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, Clinical Operations

Job Summary:  MEI Pharma is seeking an experienced Clinical Operations professional to support our oncology trials. The AD, Clinical Operations will manage clinical study vendors, ensuring studies are completed in accordance with the protocol and ICH GCP requirements. The AD, Clinical Operations may support multiple studies and will oversee a variety of critical activities including vendor and site selection, vendor oversight, clinical data review, and inspection readiness.

Role & Responsibilities:

  • Demonstrate a thorough understanding of the drug development process and international standards (ICH GCP) and apply this knowledge to all aspects of MEI’s clinical trials (startup, conduct, reporting, and closeout)
  • Assist in planning clinical trials and tracking study progress, including timelines, budgets, and resource requirements
  • Communicate study status to internal stakeholders and escalate the issue to MEI leadership
  • Develop Requests for Proposals (RFPs) and define the scope of services for outsourced clinical activities
  • Coordinate vendor selection activities, seeking input from other internal functional groups
  • Ensure qualification of service providers in accordance with MEI Pharma’s SOPs
  • Oversee development of study-related plans and ensure adherence to all processes and procedures
  • Oversee setup, maintenance, and close-out of Trial Master Files and ensures they are complete and audit-ready
  • Identify and resolve operational issues to ensure achievement of study milestones
  • Ensure study data are collected and managed in accordance with the study monitoring plan and data quality standards
  • Ensure timely and appropriate response to clinical site issues or other study management problems
  • Participate in protocol deviation listing reviews and ensure deviations are addressed to prevent re-occurrence
  • Participate in the protocol, table, figure, data listings, and clinical study report reviews
  • Assist with MEI clinical operations process development and training initiatives
  • May manage MEI clinical operations staff or consultants

Qualifications:

  • Demonstrated problem-solving skills
  • Excellent communication and interpersonal skills
  • Ability and willingness to travel up to 25% of the time, including domestic and international travel
  • Highly motivated team player willing to work and collaborate cross-functionally

Job Requirements and Education:

  • Bachelor’s degree in health or biological sciences or other scientific discipline preferred
  • Oncology therapeutic area experience strongly preferred
  • Global clinical trial experience strongly preferred
  • Minimum of 8 years of clinical study management experience
  • Proven track record of successfully managing clinical studies, including oversight of vendors, budgets, and timelines
  • In-depth knowledge of ICH-GCP guidelines and regulations and the ability to apply them
  • Strong understanding of the drug development process
  • Strong analytical skills and operational management with attention to detail

Employment type:

Full time 

Apply Here

Manager, Clinical Data Management

Job Summary: MEI Pharma, Inc. is seeking an experienced, highly motivated professional to successfully manage and oversee data management activities for global clinical trials. 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.  He/she will be responsible for the execution and oversight of CROs’ data management activities – utilizing best practices in order to ensure budgets, timelines and performance requirements are met. The position is responsible for coordinating all data management efforts for the trials, both within the Company and through a wide variety of vendors.  The Senior Manager, 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.

 Role and Responsibilities:

  • Oversight of all data management activities and deliverables on assigned clinical studies
  • Manage and oversee CROs handling clinical data, including managing their timelines and budgets
  • Work with CROs and Medical Monitors to coordinate activities for the medical review of clinical trial data
  • Work with biostatistician and SAS programmers to ensure CDISC data standards (CDASH/SDTM) are implemented
  • Provide review and oversight of database design, UAT, and deployment to ensure quality and efficiencies through data and process standardization
  • Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews), and provide feedback to CRO
  • Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
  • Lead interactions between MEI Pharma and external data vendors on the collection, transmittal, and transfer of clinical trial data; support review and reconciliation of external data; coordinates/leads SAE reconciliation
  • Review clinical study protocols and statistical analysis plans and ensure data quality for data analyses
  • Ensure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines, as they pertain to data management activities
  • Manage competing data management priorities across multiple studies
  • Work independently, exercise appropriate judgment, and coach other team members for effective communication
  • Assessment of data management vendors
  • Assist in the compilation of clinical data for regulatory submissions
  • Previous experience in the management of budgets
  • In-depth knowledge of all aspects of data collection and query resolution in clinical studies
  • Strong working knowledge of GCP, CDASH, and CDISC data structures, 21 CFR Part 11, ICH guidelines, and FDA regulations
  • Working knowledge of data management software (EDC, IXRS, ePRO, and other remote capture systems used in the industry)
  • Knowledge of EDC systems(e.g., Oracle Inform, Medidata Rave), Argus platform, and general understanding/use of SAS
  • Demonstrated capabilities and proven track record of problem-solving skills
  • Excellent communication skills (oral and written) and interpersonal skills
  • Ability and willingness to travel up to 10% of the time, including domestic and international travel
  • Highly motivated team player willing to work and collaborate cross-functionally

Job Requirements and Education:

  • Bachelor’s degree in data management or related field of study preferred
  • Oncology therapeutic area experience preferred
  • Minimum of 4 years data management (with Bachelor’s degree) or 6 years data management (without Bachelor’s degree) experience in the pharmaceutical/biotech/CRO industry
  • Direct experience in oversight of data management vendors

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

Manager, Clinical Operations (Trial Master File)

Job Summary:  MEI Pharma is seeking an experienced Trial Master File (TMF) Manager to oversee TMF activities for ongoing clinical trials. The TMF Manager will work with MEI study team members and contract research organizations to ensure TMF quality and support inspection readiness efforts.

Role & Responsibilities:

  • Oversight of vendor TMF set-up activities for MEI-sponsored clinical trials
  • Monitor completeness and quality of TMF content from study start-up through closeout
  • Establish standard metrics and performance indicators for TMF compliance
  • Develop, track, document, and communicate TMF metrics and indicators results to Clinical Operations and other TMF stakeholders
  • Assist in leading the TMF operational strategy, which includes vetting eTMF technologies and supporting the implementation of an in-house eTMF system
  • Act as a business process owner to develop, review and implement TMF policies and procedures
  • Support the preparation of appropriate audit and inspection responses
  • Management of eTMF vendors

Qualifications:

  • Able to independently manage projects in a fast-paced environment and deliver results within tight timelines
  • Effective written and oral communication skills
  • Excellent organizational and time management skills
  • Strong analytical and problem-solving skills
  • Proficient in the use of information technology, especially eTMF and Electronic Document Management systems

Job Requirements Education:

  • Bachelor’s degree required unless equivalent industry experience with an Associate degree in a related healthcare field (i.e. Medical Technician, Lab Technician, LVN etc.)
  • At least 5 years of experience in the pharmaceutical industry in Document Management or Clinical Operations, including experience in study start-up, maintenance, and closeout
  • Experience performing TMF quality and completeness reviews
  • Excellent knowledge of ICH GCP and FDA regulations, as well as regulatory agency inspection practices
  • Able to independently manage projects in a fast-paced environment and deliver results within tight timelines

Employment type

Full time

Apply Here

Manager, Human Resources

Job Summary:

The Manager of Human Resources (HR) will report to the Vice President of Human Resources and be responsible for all Human Resources Business Partner aspects for certain client groups within the organization including performance management, benefits and compensation, career development, company culture, recruiting, hiring, termination, employee relations, and employee communications. There will also be HR operations-related projects and/or programs that this position will be responsible for managing.

 Role & Responsibilities:

  • Manage the day-to-day delivery of human resource services to his/her specific client groups and in some instances the entire organization.
  • Provide support to management on issues relating to headcount growth, organizational structure, organizational effectiveness, recruitment, compensation, company culture, and any human resource issues that arise.
  • Provide support to management and employees in a variety of areas including employee relations, training, compensation, staffing, performance management, and employee development.
  • Provide support and implement consistent processes and procedures across the Company, including salary and employee changes, promotions, new hires, recruitment, terminations, performance, benefits, leaves, policies and procedures, and employee relations.
  • Participate and manage annual performance reviews and compensation for the organization, assist in the analysis of benchmarks and metrics against industry comparables and standards.
  • Ensure compliance with applicable laws, rules, and regulations and company policies and procedures.
  • Ensure employee files and records; ensure completeness and accuracy of records including job descriptions; and
  • Assist in investigations, if any, concerning discrimination and/or sexual harassment and internal grievances.
  • In addition to HR Business Partner duties for specific internal departments, potential HR projects/programs will be assigned as “project leaders” such as compensation, benefits, performance management, HR Training, etc.

Qualifications:

  • High energy and thrive in a fast-paced, high-growth work environment.
  • Extensive knowledge of employment laws and practices.
  • Willingness to handle own administrative needs.
  • Able to manage multiple demands and shifting priorities.
  • Must be able to effectively communicate with senior management as well as other employees and external partners.
  • Strong collaborative and business partnering skills and experience.
  • Experience with implementing an ATS system preferred.
  • Proficient in Excel and Microsoft Office Suite.
  • Experienced with HRIS and plus w/ Coastal platform experience.
  • Friendly and approachable.
  • Sound judgment, high levels of integrity, and quality.
  • Excellent leadership skills.

Job Requirements and Education:

  • Education:  Bachelors’ degree in business or related field.
  • Experience:  At least 8 years of experience in all aspects of human resources in a biotech and/or pharmaceutical company, including 3 years in a Manager or equivalent HR role. 

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

Medical Science Liaison- (All US Regions)

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 through scientific exchange.  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
  • Contributes to the development of educational slide decks
  • Supports training of external presenters on behalf of MEI research and products
  • Ensures all activities are compliant with MEI’s company policies
  • Supports the launch of MEI-approved products and acts as field-based expert resource to MEI cross-functional team members

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 (MD, PhD, PharmD, DSc, BE/BC) 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 

Apply Here

Senior IS Business Systems Analyst

Job Summary: The Sr IS Business Systems Analyst reports to the Enterprise IS Manager, Information Systems and will be responsible for supporting and maintaining business applications used throughout the enterprise. Support of these business lines at MEI include Finance, Quality, Regulatory and Clinical. The Sr IS Business Systems Analyst is responsible for installing, updating, and maintaining software or applications. Main duties include focus on working with enterprise applications that organizations use for business operations. These apps can include Document Management, Quality Management Systems, Regulatory Systems, Financial systems and Enterprise Architecture tools. After installation, configuration, or software customization, testing and/or debugging, as necessary. Other responsibilities include managing employee access to the computer systems, troubleshooting issues and providing user support.

In addition, this individual works with various business lines and application vendors to ensure application availability, business relationship management and project implementation. This includes the identification of business challenges, solutions to meet those challenges, and development of models to support development and implementation. 

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

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

 

Apply Here

Senior Manager, Project Management

Job Summary: Reporting to the VP Program and Alliance Management, the Sr Manager / Director, Project Management will work with the Company’s product development leadership team to support the development and life cycle management of the Company’s therapeutic products. (this position will support Voruciclib and ME-344 primarily) The position will provide program management and leadership to support clinical product development activities, partnering with external collaborators as well as internal functional area groups.  The position will drive the execution of program plans, facilitate project team meetings. manage project timelines and serve as a key interface of a number of cross-functional areas including research, manufacturing, clinical, and regulatory. As such, prior team leadership/project management experience with oncology product development from pre-clinical to late-stage development is essential.  This role will also work with functional area leaders to prioritize work and ensure appropriate resourcing to deliver on project plans.

Role and Responsibilities:

  • Provide leadership, direction, and coordination across functional areas to drive integrated delivery of oncology product development programs.
  • Actively and effectively manage the delivery of program goals and cross-functional timelines in accordance with the program strategy (i.e. management of integration, scope, timeline, cost, quality, resources, communications risks and procurement).
  • Create and monitor project plans and timelines, and update work plans as appropriate to meet changing needs and requirements.
  • Partner with the team to proactively identify and highlight risks and issues within the project; work with the team to devise and implement effective risk mitigation strategies.
  • Strong knowledge of regulations, guidelines, and company/regulatory needs concerning project conduct.
  • Apply project management best practices in the planning, alignment, initiation, execution, control and closing of projects.
  • Drive content and timing of key internal team meetings.
  • Facilitate and manage effective team meetings, track action items and deliverables.
  • Ensure progress of projects and timely deliverables.
  • Develop tools and processes to increase efficiencies of program management and program execution.
  • Effectively communicate project expectations to team members and stakeholders in a timely, credible and clear fashion.
  • Build and maintain strong team dynamics and morale.
  • Partner with functional area leaders on resource planning and budgetary requirements for timely completion of projects.

Qualifications:

  • Strong leadership and teamwork skills.
  • Strong relationship building, communications, and stakeholder management skills.
  • Solid understanding of product development.
  • Strong oral and technical/medical writing capability.
  • Attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
  • High level of proficiency in MS Project, Word, Excel, Outlook, Visio, and PowerPoint.
  • Demonstrated ability to work both independently and in a team-oriented, highly collaborative, small company environment.
  • Can conform to shifting priorities, demands, and timelines.
  • Ensures timely completion of tasks assigned, ensuring compliance of the team.
  • Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information; independently make timely decisions.
  • Demonstrated capabilities and proven track record of problem-solving skills.
  • Excellent communication skills (oral and written) and interpersonal skills.
  • Highly motivated team player, willing to work and collaborate cross-functionally.

Job Requirements and Education:

  • Required Education: Bachelor’s degree, Master’s degree preferred.
  • Area(s) of expertise desired: Life Science or Chemistry.
  • Background in drug/oncology product development.
  • Minimum8 years’ experience in the biopharmaceutical industry, with a minimum of 5 years in a leadership role, with direct responsibility for managing global projects.
  • Prior experience with NDA/MAA submissions preferred.
  • Prior experience in alliance management is a plus.
  • Familiarity with drug development regulations and GCP.
  • Project management professional certification is desired but not essential.
  • Ability to travel up to 20%.
  • This is an in-house position at our San Diego office. 

Employment type

Full time 

 

Apply Here
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.