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 Manager / Associate Director, Regulatory Affairs Operations

Job Summary:

Reporting to the Senior Vice President of Regulatory Affairs, the Senior Manager/Associate Director of RA Operations is the RA team leader for electronic submission activities.  The individual electronically prepares FDA submission documentations that are complete, accurate, on time, and electronically functional for MEI’s P1 – Phase III stage oncology-related drugs. The individual will publish complex, non-routine reports such as technical, nonclinical, and clinical reports, and assist with submissions, including INDs, eCTDs, NDAs, BLAs, supplements and amendments as well as help establish and assist with MEI electronic document control systems. Responsibilities also include archiving regulatory submissions in accordance with company standards.

Management Responsibilities:  None at this time

Responsibilities:

  • Manage outside vendors responsible for electronic submissions and components of the submission process.
  • Lead current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives utilizing systems and tools for electronic document capture, generation, manipulation, scanning and QC.
  • Train company personnel and consultants in the use of electronic document templates and provide ongoing support to the users.
  • Stay up-to-date on ICH eCTD initiatives.
  • Work closely with MEI Data Management to ensure compliance with evolving data standards.
  • Represent Regulatory Operations at team meetings.
  • Ensure final document components are electronically archived according to the departmental standards.
  • Maintain archive of paper submissions.
  • Oversee and ensure compliance with regulatory procedures and work practices.
  • Identify and record issues that require resolution prior to finalization and liaise with responsible author to resolve issues. Assist authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in the correct format.
  • Assist QA with establishing and maintaining electronic document control systems.

Requirements:

  • BA or BS degree in a related discipline with at least 10 years of Regulatory Affairs Operations experience.
  • Experience with pharmaceutical and clinical development of NCEs (in Oncology and Hematology desired).
  • Expert knowledge and experience of FDA and foreign regulations and guidelines.
  • Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges in a small company environment.
  • Exercises judgment within well-defined procedures and practices to determine appropriate action.  Maintains a positive team spirit and leads by ethical principles.
  • Proven ability to drive results and work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism.
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
  • PC literacy required; Proficient use of technology including MS Office skills (Outlook, Word, Excel, PowerPoint), document management systems, and Internet resources is expected.

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lift 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 Science Liaison

Job Summary:

Reporting to the Senior Vice President of Clinical Development, 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 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.

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.