Director, Clinical Development Scientist

Job Description Summary 

Collaborates with Clinical Development colleagues to efficiently design and effectively execute high quality clinical studies in close partnership with Clinical Operations. Your accountabilities include timely delivery of the protocol, clinical data review, and support of the appropriate interpretation and communication of data. As well as maintaining compliance with internal and external standards, mitigating risk and managing emerging clinical issues within the trial and being a contact for external investigators and internal study teams for questions relating to clinical/medical aspects of the protocol.

Your Responsibilities

  • In collaboration with the Medical Director, leads development and clinical/scientific execution of study protocols and amendments

  • Ensures appropriate data review, interpretation of study results, and reporting in collaboration with other functional groups.

  • Reviews and tracks emerging efficacy and safety data including adverse events and laboratory results, and keeps Medical Director informed of changes in the efficacy/safety as they occur and take action as appropriate

  • Conducts medical monitoring and addresses medical inquiries (only if Medically Qualified individual)

  • Works with the Medical Director to conduct routine safety reviews

  • Contributes to study documents, including ICF templates, eCRFs and SAE report forms

  • Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update reports, and clinical study reports

  • Supports and interfaces with Clinical Operations and study level project team throughout trial conduct

  • Collaborates with Medical Director to communicate study data results to colleagues, both internally and externally.

  • Assists with preparation of various presentations, including meeting abstracts, posters, oral presentations and advisory boards

  • Interprets, reports and prepares written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions

  • Assists with preparing responses to questions from Health Authorities and Ethics Committees

  • Prepares and may present scientific/clinical information at SIVs and internal and external meetings

  • Contributes to the clinical development strategy

  • Works closely with Quality to ensure flawless conduct of clinical aspects of trials

  • Ensures consistency across studies

  • Reviews medical literature and related new technologies

  • May support integrated document development for marketing authorization filing

  • May support preparation for the FDA Oncology Drug Advisory Committee and EU Oral Explanation

What is Required

  • Advanced medical degree preferred (not required)

  • Minimum of 10 years oncology clinical development experience

  • Significant experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports

  • In depth knowledge of regulatory guidelines and ICH/GCP

  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary

  • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams

Salary Range: 

$144,000 – $239,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus). 

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Remote

Sr Cloud Systems Administrator

Mirati is seeking an Sr. Cloud Systems Administrator who has extensive experience working with Microsoft's Azure platform and enterprise application services to support the IT leadership team in executing the roadmap for IT infrastructure and cloud operations. This role's primary focus is on ensuring technology resources are distributed, maintained, secured, configured, and effectively utilized across Mirati's growing network.

This is a technical role that requires hands-on knowledge of different areas within the cloud arena such as user management, authentication (e.g. Okta, Azure MFA), orchestrate VDIs Linux/Window/Images, cloud enterprise collaboration tools (Teams, SharePoint, OneDrive, Power Platform), cloud infrastructure architecture on AWS and Azure, scripting (PowerShell, bash, Azure cli), cloud and on-premise storage, backups, device management platforms (e.g Intune, Business Manager, Airwatch ), reporting, metric analysis, and familiarity with networking and wireless.

The ideal candidate will be passionate about information technology (IT) operations, providing reliable and secure infrastructure and networking platforms in support of Mirati's critical business solutions. They should have an excellent ability to communicate, organize, document, and solve problems using their in-depth understanding of information systems. They will also be able to use their technical experience and business acumen to maintain a trusted relationship with end-users and business partners, while enabling technical teams to deliver and maintain quality solutions aligned with Mirati's organizational goals.

Your Responsibilities

  • Troubleshoot and document deployment and system issues

  • Follow-up on alerts and notifications

  • Responsible for performance metrics, analysis, and uptime

  • Configure, secure, and maintain Infrastructure as a Service (IaaS)

  • Provide technical support to Mirati's end-users' through our ticketing system

  • Write and document code/instructions to automate system architectures

  • Working on custom special projects as assigned

  • Work with the Network Administrator to document, maintain and support networking efforts

  • Understands Azure platform and architecture, documents, and supports the underlying business processes, workflows, data and application platforms that depends on Microsoft and 3rd party services

  • Take ownership of issues, with a sense of urgency, and using sound judgment to resolve

  • SQL server maintenance and support

  • Firewall maintenance and support

  • Server documentation, installation, support, maintenance

  • Backup documentation and maintenance

  • Responsible for tracking licenses, metrics, and reporting

  • Engage peers in accordance with processes and procedures to document and contribute to solution/architecture designs

What is Required

  • Minimum 4 years' experience in a similar role

  • The ability to communicate to technical teams as well as non-technical resources.

  • Strong working knowledge of Azure's platform (M365, Exchange Online, SharePoint, Teams, Azure Active Directory, Power platform, SAML, Defender, SQL databases, Azure Storage, Virtual Network, VPN and Gateways, Powershell/Azure Cli); knowledge of Security and Compliance Center highly desired.

  • Strong knowledge of Azure/AWS infrastructure and architecture

  • Experience with the implementation, integration, management, and support of hybrid environments where SaaS, PaaS, and IaaS solutions, and virtualized and cloud-based infrastructure, are incorporated as required.

  • Strong working knowledge and proven working experience with the following: Windows, Linux, Unix, Storage, VDI, Active Directory, VMware, AWS, Azure, and hardware such as Dell and Cisco/Meraki.

  • Sound technical skills in networking (DNS, DHCP, remote user support, etc.) and experience with circuits, routers, switches, and ISP responsibilities and relationships.

  • Experience in the pharmaceutical industry is highly desirable.

  • Strong detail and organized documentation/technical writing

  • Strong verbal communication skills

  • Has a strong understanding and competency in IAM, resource monitoring and resource groups, mapping dependencies, and scripting

Pay Disclosure

Salary Range:

$80,000.00 – $135,000.00

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).

Total Rewards

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage.

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Hybrid

Associate Director, SEC Reporting & Technical Accounting

The Associate Director, SEC Reporting & Technical Accounting will oversee the SEC reporting function, technical accounting research and positions, and SOX compliance of Mirati Therapeutics, Inc. (the "Company"). This role will require a deep understanding of U.S. GAAP, SEC guidance and SOX 404 requirements, strong analytical skills, written and verbal communication skills, and an ability to develop relationships and work cross-functionally. The ideal candidate is highly motivated, detail-oriented, and can help identify and develop best processes and practices to help support growth of our team and the Company. 

Your Responsibilities

Plan, coordinate and execute all external, SEC financial reporting processes and initiatives, including related activities such as:

  • Prepare annual, quarterly and periodic reports (i.e., 10-K, 10-Q and 8-K), and coordinate reviews and lead meeting discussions over such documents with the Executive Leadership Team, Disclosure Committee, Audit Committee, and external auditors

  • Prepare the Company's annual proxy statement, including the related directors' and officers' questionnaires, ensuring compliance with all disclosure requirements and coordinating the annual meeting of shareholders

  • Prepare financial analyses and ad-hoc materials for audit committee and board of director meetings 

  • Perform technical accounting research around new accounting standards and complex accounting issues, and prepare technical memorandums to support the Company's positions

  • Key team member for first time commercial launch biotech company, evaluating accounting standards, disclosures, and our internal control environment for product sales, inventory, and gross-to-net considerations

  • Lead SOX 404b compliance efforts, by designing and implementing new internal controls as needed, monitoring ongoing performance and compliance of the Company's SOX procedures, ensuring appropriate documentation (narratives, risk assessments, testing results etc.), and identifying exceptions and conducting remediation efforts as needed. 

  • Coordinate directly with external auditors and facilitate quarterly review and year-end audit procedures

  • Proactively strive for process improvements to enhance financial reporting processes and implement best practices

  • Assist with monthly accounting close duties, as needed

  • Lead other special projects as required, and other duties to support the finance function

What is Required

  • 10+ years of accounting experience; combination of public accounting / life sciences industry experience is ideal.

  • CPA Required 

  • Experience with Workiva, Active Disclosure, or other financial reporting platform

  • Experience working in a SOX 404(b) compliant environment 

  • Substantial experience with and knowledge over U.S. GAAP, SEC guidance and SOX 404 requirements

  • Experience at a commercial biotechnology company is a plus

  • Strong time management and organizational skills 

  • High degree of attention to detail 

  • Strong written and verbal communication skills 

  • Ability to work independently and prioritize tasks 

#LI-Remote

Director, Medical Writing Operations

Job Description Summary

This leadership position will be responsible for providing comprehensive, operational expertise in formatting and editing medical writing (MW) deliverables, document quality control (QC), Data Disclosure, and vendor quality standards, partnering with internal and external groups to provide operational support and to ensure, compliance, and promote innovative solutions for reporting deliverables supporting the Clinical Development organization.

The role will strategize with MW leadership in building the framework to support integration of enterprise medical writing requirements such as clinical protocol writing, regulatory writing, as well as quality control of all clinical trial information that originates in the Clinical Development organization.

You will develop, implement, and maintain state-of-the-art medical writing processes and capabilities to improve quality and execution of Mirati's scientific documents. You will play a critical role in the success of Mirati's strategy to improve efficiencies and enable enhanced capabilities to delivering scientific documents. You will partner with multiple internal groups including Clinical, Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical Operations and Medical Affairs and work cross functionally with other leaders to ensure the medical writing standards meet business needs and objectives as well as regulatory standards.

Your Responsibilities

  • Lead internal team/external teams/consultants for delivery of high-quality documents formatted in accordance with applicable regulations and internal requirements

  • Lead internal team/external teams/consultants for quality control review of documents in accordance with applicable regulations and internal requirements

  • Support and lead efforts for Data disclosure/transparency and Data privacy (deidentification)

  • Establish and standardize Medical Writing practices/systems/tools

  • Identify, develop, and integrate new technologies into Medical Writing (i.e. semi-automatic generation of document component text, specifically involving "content reuse" in automated CSR and narrative writing, and redaction functionality)

  • Optimize and lead medical writing strategies, processes and procedures

  • Provide training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.

  • Ensure appropriate communication and involvement across functions, internal/stakeholders to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies

  • Establish medical writing practices and efficient processes for submissions globally

  • Monitor benchmarks with industry peers and across other industries to establish and update best practices and KPIs

  • Recognize and implement efficiencies identified through process improvements

What is Required

  • Master's Degree in a scientific discipline. Doctorate degree preferred.

  • At least 12 years of experience in pharmaceutical or biotech industry in medical/regulatory writing operations including at least 4 years of experience leading teams

  • Strong background showing progressive MW operations, experience, including staff management

  • Previous outsourcing management experience preferred

  • Ability to understand and utilize new technology and new systems in medical writing

  • Experience with ICH, eCTD, submission requirements for clinical/research reports, along with an understanding of electronic submissions requirements

  • Strong written/verbal communication skills, detail-oriented nature

  • Excellent leadership and influencing skills

  • Demonstrated project management skills

  • Ability to provide direction with cross-functional teams in a matrixed team environment

  • Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)

Salary Range: 
$200,000 – $266,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus). 

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision
  • Company provided life insurance and disability coverage
  • 401(k) retirement plan with a 6% company match and immediate vesting
  • Employee Stock Purchase Plan with a 15% discount
  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Remote

Medical Director

Job Description Summary

Mirati is looking for a talented Medical Director to join the Clinical team. The successful candidate will have a passion for novel science, an affinity for strategic thinking, looking beyond the day-to-day execution, and will have a track record of keeping clinical programs on track and hitting milestones. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the program to regulatory standards and procedures and will be graded according to the level of experience of the successful candidate.

Your Responsibilities

  • Clinical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements.

  • Help identify global study sites and foster relationships with study investigators

  • As the primary medical monitor for assigned study(ies), be the first point of contact with sites; answer site questions about eligibility, enrollment; safety and patient management

  • Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues

  • Production of clinical documents required for the conduct of clinical studies, such as clinical protocols (and amendments as needed), informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices

  • Preparation of abstracts and posters for scientific meetings

  • Preparation of slides/ presentation at internal and external meetings, such as team meetings, Advisory Boards and Board of Director Meetings

  • Lead ongoing data interpretation to understand safety and efficacy profile of the investigational drug

  • Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages

  • Present aspects of clinical program at Site Initiation Visits, Investigator's Meetings and scientific conferences

  • Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas

  • Assist in case report form (CRF) development and data analysis plans

  • Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents

  • Perform in data cleaning and clinical study report review

  • Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study reference manuals

  • Assist in generation and update of Clinical Development Plan (CDP)

  • Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

What is Required

  • Medical Doctor (M.D.), either with Board Certification in Medical Oncology/ Hematology Oncology or Internal Medicine

  • 5+ years of clinical development experience in the pharmaceutical or biotechnology industries with at least 2 years involvement in oncology drug development

  • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.

  • Phase IIII oncology clinical trial experience preferred.

  • Working knowledge of the IND/NDA process preferred.

  • In-depth knowledge of GCP/ICH guidelines preferred.

  • Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.

  • Available for ~ 25% travel, including overnight stays.

  • Strong written and verbal communication skills required.

  • Ability to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities.

  • Leadership skills including a collaborative and team-oriented approach.

  • Good organizational, time management and interpersonal skills.

  • Demonstrated excellence in management skills, with track record of successfully managing multiple projects, trials, and priorities.

  • Ability to work well with global, multi-disciplinary teams.

Salary Range:  

$214,000 – $297,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus). 

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Remote

Director, Compliance

The Director, Compliance will assist with the development and implementation of a healthcare compliance program at Mirati, including being responsible for the implementation of systems, programs, processes, and practices to ensure that the Company is in compliance with legal and regulatory requirements and its policies. The Director, Compliance will provide a broad range of compliance support throughout Mirati's organization; partnering with the business to sustain Mirati's ethical and compliant culture and develop practical ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical company.

Your Responsibilities

  • Independently drive the development, implementation, and management of the compliance program, including policy, process, training, communication, auditing, monitoring, and investigations

  • Lead and manage all compliance operations activities including providing compliance oversight and participating, as required, in review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.

  • Develop and be responsible for oversight of the company's compliance auditing and monitoring program; including:

    • Assessing organizational compliance risk in creating and updating a risk-based audit and monitoring plan. Partnering with the business to address detected noncompliance including recommending and taking corrective actions when needed

    • Track and report results of compliance investigations and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed. Interpret findings/trends and carry out corrective action and retraining as needed

  • Develop and oversee a comprehensive compliance training program and communication strategy to U.S. employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company's compliance program.

  • Create and lead the transparency reporting program, including developing, reviewing, and submitting reports related to federal and state transparency ("Sunshine") laws.

  • Monitor the business developments and industry compliance best practices to evolve the compliance program through ensuring appropriate practices, processes, systems and tools are in place and maintained to support the business at all times.

  • Be an ambassador for communication around key compliance topics, resources, and special initiatives

What is Required

  • Bachelor's degree and 10 years' experience or any combination of education and experience providing equivalent background.

  • Certification in Healthcare Compliance (CHC) preferred.

  • Working knowledge and previous experience in a compliance operations or project management position desired

  • Excellent interpersonal, communication and written skills, proven ability to work independently with a wide range of stakeholders.

  • Strong presentation and training skills and ability to work independently.

  • Interact with employees and manage vendors.

  • Up to 20% travel may be required.

Pay Disclosure

Salary Range:

$177,000.00 – $236,000.00

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).

Total Rewards

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Remote

Sr Manager, FP&A – Supporting Clinical Operations

The Sr Manager, FP&A will be a Finance Business Partner between Finance and the Clinical Operations Teams. This position will drive financial planning and forecasting by working cross-functionally to support our clinical studies and major business initiatives. The role will focus on the analytics that support budgets, forecasting, financial reporting and program management. The Sr Manager, FP&A will be a hands-on resource to senior management, clinical operations department heads and program leads.

Your Responsibilities

  • Develop and coordinate financial budgets and forecasts for the organization.

  • Participate in the budgeting/forecasting process; includes owning financial reporting in partnership with Program Team Leaders, Program Team Members and Clinical Operations Department Heads. Thus, ensuring financial information (budget vs actual) and other key performance indicators are provided on a monthly basis in order to effectively manage the active programs and the business as a whole.

  • Ensure all key topics are raised proactively and aligned with stakeholders to minimize surprises.

  • Prepare monthly reporting packages that include full financial statements, key performance indicators, key business trends, actual vs budget/forecast variances and comprehensive explanations of key differences for assigned functional areas.

  • Work closely with Clinical Operations Department Heads to perform budget re-forecasting on an as required basis.

  • Work closely with Clinical Operations Department Heads to develop and review customized financial reporting to support clinical trials and associated activities.

  • Develop financial models and productivity tools to help make responsible financial decisions. Recommend enhancements to the financial planning and budgeting process and system that effectively generate program and activity-based reporting to meet internal business and SEC reporting requirements.

  • Provide accounting support in connection with the monthly close process and coordinate with Accounting to drive Balance Sheet and P&L accuracy and control.

  • Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

What is Required

  • Bachelor's degree in Finance, Accounting, Business Administration or science-related field (Master's Degree or CPA Preferred).

  • 7+ years of relevant experience.

  • Proven experience utilizing advanced Excel skills to interpret large amounts of data.

  • Financial Planning systems knowledge; Adaptive Insights preferred.

  • Experience providing financial support in the biotechnology/pharmaceutical industries, specifically supporting clinical operations

  • Understanding of GAAP and key accounting principles.

  • Excellent interpersonal skills, along with the ability to work effectively with multiple functional areas in a collaborative, team environment.

  • Strong verbal and written communication skills.

  • Ability to thrive in a fast-paced ever-changing environment.

  • Alignment with Mirati's culture and values.

Pay Disclosure

Salary Range:

$140,000 – $185,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).

Total Rewards

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Remote

Sr Paralegal, IP

Mirati is seeking an experienced paralegal to assist with our day-to-day intellectual property and contracting needs. The ideal candidate should have significant experience assisting in the generation and filing of patent and trademark applications and related documents, docketing and facilitating patent and trademark workflow, and working with in-house and outside IP counsel to develop high-quality patents and trademarks. The ideal candidate should also have significant experience drafting, negotiating, and managing a variety of agreements for pharmaceutical and life sciences companies, including clinical trial agreements, non-disclosure agreements, master services agreements and consulting agreements. The successful candidate must be able to work independently to draft, revise and negotiate agreements, with a flexible and collaborative approach.

Your Responsibilities

  • Docket patent- and trademark-related correspondence. Generate docket reports using docketing software. Review docket reports to ensure timely provision of instructions to US and foreign agents.

  • Interact with in-house IP counsel, outside US and foreign patent counsel, and partners' patent counsel to facilitate smooth, accurate and prompt handling of patent and trademark matters.

  • Assist in drafting/assembly/execution of patent applications and patent prosecution documents, including formal papers (assignments, declarations).

  • Draft, review and negotiate day-to-day contracts, including non-disclosure agreements, master service agreements, consulting agreements, clinical trial agreements and other clinical documents, independently and with limited supervision.

  • Manage contract negotiations to conclude agreements as efficiently as possible while meeting client needs and safeguarding Mirati's interests.

  • Review and comment on IP terms in a broad array of agreements.

  • Address legal concerns of business groups across the company and coordinate cross-functionally with business groups including finance/accounting, clinical science, medical affairs and research.

  • Complete projects and special assignments, as needed.

Pay Disclosure

Salary Range:

$110,000.00 – $157,000.00

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).

Total Rewards

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

Associate Director, Biostatistics

Job Description Summary

The Associate Director, Biostatistics will provide statistical expertise to support Medical Affairs, Health Economics and Outcomes Research, and Real World Evidence generation. Responsibilities includes recommendation of study design, endpoint selection, perform statistical analysis, provide input to proposed protocol concepts, contribute to publication development and reviews, and participate in working groups across clinical development through commercialization. In this role, the associate director ensures all aspects of the projects meet the statistical rigors and standards, regulatory requirements, and quality deliverables are met and are aligned with clinical development and commercialization goals. The director will oversee external vendors and interprets/presents the analysis results in easily understandable terms to non-statistical audience.

Your Responsibilities

  • Provide statistical expertise to Medical Affairs and HEOR to ensure appropriate statistical principles are applied and the interpretation of the results are statistically valid

  • Partner with team members from Biometrics, Clinical Development, HEOR/RWE, Medical affairs to achieve team project goals

  • Provide statistical input to study concepts and proposals from investigators (Investigator Sponsor Trials) and ensure strategic alignment with the product lifecycle

  • Participate in the publication planning and perform exploratory analysis in support of the publication plans

  • Partner with external vendors and/or independently perform statistical modeling and analysis of patient reported outcomes data using accepted statistical methodologies and/or other advanced statistical approaches in support of value demonstration to patients and other stakeholders

  • Review and provide statistical input to protocols, reports, value/reimbursement dossiers, and other ad hoc data requests

  • Partner with cross functional team to develop and implement an effective plan to leverage RWE, where applicable

  • In collaboration with team members, select vendors to assist on projects for Medical Affairs and HEOR/RWE as necessary

  • Manage vendors by providing proper oversight to ensure quality deliverables and on-time delivery

  • Provide computational and statistical advice on complex analytic issues supporting RWE projects and be able to work in an autonomous manner; participate in disease specific RWE meetings as needed

What is Required

  • PhD or MS in statistics, biostatistics, or closely related discipline; a minimum of 5 (for PhD) or 8 (for MS) years of experience for Ph.D. and 8 years of working in Medical Affairs, HEOR, and/or RWE

  • Oncology experience preferred

  • Strong programming skills in SAS and/or R and other statistical analysis software

  • Experienced in statistical modeling and simulations

  • Experienced with advanced inferential statistics (including and not limited to longitudinal data analysis, missing data methods, cost-effectiveness analysis, meta-analysis, Bayesian methods), real-world data analysis methods such as propensity scores, machine learning, and related techniques

  • Prior exposure working with value/reimbursement dossiers and interactions with regulatory agencies or HTAs, a plus

Salary Range: 
$181,000 – $210,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus). 

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

#LI-Remote

Senior Medical Writer

Job Description Summary

We are looking for a Sr. Medical Writer to develop high-quality, scientifically accurate medical communications materials for a variety of audiences. You will be responsible for clinical protocol writing and regulatory writing. You will partner with multiple internal groups including Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, and Clinical Operations, and work cross functionally to ensure the medical writing standards meet business needs and objectives as well as regulatory standards.

Your Responsibilities

  • Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator's brochures, and safety reports

  • Perform copy editing for grammar, punctuation, style, and internal consistency

  • Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management

  • Administer QC checks to ensure documents comply with FDA guidelines

  • Help develop and manage medical writing processes, SOPs, and templates for key documents

  • Help manage the functional review of study documents produced by contract writers

  • Keep abreast of professional information and technology through literature, symposia, and conferences

  • Participate in departmental and cross-departmental initiatives. Provide innovation and be a resource for improving departmental processes. Provide expertise and guidance on document design and principles of good medical writing to department and product teams

What is Required

  • Bachelor's degree, preferably in a physical science, life science, or health-related field (biology, chemistry, nursing, etc). Advanced degree (Masters, Doctorate) is a plus but not required

  • 5+ years of directly related experience in a pharmaceutical company or CRO environment writing protocols and clinical development documents as well as supporting documents for regulatory submission to health authorities, US and/or EU

  • Minimum of 2 years of experience in the oncology medical writing

  • Direct experience writing protocols from the study design phase

  • Experience with SharePoint and Veeva a plus

Salary Range: 
$80,000 – $125,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus). 

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

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