMS (if applicable), and other risk minimization activities.
• Serve as safety representative in interactions with global regulatory authorities.
• Ensure inspection readiness and support health authority audits/inspections.

Aggregate Reporting & Safety Communications

• Oversee preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events).
• Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
• Provide strategic direction of safety content for key regulatory documents (e.g., DSURs, PSURs, IBs, protocols, RMPs) ensuring consistency and scientific rigor.

Cross-Functional Collaboration

• Partner with Clinical Development on safety monitoring strategies and DMC interactions.
• Collaborate with Biostatistics on integrated safety analyses.
• Provide safety expertise to Medical Affairs and Commercial teams for post-marketing surveillance, as needed.

Compliance & Quality

• Maintain oversight of safety vendors and CROs supporting surveillance activities.
• Contribute to SOP development and continuous improvement of PV systems and processes.
• Support inspection readiness activities, internal audits and external inspections.

Team Leadership

• Mentor and develop a high-performing Safety Sciences team.
• Foster a culture of scientific rigor, accountability, and patient focus.
• Manage departmental budget and resource planning.

JOB SPECIFICATIONS:

• PharmD or PhD in life sciences preferred.
• Advanced clinical or regulatory training highly desirable.
• 12+ years of experience in pharmacovigilance or drug safety.
• 5+ years in leadership roles within Safety Sciences, Signal Detection, or Safety Surveillance.
• Experience supporting global regulatory submissions and health authority interactions preferred.
• Strong background in oncology required.
• Experience in both clinical development and post-marketing safety preferred.
• Strong knowledge of signal detection methodologies and benefit-risk assessment.
• Experience in the principles and techniques of data analysis, proficient in the use of data analysis/visualization software.
• Working knowledge of industry standard safety databases, Regulatory databases, and other electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries.
• Proven experience authoring and reviewing aggregate safety reports.
• Demonstrate a deep understanding of and ensure compliance with current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
• Strategic thinker, a self-starter with strong scientific judgment.
• Executive presence and ability to influence cross-functional stakeholders.
• Excellent written and verbal communication skills.

The base range for a Senior Director is $274,000 - $330,000 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.

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ESSENTIAL JOB FUNCTIONS:

Join us as we embark on an exciting journey in transforming the treatment landscape of acute myeloid leukemia (AML). We are seeking a dynamic and experienced Associate Director / Director, Marketing Promotions to play a critical role in the development, approval, and execution of core promotional materials supporting KOMZIFTI (ziftomenib) in relapsed / refractory (R/R) NPM1-m AML.

Reporting to the Senior Director of Brand Strategy and Marketing, this role will lead the end-to-end execution of promotional tactics, including MLR submission and approval, sales force rollout, and digital marketing execution, while supporting broader brand strategy. The successful candidate will bring strong experience partnering with field teams, managing agencies, and working cross-functionally in a highly regulated oncology environment.

Responsibilities

Strategic Planning & Brand Management

• Lead development and execution of annual tactical plans in alignment with brand strategy. 
• Distill market research findings and sales trends into insights that direct promotional efforts.

Promotional Development & Execution

• Lead the development of core promotional materials, including print, digital, and field-facing assets, from concept through MLR review, approval, and final production for HCP and patient audiences.
• Own and manage the MLR process, ensuring compliant, high-quality materials are delivered on time.
• Drive effective rollout of approved promotional tactics to sales teams, in close collaboration with Sales, Sales Training, and Commercial Operations
• Ensure promotional materials effectively translate brand strategy into clear, actionable field tools.

Digital & Omnichannel Execution

• Lead execution of digital marketing tactics, including email, web, virtual engagement tools, and non-personal promotion.
• Manage media agency to optimize channel mix, implement tactics, measure performance, and optimize future tactics accordingly across HCP and patient audiences.
• Ensure digital tactics align with brand strategy and compliance requirements

Sales Force & Field Engagement

• Serve as a key marketing partner to the field organization, incorporating field insights into promotional development.
• Demonstrate proven experience translating brand strategy to field teams at sales meetings and field training initiatives.
• Act as a trusted point of contact for sales leadership, ensuring alignment between marketing execution and field needs.

Performance & Budget Management

• In collaboration with insights team, establish, integrate and track KPIs, performance metrics, and ROI for marketing activities.
• Monitor product performance and propose promotional adjustments based on market dynamics.
• Prepare and deliver clear, concise presentations to senior leadership, including updates on promotional plans, execution status, and performance insight
• Manage promotional budget.

Job Specifications:

• Bachelor’s degree in relevant field, advanced degree preferred.
• Minimum of 7 years of experience in biotech or pharmaceutical marketing, preferably in oncology or hematology
• Demonstrated experience leading promotional material development and MLR review
• Proven track record of working directly with sales and field teams
• Strong experience managing external agencies (creative, digital, production)
• Experience executing digital and omnichannel marketing tactics in a regulated environment
• Ability to work effectively in a highly cross-functional organization
• Strong communication and interpersonal skills, with comfort presenting to senior leadership
• Highly organized, detail-oriented, and able to manage multiple priorities
• Ability to travel up to 20% (domestic with limited international)
• Sales experience is a plus
• Product launch experience preferred
• Strong analytical skills; comfortable navigating complex and ambiguous environments
• Alliance partnership experience beneficial

The base range for this role at an Associate Director level is $180,000 - $215,000 and Director level would be $223,000 - $258,000 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.

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ESSENTIAL JOB FUNCTIONS:

• Leads the planning and execution of a complex, global clinical trial from start-up through close-out, in compliance with regulations/SOPs, within budget and timelines.
• Provides oversight and guidance to clinical operations personnel assigned to the clinical trial.
• Partners closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
• Establishes strong relationships with investigators and KOLs.
• Contributes to the development and review of key study documents including protocols, ICFs, monitoring plans, EDC specifications and statistical analysis plans.
• Contributes to the selection of vendors and CROs. Manages and oversees CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
• Develops, manages, and tracks clinical trial budgets, ensuring studies are delivered within approved financial parameters.
• Provides regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
• Proactively identifies operational risks and implements mitigation strategies to maintain timelines, quality, and compliance.
• Supports and facilitates execution of contracts, clinical trial agreements, and study budgets.
• Direct manager of approximately 1-2 direct reports.
• Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• 10+ years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to travel domestically and internationally as required.
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Experience setting up clinical trials outside of US and Europe is a plus.
• Field monitoring and/or clinical data management experience preferred.
• Proficiency with Microsoft Project

The base range for a Director is $228,000 - $252,000 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.

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ESSENTIAL JOB FUNCTIONS:

We are seeking a visionary executive to spearhead the formation and growth of a high-impact startup company focused on the discovery and development of menin inhibitors for diabetes and cardiometabolic indications. This is a high-growth leadership opportunity for an experienced leader ready to build a lean, science-driven organization from the ground up and accelerate the development of Caspian’s lead program, which is initially focused on generating clinical, proof-of-concept data in Type 1 diabetes.

In addition to serving as a senior executive leader, the successful candidate will oversee early clinical development of the company’s lead program, currently in IND-enabling studies, providing scientific, operational, and organizational leadership to ensure the seamless transition from research into early clinical development.

This role represents a unique opportunity to combine entrepreneurial leadership with scientific and clinical development stewardship. The successful candidate will play a central role in shaping both the company and its clinical pipeline; ultimately helping to deliver transformative therapies to patients with diabetes and cardiometabolic disease.

Strategic Leadership and Corporate Growth

• Serve as the principal executive leader responsible for establishing and growing Caspian into a high-performing biotechnology company.
• Work in close partnership with the CEO and leadership team at Kura Oncology to accelerate the transition of Caspian Therapeutics from an early-stage research organization to a clinically focused development company.
• Lead creation, translation, and execution of strategic business plans, from conceptualization through early commercialization planning.
• Be instrumental in developing both short- and long-term corporate strategy, including operational planning, resource allocation, and financial management.
• Establish and maintain key external relationships with the Caspian Therapeutic board of directors, investors, partners, advisors, investigators, CROs, and other stakeholders while maintaining awareness of the competitive and regulatory landscape.

Early Clinical Development Leadership

• Serve as the strategic leader for Early Clinical Development, providing guidance and oversight of integrated development plans as assets transition from discovery into clinical evaluation.
• Lead the design and execution of translational and early clinical strategies to enable efficient first-in-human and proof-of-concept studies.
• Ensure seamless transition of drug candidates from research to early clinical development through close collaboration with research, regulatory, CMC, and clinical operations functions.
• Define clinical development pathways, target product profiles, and early development milestones aligned with corporate objectives.

Operational Accountability

• As the organizational leader, be accountable for ensuring that activities within Early Clinical Development are executed within expected scope, budget, and timelines.
• Establish key milestones for development programs and provide direct leadership and organizational influence to ensure milestones are achieved or exceeded.
• Oversee clinical program planning, study design, vendor selection, and operational execution in partnership with internal and external teams.
• Closely monitor program performance and collaborate with strategic partners such as Kinexum to ensure efficient program delivery.
• Manage budgets and resources to support rapid, cost-effective advancement of the KO-7246 program and future pipeline assets.

Hands-On Organizational Leadership

• Take on a broad range of duties across the organization, helping to build core capabilities and infrastructure as the company scales.
• Drive cross-functional alignment between research, clinical, regulatory, and commercial planning teams.
• Provide mentorship and leadership to build a high-performing, science-driven organization.

JOB QUALIFICATIONS:

• Advanced scientific background: PhD or MD strongly preferred.
• Significant experience in early clinical development with a strong track record of advancing programs from discovery into the clinic.
• Requires the ability to influence and lead at the executive level.
• Proven ability to build, scale, and lead organizations in a biotechnology environment.
• Demonstrated experience overseeing development plans, budgets, timelines, and cross-functional execution.
• Strong ability to prioritize multiple demands and projects.
• Has a broad background with an emphasis in clinical development, project leadership and deep understanding of clinical operations.
• Spearhead strategic business planning and execution, driving measurable growth.
• Possesses a hands-on approach and a willingness to engage in all aspects of project execution.

The base range for a Vice President is $325,000 - $380,000 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.

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ESSENTIAL JOB FUNCTIONS:

The Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura’s oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications.   

To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives decisions and actions. 

• Contribute to the development and implementation of regulatory strategies for assigned projects.
• Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans, etc.). Lead and/or assist in authoring regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations.
• Lead and/or assist in the management of regulatory agency communications and interactions, preparation of briefing materials, coordination of rehearsals and minutes.
• Advise cross-functional development teams on regulatory requirements for development and approval pathways, including potential expedited pathways.
• Advise cross-functional teams and line management on regulatory risks, considerations, and strategies for program(s).
• Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and guidances.
• Provides strategic and technical regulatory input for key product development documents.
• Perform regulatory research and intelligence to continually inform project teams of the evolving regulatory landscape and to identify changes and potential strategic implications.

JOB SPECIFICATIONS:

• 10+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experience
• PharmD/MS preferred, or Bachelors degree in life science
• Experience supporting NDAs and working on post-approval products, drug labeling experience would be great
• Experience leading IND/CTA submissions for clinical trials
• Excellent written and spoken communication skills
• Attention to detail
• Strong organizational skills
• Strong interpersonal skills
• Solid working knowledge of drug development process
• Experience with planning and managing IND/CTA submissions.
• Experience working and interacting directly with FDA and/or other agencies
• Good understanding of US and EU regulatory landscape
• Hematology/Oncology or orphan-drug experience are preferred
• Demonstrated ability to think critically and analyze scientific information while paying close attention to detail
• The ability to influence and negotiate professionally at various levels within the project team and with external partners

The base range for this role at the Director level is $226,495 - $258,817 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.

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