Careers

MEI Pharma's staff is a team of friendly, dedicated, experienced and collaborative professionals committed to the hard work that supports our company's aggressive goals and to the workplace values that promote our success.

Our workplace values include:

  • Shared commitment to excellence and collaboration across functions
  • Personal accountability for consistent superior performance
  • Fiscal discipline applied wisely in the use of resources
  • Mutual trust and respect for individual differences
  • Dedication to developing novel therapies for our patients

 

 

 

Open Positions

Associate Director, Financial Planning & Analysis

Job Summary: The Associate Director, Financial Planning & Analysis will report to the Executive Director, Finance and will work closely with other members of MEI Pharma’s Finance and Accounting team. This position will manage short-term and long-term financial planning including annual budgeting, long- term forecasting and modeling, as well as other areas of finance and analysis. The Associate Director, Financial Planning & Analysis plays a key role working with various functional leaders of the company, specifically within the Clinical department and the alliance management team. This position does not manage any staff currently, therefore it is a hands-on management role.

Role & Responsibilities:

  • Plan and coordinate the annual budget process, long-term forecast, periodic re-forecasts and on-going projections.
  • Provide regular reporting and variance analyses to R&D function and cost center managers to enable decision making and alignment to company objectives.
  • Provide budget versus actual analyses to alliance partners with whom we have collaborative cost-sharing arrangements.
  • Work closely with clinical operations in order to develop budgeting and long-term forecasting related to clinical trials and related expenditures and collaborative arrangements with alliance partners.
  • Prepare, review and analyze financial reports, presenting operating results and budget variations for Executive Management.
  • Forecast and manage cash flow and assist in managing cash investments to maintain appropriate liquidity for the company.
  • Provide financial analysis and presentations for Audit Committee, Board of Directors, press releases, alliance partners, and investor packages.
  • This is a hands-on management position.
  • Identify and implement process development and improvements relating to budgeting, forecasting, period close process, ERP implementation, and financial reporting.
  • Participate in other ad hoc projects, roles, and workload sharing between Finance and Accounting as appropriate.
  • Other related duties, as assigned.

Qualifications:

  • Strong communication skills, ability to effectively interact with others at all levels– within and outside of finance. Ability to tailor communication to the audience to achieve desire results.
  • Self-starter with the demonstrated ability to work in a fast-paced atmosphere with minimal supervision.

Job Requirements and Education:

  • Bachelor’s degree in Finance/Accounting, CPA/MBA preferred.
  • 7+ years of experience in accounting, financial reporting/analysis.
  • 2 + years of experience as FP&A manager.
  • Biotechnology or pharmaceutical industry experience preferred.
  • Experience with building financial models for clinical trials a strong plus.
  • Highly proficient in Microsoft Excel, with experience building models.
  • Experience utilizing enterprise-grade, commercial ERP systems and reporting software; Netsuite and Adaptive experience a plus.
  • Reputation for gathering, analyzing, and interpreting information for completeness and accuracy; excellent attention to detail; excellent organizational skills.
  • Experience with FP&A Planning systems preferred.
  • Working knowledge of Generally Accepted Accounting Principles (US GAAP).

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lifting up to 25 lbs.
  • Routine office duties including computer keyboard use.
  • Vision requirements include close vision and ability to focus.
  • Noise conditions range from quiet to moderate.
Apply Here

Associate Director, Regulatory Affairs

Job Summary: Reporting to the Executive Director of Regulatory Affairs, the successful candidate will contribute to the development and execution of successful regulatory strategy to support investigational products for new or active US and global oncology clinical studies.  This candidate will also represent the regulatory affairs group as part of cross-functional teams to provide regulatory support and guidance.  This candidate will coordinate, prepare and support routine and complex regulatory submissions.

 Role & Responsibilities:

  • Support and execute on regulatory strategies for assigned programs in the areas of Oncology and Hematology drug development and lifecycle management
  • Provide regulatory strategic input in collaboration with Regulatory senior management and through analysis of regulatory guidance and drug approvals in the competitive space
  • Provide strategic guidance to teams on the regulatory requirements and risk to support MEI’s clinical development programs including preparation and maintenance of IND and IMPD filings
  • Support meetings with regulatory health authorities
  • In collaboration with teams, assess/manage critical analyses of data to independently develop interpretations and conclusions
  • Support interdepartmental teams in the authoring of high-quality regulatory communications such as regulatory meeting requests, briefing packages, and responses to regulatory health authority comments/queries and manage global regulatory interactions including review of clinical trial applications and other regulatory documents/submissions
  • Serve as Regulatory lead in cross-functional collaborative team settings for clinical studies and for regulatory projects such as complex submissions
  • Ensure compliance with regulatory procedures and work practices
  • Identify, draft and review Regulatory Affairs SOPs, as necessary, and develop a working knowledge of internal SOPs

Qualifications:

  • Highly ethical with uncompromising personal integrity.
  • Critical thinker and creative problem solver with excellent organizational skills.
  • Ability to perform in a fast-paced, dynamic environment.
  • Excellent written, verbal, influential, collaborative and interpersonal skills.
  • Can deal calmly and objectively with complexity and time pressures.
  • Team player

Job Requirements and Education:

  • Bachelor’s degree, in a scientific discipline preferred
  • At least 8 years’ experience with small molecules in Regulatory Affairs within a pharma, biopharma or biotechnology company – oncology desired
  • Experience in Phases 1-3 and commercial product lifecycle
  • Experience in preparation and submissions of INDs, IMPDs, NDA
  • Understanding of relevant regulations and guidelines, including ICH, FDA and EMA for development of small molecule products
  • Knowledge of GMP, GLP, GCP
  • Experience in ability to diplomatically lead team discussions
  • Excellent communicator, orally and written
  • Strong negotiating and problem-solving skills
  • Proven ability to deliver results within business defined timeframes

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Director, Biostatistical Programming

Job Summary: Reporting to the Executive Director, Biometrics, the Director, Biostatistical Programming at MEI Pharma will serve as the Head of the Biostatistical Programming team. This individual will provide strategic input in Biometrics planning, be accountable for the development of clinical study related deliverables and timelines, lead global regulatory submission activities, as well as oversee vendors' programming deliverables.

 Role & Responsibilities:

  • Lead statistical programming function to support clinical development
  • Develop and supervise statistical programming resources
  • Lead programming activities to support global regulatory submissions
  • Maintain documentation to track programming activities and timelines
  • Develop and maintain SAS programming infrastructure and process to ensure the quality and compliance in statistical programming deliverables
  • Establish programming and QC processes, create related SOPs
  • Provide training on departmental policies and programming standards
  • Create SAS macros/applications to streamline processes
  • Lead development of SDTM and ADaM specification and datasets for clinical studies and integrated analyses
  • Monitor, analyze and report clinical trial data and generate outputs to support planned or ad-hoc requests
  • Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing pivotal studies
  • Participate in FSP vendor selections, oversee vendors' activities and review vendors' deliverables to ensure quality
  • Provide technical leadership and guidance for programming team and vendors

Qualifications:

  • Proven ability to manage CRO relationships and oversees programmed deliverables
  • Advanced skills in SAS programming and statistical reporting
  • In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements
  • Advanced knowledge with FDA and ICH regulations and guidelines, medical terminology and clinical trial methodologies
  • Good written and verbal communication skills
  • Be able to work productively in a fast-paced collaborative environment

Job Requirements and Education:

  • Master’s degree in statistics, computer science or a related field with at least 12 years of SAS programming experience in the pharmaceutical or biotech industry
  • Prior leadership and/or management experience
  • Leadership role in successful global regulatory submissions
  • Employment type

    Full time 

    ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Director, Clinical Data Management

Job Summary:

MEI Pharma, Inc. is seeking an experienced, highly motivated professional as the Head of Clinical Data Management function. This person will be an integral member of the Biometrics team whose work enables the company to meet defined goals for the clinical development programs. The Head of Clinical Data Management collaborates with other functional peer groups at various management levels and senior management to ensure proper conduct and timely completion of all projects, as applicable. The successful candidate will report to the Head of Biometrics.

Role & Responsibilities:

  • Lead a team of high performing clinical data managers to meet business objectives
  • Oversee all data management activities and deliverables
  • Act as a core member of the study team and provides CRO oversight for end-to-end Data Management activities, and monitor DM deliverables
  • Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews)
  • Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
  • Support the development of the clinical components of regulatory submissions
  • Perform data review, and lead internal cross-functional team review on clinical data on an ongoing basis per Data Review Plan
  • Develop Vendor Management Plans, monitor vendors’ quality performance based on pre-defined quantitative or qualitative metrics
  • Manage competing for data management priorities across multiple studies
  • Develop and maintain appropriate data management SOPs

Qualifications:

  • Strong working knowledge of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations
  • Excellent communication skills (oral and written) and interpersonal skills
  • Strong analytical and problem-solving skills

Job Requirements and Education:

  • Bachelor’s degree in Life Science, mathematics, or health-related fields
  • Minimum of 12 years of data management experience in the pharmaceutical/biotech/CRO industry
  • At least 2 years of oncology therapeutic area experience
  • Experience supporting eCTD submissions required

Employment type

Full time

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and the ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Director, Market Insights & Analytics

Job Summary:

The Director, Market Insights & Analytics reports to the Senior Vice President, Marketing. This position will be responsible for designing, developing, and executing the insights and analytics that will inform the US commercialization strategies in support of the zandelisib launch in Follicular Lymphoma. The role will work closely with cross-functional partners in marketing, market access, medical affairs, clinical development, manufacturing, and our alliance partner to leverage data and analytics to drive strategic and execute excellence of the product through its’ lifecycle. The Director, Marketing Insights & Analytics position will be an important leader to support the mission to develop and deliver life-changing therapies to people living with cancer.

 

 Role & Responsibilities:

  • Works closely with the leadership team to develop insights-driven commercialization strategies that result in the successful commercialization of MEI Pharma’s pipeline
  • Develops a deep understanding of markets or interest by synthesizing information and insights spanning different sources and types of data
  • Leads the integration of insight and analysis from a variety of sources (primary market research, CI, secondary data) to provide actionable opportunities/ strategies
  • Primary Market Research: Manages market research design (Qualitative/Quantitative) and execution (including vendor/project management) with minimal supervision. Generates and effectively communicates relevant/ actionable insights based on interpretation of results
  • Secondary Data: Generates insights from real-world secondary data sources for relevant disease states. Pulls data from syndicated data sources understands data strengths/ weaknesses and provides conclusions/ recommendations to commercial teams
  • Competitive Intelligence: Leads the generation of competitive analysis (congress coverage, alerts, company reports, etc.), ensuring implications are reflected in the brand strategy, the forecast, and communicated to key stakeholders. Develops a robust CI plan, aligned to key intelligence topics and key intelligence questions, to monitor the competitive environment and emerging data to inform clinical, regulatory, and commercial strategies
  • Collaborates with and is the primary liaison for insights associated with the markets of interest across functional partners
  • Forecasting: Leads long-term forecast model development, gains alignment on key assumptions within the Commercial team and effectively communicates forecast implications to senior management and key stakeholders
  • Anticipates business needs for research and additional insight planning. Accountable for management of budget and contractor/consultant relationships associated with analytics and insights plan
  • Ensures compliance with all applicable policies and regulations
  • Other related duties as assigned

 

Qualifications:

  • Ability to combine primary data sources and secondary market research insights to support sales and marketing strategies and forecasting
  • Proven analytical and problem-solving skills. Strong PC and software skills including Microsoft Office Suite
  • Exceptional organizational, time, and task management skills. Ability to prioritize critical tasks and maintain high degree of accuracy amid competing deadlines
  • Effective communication and presentation skills

 

Job Requirements and Education:

  • B.S. in mathematics, statistics, or other analytics-related degree preferred
  • 10 years of experience in pharmaceutical commercial data, and analytics
  • Knowledge of pharmaceutical data sources and their application to support business decisions
  • Experience using limited data to gain actionable insights
  • Hematology/oncology experience required
  • Ability to travel occasionally (<20%)
  • Based at MEI headquarter in San Diego
Apply Here

Director, Quality Management Systems

Job Summary: The Director of Quality Management Systems (QMS) will report to the Vice President, Quality.  The Director QMS, will be responsible for the overall development, implementation and continuous improvement of MEI Pharma’s GXP QMS. Primary responsibilities include the execution and oversight of the GMP Product Complaints, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation, CAPA, Risk Management, Vendor Management, and GXP Computer System Validation processes at MEI Pharma. The Director will lead the implementation and on-going improvement of GxP QMS processes, by initiating and executing Quality improvement initiatives. The role will be responsible for the implementation of new electronic systems for key QMS processes. The Director will address gaps associated with the current QMS processes as part of continuous improvement and ensuring future clinical and commercial manufacturing and supply chain needs are met. This position requires experience developing, implementing, and managing Quality Management Systems; and the ability to perform at high levels in a fast-paced, dynamic environment.   

 Role & Responsibilities:

  • Oversee the execution of the Deviation, CAPA, Change Control, Product Complaints, Management Review, Annual Product Quality Review, Risk Management, Vendor Management, and GxP Computer System Validation.
  • Implement and improve GxP processes.
  • Increase efficiencies in planning, executing and documenting QMS processes through the implementation of electronic systems.
  • Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes.
  • Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings.
  • Implement risk-based approaches to QMS processes.
  • Assist the MEI Pharma Quality management team to ensure that QMS processes comply with applicable regulatory standards, regulations and guidelines.
  • Manage resources to achieve company, department and functional area goals and objectives.

Qualifications:

  • Experience in an outsourced manufacturing environment.
  • Experience in validation of computerized systems.
  • Experience with Phase 3 and/or commercial bio-pharm manufacturing.
  • Must have excellent verbal, written, interpersonal, and organizational and communication skills.
  • Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
  • Ability to work independently.
  • Ability to manage tasks with competing priorities or deadlines.
  • Successful experience in fast-paced entrepreneurial environment.
  • This is an office-based San Diego position with a potential for travel as needed.

Job Requirements and Education:

  • BA or BS degree in a scientific discipline or comparable experience.  
  • At least 10 years of experience in Quality Assurance at an operational level supporting manufacturing, quality control in a pharmaceutical or biotech environment.
  • Minimum of five (5) years of managing Quality Management Systems.

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate

 

Apply Here

Executive Assistant

Job Summary: Reporting to the CEO, the Executive Assistant will play a critical role in providing superior support to the CEO, CFO, and VP, HR. The Executive Assistant also will be responsible for overseeing general office functions and vendor management. 

 Role & Responsibilities:

  • Support to CEO, CFO, and VP HR
    • Calendar management: scheduling of internal and external meetings. Liaison with key external stakeholders  
    • Meeting management to include conference/video calls, meetings, and logistics, etc.
    • Provide the Board of Directors meetings and event support (planning & scheduling meetings, material dissemination, travel, etc.)
    • Manage contacts
    • Manage travel arrangements/logistics including documentation and timely processing expense reimbursements
    • Prepare and review written materials and correspondence including agendas, meeting minutes, writing memos, and first-level response for email and written correspondence, including 3rd party interactions
    • Assist with creation/modification of presentations, spreadsheets, and other documents
    • Perform other related duties as assigned
  • Office Management
    • Facilities management (landlord interactions, move management, security/safety, etc.)
    • Logistics (shipments & mailing, supplies, and organizing documents, reproduction, etc., as needed.)
    • Provide employee wellness (planning celebrations, hosting employee visits, maintaining pantry, etc.) activities and support
    • Manage and schedule internal and external interviews and meetings including calendars, conference rooms, catering, videoconferences, CDA compliance, and records, etc.)
    • Maintain Company shared drives for administrative files 

Qualifications:

  • Highly organized with strong attention to detail; strong project management and prioritization skills
  • Flexibility to respond in a variety of time periods/across multiple time zones
  • History of planning and executing, including back-up and contingency plans
  • Customer service focus on a courteous, discreet, and professional demeanor in all situations
  • ‘Do what it takes’/ hands-on approach
  • Prior experience demonstrating self-directed enthusiasm to thrive in a dynamic, fast-paced "start-up" environment
  • Advanced MS Office (Word, Excel, Outlook, PowerPoint) experience as well as cloud-based applications (Box; Dropbox; BoardVantage)
  • Excellent written and verbal communication skills
  • Excellent time management and prioritization skills with a history of success multi-tasking projects/tasks
  • Outstanding flexibility, excellent interpersonal skills, history of working well with all levels of internal staff and outside parties, including vendors, contractors, and partners
  • Work history of creating solutions and results-oriented focus
  • Trains and manages administrative assistant and receptionist as needed

Job Requirements and Education:

  • Bachelor’s degree plus 8+ years of a combination of office management and administrative support experience, including at least 4+ years as an Executive Assistant to C-level executives in a highly collaborative and team-driven environment, preferably in a Biotech/ Pharma industry
  • Prior experience in life sciences

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Medical Science Liaison- US (Midwest)

Job Summary: Reporting to the Director of Medical Affairs, the Medical Science Liaison (MSL) is a field-based member of Medical Affairs who develops and enhances professional relationships with medical thought leaders, investigators, and key medical organizations.  The MSL identifies collaborative opportunities with key thought leaders and provides medical information through medical/scientific discussions and presentations in a balanced, non-promotional manner.  This is research-focused and a highly visible role within the MEI team. It is a challenging position in a fast-paced setting that requires a highly motivated, self-starter.  The role is performed in accordance with all applicable legal, regulatory and professional guidelines. 

 Role & Responsibilities:

  • Identifies specific oncology Key Opinion Leaders (KOLs), establishes and maintains scientific relationships with KOLs, and identifies opportunities for collaborations 
  • The MSL ensures the appropriate dissemination of clinical and scientific information regarding MEI's oncology pipeline compounds
  • Collaborates with the in-house Clinical Operations and Clinical Development teams to enhance patient enrollment in company-sponsored clinical trials, identify appropriate clinical trial sites, and provide clinical and scientific updates to investigators in ongoing studies
  • Contributes to regional and national/international congress strategies
  • Provides scientific and medical support at national/international congresses and regional medical meetings
  • Develops succinct summaries of key information learned through medical meeting attendance and field activities
  • Contributes to the planning and execution of scientific panels and meetings
  • Provides timely feedback and information on emerging clinical trends to internal staff
  • Facilitates and manages investigator- initiated studies
  • Contributes to publication planning and other medical communications activities
  • Ensures all activities are compliant with MEI’s company policies

Qualifications:

  • Flexibility to adapt to changing priorities
  • Respectful, accountable and collaborative
  • Ability and desire to work in a collaborative team
  • Excellent time management skills to balance multiple responsibilities and to meet deadlines
  • A solid professional reputation for interacting productively with thought leaders in the field
  • Able to spend a significant amount of time in the field

Job Requirements and Education:

  • Advanced scientific degree (PhD, PharmD, DSc) with at least 3 years of Hematology/Oncology MSL experience
  • Lymphoma experience is strongly preferred
  • Excellent presentation and communication skills
  • Strong understanding of clinical and scientific data
  • An understanding of the oncology drug development process
  • Ability to create materials such as reports and presentations for internal and external groups
  • Approximately 50-60% travel is required; overnight travel required as needed
  • Must possess a valid driver’s license and a good driving record

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate

 

Apply Here

Quality Assurance Manager

Job Summary: Reporting to the Director of Quality Assurance, the Quality Assurance Manager is responsible for quality oversight of daily operational activities at contract manufacturing, packaging/labeling and testing facilities for products and services that support clinical studies (phase I through phase III) and products that meet commercial requirements. The position will provide quality guidance and work with MEI internal departments to ensure all applicable regulatory requirements and company quality management system requirements are met.   

Role & Responsibilities:

  • Primary QA contact with external vendors that manufacture, test, package, label, and/or distribute product or provide services for GMP activities.  Responsible for quality approval of vendor generated documents – e.g., analytical methods, method validation protocols/reports, process validation protocols and reports, specifications, master batch/packaging records, label proofs, deviations, CAPA and change controls.
  • Quality reviewer of executed batch/packaging records, product testing records (in-process, release, and stability), deviations, investigations, stability protocols/reports, method/process validation documentation, reference standard requalification documentation, certificates of analysis, certificates of compliance.  Ensures all materials are manufactured in compliance with applicable regulations and MEI regulatory submissions.
  • Dispositions drug substance\drug product batches and work-in-process materials for use in downstream manufacturing operations, dispositions final products for clinical or commercial use. Provides approval for shipment of product.
  • Tracks and monitors internal open Deviations, Investigations and CAPA to closure in compliance with company procedures.
  • Assigns appropriate expiration/retest dates on MEI investigational materials/products. 
  • Addresses shipping and storage temperature excursion notifications related to investigational products.
  • Provides quality approval of new and revisions to existing MEI controlled documentation – e.g., SOPs, Forms, and Specifications.
  •  Receives, initiates and oversees investigation into product complaints for Investigational products.
  • Provides guidance and support as a Quality representative on internal project teams.
  • Tracks, evaluates and approves changes made to products, processes and GMP vendors.
  • Collects, reviews and reports on Quality Metric data for Management Review purposes.
  • Other QA activities may be performed as required.

Job Requirements and Education:

  • Bachelor’s degree in a scientific/technical discipline with 10+ years’ pharmaceutical experience, or an equivalent combination of education and experience with expertise in the following:  
  • Operation within a virtual manufacturing environment.
  • Current FDA, EMA, PMDA regulations and ICH guidances concerning the manufacture and testing of investigational and commercial products. 
  • Risk-based decision-making processes. 
  • Business, scientific, and personal computer hardware and software applications (MS Word, Excel, Access, Outlook, Adobe Acrobat) as well as with Electronic Data Management Systems.  Experience with MasterControl desirable.
  • High level of professionalism and collaboration in team settings. A willingness to adapt to changing situations.
  • Experience in Drug substance or Drug product manufacturing desirable.
  • Well-developed communication skills – written and verbal.
  • Ability to work independently.
  • Ability to manage tasks with competing priorities or deadlines.
  • Successful experience in fast-paced entrepreneurial environment.
  • This is an office-based San Diego position with a potential for travel as needed.

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lifting to 25 lbs.
  • Routine office duties including computer keyboard use.
  • Vision requirements include close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

 

Apply Here

Senior Director, Marketing

Job Summary: The Senior Director, Marketing reports to the Senior Vice President, Marketing. This position will lead the marketing activities to design, develop, and execute a successful US commercialization strategy for the launch of MEI Pharma’s first commercial product. This individual will be responsible for developing a commercial strategy that is coordinated across all aspects of the launch preparation and requires a leader to partner effectively with cross-functional partners in clinical development, insights/analytics, market access, medical affairs, and our alliance partner. The Senior Director, Marketing position is also critical to engaging external stakeholders to ensure other colleagues to maximize the commercial success of zandelisib throughout its’ lifecycle. This position will be an important leader to support the mission to develop and deliver life-changing therapies to people living with cancer.

 Role & Responsibilities:

  • Working with a cross-functional team and our alliance partner, initiate and lead market development activities for hematology indications
  • Develop, evaluate and evolve the brand strategy, including the creation of both strategic and operational plans
  • Play a leadership role in the development and execution of US marketing and commercialization plans for zandelisib in hematologic indications. Plan will include, but not limited to: communication strategies, product positioning, messaging, promotional plans, sales and demand forecasts, life-cycle plan, sales force size and deployment, sales training plan, market access plans, customer segmentation, and targeting
  • Keep up to date with the competitive landscape for the brand to continue to build a competitive advantage for the brand
  • Lead the development of marketing, promotional, educational, and disease awareness and sales materials in accordance with regulatory requirements
  • Prepare and deliver presentations to senior management on all aspects of organizational launch readiness
  • Lead and develop team members as the team grows. Ensure all members receive sufficient coaching and mentoring to achieve objectives
  • Participate in cross-functional Product Development Teams accountable for overall life cycle planning
  • Foster commercial relationships with key research centers in the US

Qualifications:

  • Prior people management experience preferred
  • Previous experience working in an alliance a plus
  • Sales, sales management experience a plus
  • Excellent written, communication, and interpersonal skills and proven success working in a multi-functional, team-based environment
  • Previous launch experience is ideal
  • Work independently under general supervision. Exercise judgment within generally defined practices and policies

Job Requirements and Education:

  • BS degree required
  • MBA preferred, specifically in Marketing or Healthcare Management
  • Minimum 10 years of pharmaceutical experience required, at least 7 of which are in product management or comparable function
  • Hematology/oncology US marketing experience required
  • Lymphoma experience strongly preferred
  • Ability to travel up to 30%
  • Based at MEI headquarters in San Diego

Employment type:

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Senior IS Business Systems Analyst

Job Summary: The Senior IS Business Systems Analyst reports to the Enterprise IS Manager, Information Systems, and will be primarily responsible for supporting enterprise applications pertaining to MEI Pharma’s NDA (New Drug Applications) that are submitted to the FDA. In addition, support of enterprise applications across all MEI business lines, including Finance, Quality, Regulatory, and Clinical, will be required.  The Senior, IS Business Systems Analyst is responsible for installing, updating, and maintaining software or applications. Main duties include a focus on working with enterprise applications that organizations use for business operations. These apps can include enterprise resource planning (ERP), Document Management, Quality Management Systems, Regulatory Systems, and Enterprise Architecture tools. After installation, configuration, or software customization, testing and/or debugging, as necessary. Other responsibilities include managing employee access to computer systems, troubleshooting issues, and providing user support.

In addition, this individual works with various business lines and application vendors to ensure application availability. Will handle business relationship management and project implementation. This includes the identification of business challenges, solutions to meet those challenges, processing of requirements, and models to support the solutions. This position will work in conjunction with the desktop support group on an as-needed basis is.

 

Role & Responsibilities:

  • Provide support, particularly administrative support, for current enterprise applications across MEI, in particular for regulated business areas
  • Process flowcharting, strong with documentation, UAT execution
  • Perform selection/design and implementation projects for new software systems and enhancements to existing systems using the MEI IS project management process
  • Proactively work with business lines identifying opportunities for enhancing operations through the application of technology
  • Maintain and enhance Enterprise Architecture models
  • Assist in the execution of risk management activities related to cybersecurity
  • Strong communication skills and excellent customer service

Qualifications:

  • Possess significant knowledge of Pharmaceutical company processes
  • Experience in enterprise application maintenance and support
  • Familiarity with GxP, SOx, and privacy regulation (e.g., GDPR, CCPA) requirements
  • Experience with Veeva Vault/RIM, MasterControl, and Netsuite desirable
  • Microsoft SharePoint application and system administration experience
  • Familiarity with Archimate modeling language and principles of Enterprise Architecture

Job Requirements and Education:

  • Bachelor’s Degree or equivalent work experience
  • 5-10 years work experience in related field is required
  • Technical certifications Preferred

Employment type

  • Full time

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
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Senior Manager, Regulatory Affairs Operations

Job Summary: Reporting to the Director, Regulatory Affairs Operations, the Senior Manager, Regulatory Affairs Operations is a RA team leader for electronic submission activities. The individual electronically prepares FDA submission documents that are complete, accurate, on time, and electronically functional for MEI’s early and late-stage oncology-related drugs. The individual will lead document and eCTD publishing activities and assist with submissions, including INDs, eCTDs, NDAs, supplements, and amendments. The individual will assist with the maintenance of MEI’s EDMS and eCTD systems. Responsibilities also include archiving regulatory submissions in accordance with company standards.

 Role & Responsibilities:

  • Manages the publishing and compilation of MEI’s electronic submissions, ensuring timelines and company quality standards are met.
  • Manages the document formatting and publishing activities for all submissions.
  • Manages system releases for MEI’s EDMS and eCTD software. Manages the change control process and participates in validation activities on potential configuration changes.
  • Trains company personnel and consultants in the use of MEI’s EDMS.
  • Trains Regulatory Operations personnel and consultants in the use of MEI’s eCTD software.
  • Trains company personnel and consultants in the use of MEI’s eCTD templates and provides ongoing support to the users.
  • Ensures MEI is current with FDA, EMEA and ICH guidelines for electronic submissions.
  • Authors SOP’s and work instructions for the department.
  • Represents Regulatory Operations at team meetings.
  • Ensures final document components are electronically archived according to the departmental standards.
  • Maintains archive of paper submissions.
  • Interacts with internal departments, vendors and consultants in the completion and compilation of regulatory documents to ensure all components meet Regulatory requirements.
  • Archives and manages health authority correspondence in MEI’s EDMS.

Qualifications:

  • Exercises judgment within well-defined procedures and practices to determine appropriate action. Maintains a positive team spirit and leads by ethical principles.
  • Proven ability to drive results and work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism.
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
  • PC literacy required; Proficient use of technology including MS Office skills (Outlook, Word, Excel, PowerPoint), electronic document management systems, and Internet resources is expected.
  • Ability to perform in a fast-paced, dynamic environment.
  • Strong verbal, written and interpersonal skills.

Job Requirements and Education:

  • BA or BS degree in a related discipline with at least 8 years of Regulatory Affairs Operations experience.
  • Expert knowledge of eCTD submissions.
  • Proficiency of the following is required:  EDMS (Veeva Vault); eCTDmanager or similar eCTD systems; Toolbox; StartingPoint Templates.
  • Expert knowledge and experience of FDA and foreign regulations and guidelines.
  • Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges in a small company environment.

Employment type

Full time.

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lifting up to 25 lbs.
  • Routine office duties including computer keyboard use.
  • Vision requirements include close vision and ability to focus.
  • Noise conditions range from quiet to moderate.
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Equal Opportunity Employer:

MEI Pharma, Inc.'s policy is to provide equal opportunities to all employees and employment applicants without regard to unlawful considerations of race, color, national ancestry, sex, gender, age, religion, physical or mental disability, medical condition, genetic information, pregnancy, marital status, sexual orientation, gender identity, gender expression, military or veteran status or any other classification protected by applicable local, state or federal laws.

Recruiters, Agencies:

The recruitment and employment process at MEI Pharma, Inc. is managed exclusively through the Human Resources Department with all candidates applying directly in this manner. The company does not accept unsolicited resumes from any source other than from qualified candidates and only for current open positions.