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 Director, Clinical Operations

Job Summary:

Reporting to the Senior VP Clinical Development, the Senior Director directs clinical trials and data collection, working on abstract problems across functional areas of the business.  Establishes and may oversee implementation of clinical operation processes, clinical protocols, data collection systems and final reports. Monitors adherence to protocols and determines study completion.  Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters.  Directs activities of one or more functional areas in the Clinical Department.  Responsible for managing the implementation, testing, monitoring and documentation of results of clinical studies; oversees the company’s clinical research projects at various clinical sites.  Develops and ensures adherence to the clinical operations budget.      

Management ScopeManages the Clinical Operations Department staff.

Responsibilities & Duties:

  • Develops clinical trial budgets and negotiates fees with clinical sites and service providers.
  • Develops systems for reporting of data for analysis and final reports.
  • Directs activities of clinical trials and designated staff at clinical sites
  • Stays current on FDA regulations literature review.
  • Travels to field sites as needed.

Minimum Requirements:

Bachelors degree, MS, RN or equivalent with 8 + years of experience.  Ability to communicate with excellent interpersonal, presentation, written, verbal, analytical and organizational skills, project management, management and computer expertise.  Possess a strong commitment to quality and accuracy as a self-starter and a team-player in a fast-paced, start-up like environment. 

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.

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.

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.