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

Senior Medical Writer

Summary:

 

MEI’s Clinical Development Department seeks a Senior Medical Writer with scientific knowledge and writing expertise to effectively communicate technical pharmaceutical drug and scientific medical information to regulatory authorities, clinical study sites, and thought leaders involved in cancer drug development. The position’s particular focus includes protocol development, regulatory submissions, and scientific manuscripts and abstracts.  The position works closely with cross-functional team members to ensure the documents are high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, eCTD requirements and company goals.  The core duties of the medical writer are delineated below.

Responsibilities and Duties:

  • Write, edit and collaborate on development of preclinical, clinical and sections of regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, DSURs, INDs, eCTD/NDA modules, clinical summaries, briefing books)
  • Compile, write, and edit documents covering all phases of MEI’s clinical oncology/ hematology research, to include integrated summaries of data, risk/benefit analysis, etc.
  • Assist in the analysis, synthesis and presentation of complex information for scientific presentations
  • Distill large amounts of clinical and scientific data into essential elements for graphical display.
  • Draft manuscripts, abstracts and posters for submission to medical journals and/or scientific meetings.
  • Provide QC review support as needed and ensure consistency between related documents
  • Understand the levels of evidence required to achieve regulatory and clinical trial goals. Ability to coordinate, plan and manage communications to enable timely review from other authors and reviewers and to function as a collaborative team member.
  • Formulate key messages from clinical study data
  • Perform literature-based research to support writing activities
  • Develop and maintain medical writing processes, SOPs, templates and outlines for key documents
  •  Maintain an awareness of current industry practices and regulatory requirements that affect medical writing. 
  • Keep abreast of current literature, emerging science, technological developments and medical trends.
  • Write summaries and maintain files on informative medical and scientific journal articles.

Minimum Requirements:

  • BS, MS or doctorate  in a scientific or medical discipline with relevant experience
  • 5+ years’ experience in the medical/regulatory/publication writing and editing
  • Experience in a Medical specialty –oncology/hematology is a plus
  • Basic to intermediate knowledge of biostatistical and clinical research concepts
  • Thorough understanding of FDA and ICH regulations and guidelines
  • Experience authoring/editing CSRs and other types of clinical regulatory documents (e.g., clinical protocols, Investigator’s Brochures, NDA modules) or scientific publications including abstracts and posters
  • Proven ability to implement medical writing processes and standards
  • Knowledge of Microsoft Office applications and electronic document management systems; proficiency in Word, Excel, PowerPoint, email, and the Internet.
  • Willingness and ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment; adapts to changing deadlines and priorities.
  • Ability to work collaboratively to coordinate the efforts of team members to complete deliverables.
  • Exceptional oral and written communication skills
  • Flexible, adapts work style to meet organization needs
  • Motivated, self-directed and able to work autonomously and in team settings to meet aggressive organizational goals
  • Available writing samples for MEI review.

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.

Clinical Operations Manager

Job Summary

MEI Pharma, Inc. is seeking an experienced, highly motivated professional to successfully assist in the management of global clinical trials. This person 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 efforts for the trial both within the Company and through a wide variety of vendors.  The Clinical Operations Manager collaborates with other functional peer groups at various management levels and senior management to ensure proper conduct and timely completion of projects.

Essential/ Primary Duties, Functions, and Responsibilities

  • Manage relationships with existing and new CROs and other vendors, including managing timelines and budgets for outsourced study management activities.  Coordinate vendors’ activities involved in the clinical trials, e.g., central lab, CROs, etc.
  • May assist in the development of clinical protocols (study design, entry criteria and schedule of assessments table).  Review protocols, informed consents and CRFs and track development to completion
  • Oversee the Company’s clinical research projects at various clinical trial sites
  • Periodically conduct monitoring visits at clinical trial sites
  • Liaise with investigation site personnel on the conduct of clinical studies
  • Ensure the collection and submission of investigational sites’ regulatory documents are maintained
  • Assist senior-level clinical managers with tracking of project budgets
  • Maintain project timelines for each project and use these timelines to track and manage a project’s progress
  • Review site contract templates and budget templates. 
  • 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 manage competing priorities across multiple functional areas
  • Communicate with other functional groups to ensure awareness of deliverables and timelines and project developments
  • Assist in the preparation of high-quality reports for management on program status and issues
  • Identify and escalate issues needing senior-level management attention
  • 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 collaborate with other team members for effective communication

Education and Competency Requirements

  • Bachelor degree in health or biological sciences or other scientific discipline
  • Oncology therapeutic area experience strongly preferred
  • Minimum of 4 years clinical study management experience in pharmaceutical/CRO industry
  • Experience in managing clinical trials and working alongside contracted resources/CROs
  • Minimum of 3 years of clinical monitoring experience
  • Previous experience in supporting the management of vendors and sites
  • In depth knowledge of ICH-GCP guidelines and regulations and the ability to apply them
  • Strong operational management with attention to detail
  • 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 25% of time, including domestic and international travel
  • Highly motivated team player willing to work and collaborate cross-functionally

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.

Submit CV’s tohr@meipharma.com, bmcomber@meipharma.com and to tbutler@meipharma.com

Senior Clinical Operations Manager

Job Summary

MEI Pharma, Inc. is seeking an experienced, highly motivated professional to successfully manage global clinical trials. This person 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.

Essential/ Primary Duties, Functions, and Responsibilities

  • 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

Education and Competency Requirements

  • Bachelor degree in health or biological sciences or other scientific discipline
  • Oncology therapeutic area experience strongly preferred
  • Minimum of 5 years clinical study management experience in pharmaceutical/CRO industry
  • Direct experience in managing clinical trials and prior management of contracted resources/CROs
  • Previous experience in negotiating vendor/site contracts and management of budgets
  • In depth knowledge of ICH-GCP guidelines and regulations and the ability to apply them
  • Strong operational management with attention to detail
  • 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 25% of time, including domestic and international travel
  • Highly motivated team player willing to work and collaborate cross-functionally

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.

Submit CV’s tohr@meipharma.com, bmcomber@meipharma.com and to tbutler@meipharma.com

Medical Director, Clinical Hematology-Oncology

Job Summary:  

Under the supervision of the Senior Vice President, Clinical Development, the Medical Director plans and executes the clinical 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.
  • Leadership skills including a collaborative and team-oriented approach
  • Good 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
     
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.