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 commitement 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
We are currently seeking applicants for the following open positions. If your qualifications match the job requirements, please submit your resume for consideration to hr@meipharma.com.

Open Positions

Medical Director

Job Summary:
Under the supervision of the Chief Medical Officer, the Medical Director drives and executes the goals for the study design, plan, protocol development, implementation and monitoring of the company’s Phase I/II 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.
  • 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.
  • Coaching and mentoring less experienced Clinicians as assigned.
Requirements:
  • Doctoral-level Medical Doctor (MD) with Hematology and/or Oncology experience required
  • 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
  • Leadership skills including a collaborative and team-oriented approach.
  • Organizational, time management and interpersonal skills, proficiency in computer and software skills
  • Experience with regulatory submissions is an asset
  • Available for some travel, including overnight stays.

Senior Manager Clinical Operations

Job Summary:
MEI Pharma, Inc. is seeking an experienced, highly motivated professional to successfully manage global clinical trials. This person reports to the Executive Director of Clinical Operations and will be an integral member of the clinical operations team whose work enables the company to meet defined goals for the clinical development program. He/she will be responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report – utilizing best practices in order to ensure budgets, timelines and performance requirements are met. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors. The Senior Clinical Operations Manager collaborates with other functional peer groups at various management levels and senior management to ensure proper conduct and timely completion of all projects.

Responsibilities and Duties:
  • Manage relationships with existing and new CROs and other vendors, including managing timelines and budgets for outsourced study management activities. Coordinate all vendors’ activities involved in the clinical trials, e.g., central lab, CROs, including managing the RFP processes and overall budget for each.
  • May assist in developing protocol concept sheet (study design, entry criteria and schedule of assessments table). Review protocols, informed consents and CRFs and track development to completion
  • Create project budgets and manage cost to budgets
  • Create and maintain project timelines for each project and use these timelines to track and manage a project’s progress
  • Review and approve the site contract template and budget template. Will review and approve any variations to the template
  • Review study-related support materials (e.g., Study Management Plan, Monitoring Plan, Data Management Plan)
  • Review actual trial conduct and quality at all levels (i.e., monitoring, data management)
  • Ensure review of Clinical Trial Master File for completeness
  • Ability to negotiate and manage competing priorities across multiple functional areas
  • Ensure all functional groups provide deliverables (i.e., query generation and resolution, data base lock, study report). Inform all groups of deliverables and timeline, project developments and ensures completion according to timelines
  • Prepare high-quality reports for management on program status and issues
  • Ensure clinical trials are conducted in compliance with applicable ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations
  • Work independently, exercise appropriate judgment and coach other team members for effective communication
Minimum Requirements:
  • Manage relationships with existing and new CROs and other vendors, including managing timelines and budgets for outsourced study management activities. Coordinate all vendors’ activities involved in the clinical trials, e.g., central lab, CROs, including managing the RFP processes and overall budget for each.
  • May assist in developing protocol concept sheet (study design, entry criteria and schedule of assessments table). Review protocols, informed consents and CRFs and track development to completion
  • Create project budgets and manage cost to budgets
  • Create and maintain project timelines for each project and use these timelines to track and manage a project’s progress
  • Review and approve the site contract template and budget template. Will review and approve any variations to the template
  • Review study-related support materials (e.g., Study Management Plan, Monitoring Plan, Data Management Plan)
  • Review actual trial conduct and quality at all levels (i.e., monitoring, data management)
  • Ensure review of Clinical Trial Master File for completeness
  • Ability to negotiate and manage competing priorities across multiple functional areas
  • Ensure all functional groups provide deliverables (i.e., query generation and resolution, data base lock, study report). Inform all groups of deliverables and timeline, project developments and ensures completion according to timelines
  • Prepare high-quality reports for management on program status and issues
  • Ensure clinical trials are conducted in compliance with applicable ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations
  • Work independently, exercise appropriate judgment and coach other team members for effective communication


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.

MEI Pharma Careers

HR Contact

To apply for a position, please submit your resume for consideration to:
hr@meipharma.com