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

Data Privacy Manager

Job Summary:

The role will be responsible for ensuring MEI Pharma Inc. (MEI) is compliant with all relevant legislation on data protection, as well as company-wide data protection guidelines and standards. This role will involve ensuring the appropriateness of current data protection policies, maintaining the privacy program, and ensuring that operations are in accordance with best practice.

On an ongoing basis the position will be responsible for fielding all internal and external data protection issues and queries, seeking legal advice or working with internal officers as well as outside representatives where needed.  Additionally, the role will also be responsible for annual awareness training for MEI staff.

Role & Responsibilities:

  • Manage privacy / data protection compliance activities and best practices internally including working closely with legal to review, interpret, comment and provide leadership on proposed and enacted regulations and industry-best practices.
  • Develop and implement Privacy Impact Assessments.
  • Work closely with the all internal teams to identify and address data privacy issues or concerns in new or existing processes, clinical trials, products and services and IT systems/software including conducting formal privacy impact assessments.
  • Works with Legal, legal counsel and other related parties to represent the organization’s information privacy interests with external parties (state or local government bodies such as the Data Protection Authorities) who undertake to adopt or amend privacy legislation, regulation, or standards.
  • Develop training strategy and materials and conduct company-wide training to ensure that employees are well-informed on key privacy issues.
  • Undertake systematic privacy / data protection compliance audits, including any third-party premises where appropriate.
  • Responsible for working with MEI Executive Team members and/or EU Data Representative to ensure appropriate responses are sent to all requests for access to information that are received by the organization as well as assist in being a contact with the relevant regulator regarding potential complaints and breaches and ensuring that requests for information are properly handled.
  • Assist with investigations into complaints about breaches of the act and undertake reporting/remedial action as required.
  • Define, update and maintain the data register of processing activities and the retention schedule and work with the appropriate business functions as required.
  • Follow evolving GDPR landscape and privacy initiatives and work with Legal and other related parties to assess impact on MEI practices or procedures.

Qualifications:

  • Bachelor’s degree.
  • CIPP certification or equivalent data protection certification.
  • 5+ Years’ experience working in data privacy or aligned field. 
  • Demonstrated organization, facilitation, communication, and presentation skills.
  • Ability to simplify and teach others privacy-related concepts.
  • Biopharmaceutical or biotechnology experience is necessary.
  • Excellent verbal and written communications skills are necessary as well as attention to detail and technical aptitude.
  • Proven experience in dealing with the public and/or complaints procedures.

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment.
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Routine office duties including computer keyboard use and some lifting of light-weight office equipment, supplies and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.
Apply Here

Department Administrator

Job Summary:

The Department Administrator must have proven ability to thrive in a team environment and be willing to assist team members as needed.  This position will interact closely with all team members internally, outside visitors, as well as consultants.

Role & Responsibilities:

  • Works independently and within a team environment on special nonrecurring and ongoing projects.
  • Preparation of various Word documents, Excel spreadsheets and PowerPoint presentations as assigned.
  • Oversight of offsite document storage activities.
  • Compilation and quality control of paper-based briefing packages.
  • Assist team members in daily duties including addressing inquires, researching issues and interfacing with other departments including assistance with travel and conference bookings.
  • Customer service via greeting visitors and answering phones.
  • Work closely with the other administrative staff members.
  • Maintain shared workspaces including kitchen, breakroom, meeting rooms and reception area ensuring all supplies are stocked accordingly.

Qualifications:

  • Minimum of 3 - 5 years of experience is preferred.
  • Proficient in all Microsoft applications as well as Adobe Acrobat.
  • Strong interpersonal skills and the ability to work independently as well as in a team environment.
  • Must have exceptional verbal and written communication skills.

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment.
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Routine office duties including computer keyboard use and some lifting of light-weight office equipment, supplies and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

 

Apply Here

Manager, Quality Systems

Job Summary:

Reporting directly to the Director of Quality Assurance, the Quality Systems Manager is responsible for maintaining and execution of systems and processes to ensure compliance with cGMP regulations. The role is responsible for providing quality guidance and working with MEI internal departments to meet company goals and objectives.  Key functions are in the areas of Investigations, Exception reporting, Computer systems, Quality Metrics, Risk Management, Internal Audits, and CAPA management. 

Role & Responsibilities:

  • Tracks, monitors, processes and approves MEI Investigations, Product Complaints and Exception Reports in compliance with established procedures.
  • Supports the establishment and change control of GXP compliant computer systems at MEI.
  • Establishes, monitors and reports Quality metrics to MEI management.
  • Manages the internal audit program including scheduling and performing internal audits. 
  • Evaluates adequacy and effectiveness of corrective action plans.
  • Monitors the completion of CAPA generated as the result of audits, investigations, and/or regulatory inspections.
  • Works with Regulatory Affairs to compile and generate Annual Product Reviews from which Annual Reports are filed with FDA.
  • Assists with preparation for regulatory inspections.  Provides support during inspections.
  • Establishes and maintains MEI quality systems and supporting policies and procedures.
  • Follows applicable regulations, including FDA, ICH, GXP, and MEI policies and procedures.
  • Other QA activities may be performed as required.

Qualifications:

  • Bachelor’s degree in a scientific/technical discipline with 7+ years’ pharmaceutical experience, or an equivalent combination of education and experience with expertise in the following:  
  • Pertinent federal and state laws related to pharmaceutical industry.
  • Current FDA, EMA and federal regulations and guidance concerning the conduct of clinical research including Good Clinical Practice (GCP), desirable. 
  • Experience in establishment and maintaining Commercial Pharmaceutical QA systems. 
  • Experience with Business, scientific and personal computer hardware and software applications (MS Word, Excel, Access, Outlook, Adobe Acrobat) as well as with Electronic Data Management Systems and their implementation.
  • High level of professionalism and collaboration in team settings.
  • 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 some travel as needed.

ADA Notations:

  • This job operates in a professional office environment using standard office equipment.
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lifting up to 20 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 Director – Clinical Hematology-Oncology

Job Summary: 

Under the supervision of the Senior Vice President, Clinical Development, the Medical Director plans and executes the study design protocol development, implementation and monitoring of the company’s Phase I/III Oncology/Hematology clinical trials.  The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures.

Responsibilities: 

  • Assist in or design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents.
  • Discuss study design with investigators and key opinion leaders.
  • Provide clinical input for clinical protocol monitoring guidelines and analysis plans.
  • Drive clinical interpretation of study data.  Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur.
  • Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling).
  • Lead or assist in the development of publications – abstracts, manuscripts, slides, etc.
  • In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status.
  • Assist in database finalization, reviews of study results, results interpretation and CSR’s.
  • Assist in planning and presentation conduct of investigator meetings and Advisory Boards.
  • Assist with field site questions during conduct of trials as needed.
  • Present study results, as appropriate, to medical/scientific community at meetings and in published format.
  • Coaching and mentoring less experienced Clinicians as assigned.

Requirements:

  • Medical Doctor (MD) with experience in malignant Hematology and/or solid tumors required; recent experience in lymphoid and/or myeloid malignancies preferred.
  • 4-8 year’s clinical development experience in the pharmaceutical or biotechnology industry  (depending on title or degree)
  • Phase I–III clinical trial experience preferred
  • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts
  • Working knowledge of the IND/NDA process
  • In depth knowledge of GCP/ICH guidelines
  • Strong written and verbal communication skills (fluency in written and verbal English) as well as proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
Apply Here

Medical Science Liaison - Southern or Western US

Job Summary

Reporting to the Director of Medical Affairs, the Medical Science Liaison (MSL) is a field-based position that develops and enhances professional relationships with medical thought leaders, investigators and key medical organizations involved in cancer drugs development.  The MSL provides medical information through medical and scientific discussions and communications in a balanced, non-promotional manner.  The role is performed in accordance with all applicable legal, regulatory and professional guidelines.  This is a challenging position in a fast-paced setting that requires a highly-motivated, self-starter. 

Responsibilities

  • The MSL ensures the appropriate dissemination of clinical and scientific information regarding MEI’s oncology pipeline compounds in a timely and customer-focused manner to all appropriate parties.
  • Identifies specific Key Opinion Leaders in the oncology field and establishes and maintains scientific relationships with them in their academic and community cancer centers around the country.
  • Provides clinical communication through presentations and information in response to questions from the academic and healthcare-provider settings.
  • Collaborates with the in-house Clinical Operations Department to enhance patient enrollment in company-sponsored clinical trials by identifying appropriate clinical trial sites and interacting with investigators in ongoing studies.
  • Provides scientific and medical information updates and scientific support at medical meetings.
  • Provides timely feedback and information on emerging clinical and scientific teams as well as opportunities to internal staff.
  • Furnishes scientific support for appropriate educational initiatives.
  • Ensures all activities are compliant with MEI’s company policies.

Requirements:

  • Advanced scientific degree (MD, PhD, PharmD) with at least 5 years of relevant industry experience.  Hematology/Oncology MSL experience is strongly preferred along with a solid professional reputation for interacting productively with thought leaders in the field.
  • Thorough comprehension of the oncology drug development process is required.
  • Demonstrated ability and experience to effectively present clinical/scientific information to a variety of audiences is essential.
  • Respectful, accountable and collaborative abilities to work with in-house teams and all outside collaborators.
  • Able to spend a significant amount of time in the field directly interacting with thought leaders, investigators and hematology/oncology professionals.
  • Superior time management skills to balance multiple priorities and to meet deadlines.
  • Ability to create materials such as reports and presentations for inside and outside the organization.
  • Approximately 50-60% travel is required; overnight travel required as needed.
  • Must possess a valid driver’s license and a good driving record.
Apply Here

Senior Manager, 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.

Essential Duties and Responsibilities

  • Oversight of all data management activities, including: developing data management and data review plans, supervising database development, data review, database cleaning and lock activities
  • Reviewing and processing clinical trial data to ensure completeness, accuracy, completeness, and consistency of clinical trial databases
  • 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 coding data and adverse events, medical history, concomitant and protocol-related medications
  • Lead interactions between MEI Pharma and outside vendors (e.g. central laboratories) on the collection, transmittal and transfer of study specific laboratory data
  • Work closely with MEI Pharma and/or CRO’s medical and clinical operations groups, biostatisticians, SAS programmers and other staff as appropriate to develop CRFs to ensure the required information is captured for reporting and statistical analysis 
  • Work with biostatistician and SAS programmers to harmonize data collection, compile and maintain SAS data standards, including CDASH CRF (CDISC) collection, CRF specification guidelines, edit check documents
  • Provide review and oversight of database design, validation, and deployment to ensure quality and efficiencies through data and process standardization
  • Participate in cross-functional team meetings and communicate with appropriate functions regarding project status/issues, provide ongoing feedback on data management workflows to increase efficiency, and provide feedback to CRO.
  • Review study-related support materials (e.g., Data Management Plans)
  • Coordinate the transfer of clinical data between all vendors participating in clinical studies
  • 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
  • Develop and maintain appropriate data management SOPs
  • 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

Education and Competency Requirements

  • Bachelor’s degree in data management or related field of study
  • Oncology therapeutic area experience preferred
  • Minimum of 7 years data management experience in pharmaceutical/biotech/CRO industry
  • Direct experience in management and oversight of data management vendors
  • Previous experience in management of budgets
  • In depth knowledge with 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)
  • EDC software knowledge (e.g., Oracle Inform, Medidata Rave), Argus, 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 time, including domestic and international travel
  • Highly motivated team player willing to work and collaborate cross-functionally.

ADA Notations

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Apply Here

Test Job Position

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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.