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

Biometrics - Director/Senior Director

Job Summary: 

The primary responsibilities of the Director/Senior Director, Biometrics, are to ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis and interpretation of clinical data for all MEI Pharma clinical programs.  In this leadership position within Clinical Development, the Director/Senior Director, Biometrics, manages all operational aspects of biostatistics, data management and statistical programming, either directly with MEI Pharma personnel or indirectly with consultants and clinical research organizations (CRO) personnel.  This position provides leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results.

Responsibilities: 

  • Create and develop Biometrics function at MEI Pharma
  • Provide expertise and guidance to the Clinical Development Team regarding statistical methods for clinical trials data analyses
  • Participate in the protocol development process, including responsibility for sample size and power calculations, and write/review statistical section of reports/protocols
  • Active member of protocol development core team providing input in design, outcome measures, and endpoints assessment
  • Responsible for the oversight and/or preparation of the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR), integrated summary documents and/or publications
  • Review IWRS instructions and plans
  • Responsible for the oversight of the development of SAS programs, either directly or indirectly via CROs, to perform planned or ad hoc analyses and prepare data displays
  • Identify, participate in the evaluation/selection of Biometrics vendors
  • Lead and manage Biometrics vendors
  • Plan and manage Biometrics related submission activities
  • Lead verification of statistical outputs, data sets used and statistical results in regulatory documents and other clinical data reports, manuscripts and abstracts
  • Familiarity with CDISC and Biometrics Related Guidelines
  • Represent the company Biometrics function at FDA/EMA or other regulatory meetings

Requirements:

  • PhD or Masters in statistics or biostatistics
  • Minimum of 7 years of biostatistical, data management and clinical programming experience in the pharmaceutical or biotechnology industry
  • Oncology experience preferred
  • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
  • Extensive knowledge of clinical research methodology and regulatory requirements as they related to trial design and analysis
  • Solid scientific background and understanding of clinical trials, clinical development operations and regulatory compliance.
  • Ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects
  • Experience in managing Biostatistics, Data Management, Statistical Programming and overall resource planning
  • Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skill, SAS, SDTM, ADaM, and CDISC
  • Prior experience with regulatory submissions
  • Prior successful NDA and/or IND submission required
  • Solid knowledge and experience in drug development process
  • Adept at outsourcing and managing biostatistical services provided by CROs and contractors
  • Strong leadership and must be able to collaborate and work with other departments such as Clinical, Finance, Research & Regulatory Affairs
  • Ability to work in a fast-paced environment
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
  • Excellent organizational communication skills
  • Ability to prioritize effectively to deliver results within reasonably established timelines
  • Able to thrive in a small group setting, possesses high energy hands-on attitude

Clinical Operations Manager

Summary:

The Clinical Operations Manager is a highly motivated professional able to manage global clinical trials; the individual 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. 

Essential/ Primary Duties, Functions, and Responsibilities:

  • Responsible for trial conduct and quality at all levels (i.e., monitoring, data management).
  • Create and maintain project timelines for each project and use these timelines to track and manage progress.
  • 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) and informed consent form templates. 
  • Review protocols, informed consent forms and CRFs and track development to completion.
  • Create project budgets and manage cost to budgets.
  • Review and approve the site contract template and budget template and review and approve any variations to the template.
  • Develop or review study-related support materials (e.g., Study Management Plan, Monitoring Plan, Data Management Plan).
  • Ensure review of Clinical Trial Master File for completeness.
  • Conduct ongoing review of data for completeness and accuracy.
  • 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 15% 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).
  • Ability to lift light office supplies and equipment.
  • Routine office duties including computer keyboard use.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

Clinical Research Associate / Sr. Clinical Research Associate (In-House)

Job Summary:

The Clinical Research Associate (CRA) or Senior CRA (SCRA) role is to assist the Senior/Manager, Clinical Operations during the conduct of one or more clinical studies. The CRA/SCRA ensures that clinical study timelines and budgets are met, data quality is high, and the studies are conducted in compliance with current applicable laws and regulations, corporate policies, and ICH and GCP guidelines.

This position is based at MEI’s San Diego office with up to approximately 15% travel, as needed.

Responsibilities:

  • Assists the Senior/Manager Clinical Operations in overseeing clinical studies to ensure compliance with the study protocol, timeline and budget.
  • Coordinates investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
  • Coordinates contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
  • Coordinates and maintains relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.
  • Assists with the design of clinical studies.
  • Assists with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.
  • Reviews clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.
  • Participates in project team meetings and conference calls to review progress of ongoing clinical trials.
  • May conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.

Requirements:

  • Minimum 3 years’ experience as a CRA in the biotechnology or pharmaceutical industry; experience in hematology and/or oncology preferred.
  • Completed (or is in the process of completing) a CRA Certification Course preferred.
  • BS degree in a science or health-related science or equivalent preferred.
  • Proficient knowledge of GCP and ICH and medical terminology.
  • Ability to prioritize and multitask to ensure tasks are completed on or ahead of time.
  • Strong interpersonal and written communication skills.
  • Excellent team, organizational, and planning skills.
  • Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint.

Only San Diego area candidates will be considered; there is no relocation benefit.

Submit resumes to hr@meipharma.com

Manager Drug Supply & Study Planning

Job Summary:

With experience in the pharmaceutical or biotech industry, the Manager, Drug Supply and Study Planning, has oversight of clinical supply chain logistics and study timeline planning for MEI’s drug development studies. The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique supply chain challenges present in a GMP environment.

Management Scope:  None at this time.

Responsibilities & Duties:

Clinical Supply

  • Support clinical study teams with study drug supply demand, forecasting, and logistical planning for all clinical trials
  • Manage vendors, including managing quotes, purchase orders, invoicing and forecasting and demand planning 
  • Support project total drug supply forecasting activities, including lot allocation activities
  • Work closely with CMC and Quality groups for production input into the supply chain, as well as to ensure release of product domestically and internationally
  • Provide expertise with packaging technologies
  • Provide input to the development of IP-related study documents including protocols, study and pharmacy manuals
  • Work with Quality Assurance to review and resolve all shipment issues (damage, temperature excursions, non-compliance).  Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership.
  • Creatively seek out ways to improve supply chain processes.

Study Timeline Planning

  • Work closely with Clinical Operations and Project Management to plan and define clinical study deliverables, timelines, assumptions, and parameters
  • Track study timelines and generate status reports to ensure alignment with study plans and timelines and overall clinical development plan
  • Support scenario planning and evaluations.

Requirements:

  • A Bachelor’s degree in the sciences is preferred
  • Minimum of 5 years of planning experience in clinical supply chains in biotech/pharmaceutical industry
  • Minimum of 2 years of experience of clinical study timeline planning preferred
  • Global release and distribution logistics experience is required
  • Working knowledge of GMP and pharma industry procedures and regulations
  • Theoretical and practical knowledge of clinical supply forecasting and demand planning
  • Must possess import/export expertise including customs, transportation, and regulatory guidelines.
  • Ability to anticipate/define problems, collect and analyze data, make recommendations, and execute corrective actions and preventative measures
  • Strong interpersonal skills and the ability to work independently, as well as a member of a team
  • Must have exceptional verbal, written, presentation, communication and negotiation skills
  • Proficiency with: Microsoft Word/Excel/PowerPoint/Project software
  • Only San Diego candidates considered.

ADA Notations:

  • 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 and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

     

Medical Science Liaison - East Coast

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.  Candidates on the East Coast – preferably NYC and Boston are preferred.

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.
  • Candidates living on the East Coast - NYC or Boston-  are preferred.

Submit CV’s to:  hr@meipharma.com and jwood@meipharma.com.

Senior Accountant

 

Summary:

Reporting to the Executive Director, Finance, the Senior Accountant is responsible for daily accounting activities with overseeing accounts payable/receivable, disbursements, payroll and general ledger activities.  May supervise tax filings and preparation of financial statements; ensures the integrity of accounting information.

Responsibilities:

  • Prepares and records asset, liability, revenue, and expenses entries by compiling and analyzing account information.
  • Maintains and balances subsidiary accounts by verifying, allocating, posting, reconciling transactions; resolving discrepancies.
  • Maintains general ledger by transferring subsidiary accounts; preparing a trial balance; reconciling entries.
  • Summarizes financial status by collecting information; preparing balance sheet, profit and loss, and other statements.
  • Oversees accuracy of payroll by finalizing computer processing and verifying finished product.
  • Completes external audit by analyzing and scheduling general ledger accounts; providing information for auditors.
  • Avoids legal challenges by complying with legal requirements.
  • Secures financial information by completing database backups.
  • Protects organization's value by keeping information confidential.
  • Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

Requirements:

  • Accounting, SFAS Rules, research skills, analyzing information, attention to detail, deadline-oriented, Confidentiality, thoroughness, corporate finance, financial software, general math skills
  • Bachelor’s Degree in Accounting required (Master’s preferred)
  • 5+ years’ experience in general or tax accounting
  • Experience with computerized ledger systems
  • Advanced knowledge of Excel
  • Strong problem solving and analytical skills
  • Ability to function well in a team-oriented environment

Senior Manager / Associate Director, Regulatory Affairs

Job Description

Reporting to the Senior Director of Regulatory Affairs, the successful candidate will contribute to the development and execution of successful regulatory strategy to support investigational products for new or active US and global oncology clinical studies.  This candidate will also represent the regulatory affairs group as part of cross-functional teams to provide regulatory support and guidance. This candidate will coordinate, prepare and support complex and routine regulatory submissions and communicate with FDA.  Responsibilities include the following:   

Responsibilities:

  • Support and execute on regulatory strategies for assigned programs in the area of hematologic  oncology in collaboration with regulatory affairs senior management and through the analysis of regulatory guidance and drug approvals in the competitive space.
  • Provide regulatory guidance to teams to support MEI’s developmental pipeline, including preparation and maintenance of IND or IMPD filings.  Oversee development of US and OUS regulatory filings.
  • Review of documents such as study protocols and reports.  Controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness and regulatory requirements.
  • Prepare and plan regulatory filings including timelines.
  • Support interdepartmental teams in the authoring of regulatory communications such as annual reports or DSURs, and review of essential document packages from clinical sites to enable drug shipment to sites.
  • Communicate with the FDA through drafting submission cover letters, email correspondence and phone communication as appropriate
  • Identify, draft and review Regulatory Affairs SOPs, as necessary, and develop a working knowledge of internal SOPs.
  • Oversee and ensure compliance with regulatory procedures and work practices
    Proactively identify program issues and recommend appropriate regulatory strategies to mitigate risks.

Requirements

  • At least a Bachelor's degree (scientific discipline not required, but a plus), with a minimum of 8 years of experience in Regulatory Affairs
    Experience with pharmaceutical and clinical development of NCEs in hematologic oncology and hematology desired
  • Working knowledge of FDA and foreign regulations and guidelines
    Experience working on CMC regulatory activities a plus
  • Demonstrated experience in the preparation and submission of INDs
  • Working knowledge of GMPs, GLPs, GCPs
  • Proficiency in MS-word, excel, PowerPoint, Adobe
  • Proven ability to plan and execute complex projects, proven record of delivering results within business-defined timeframes
  • Excellent written/verbal communication and organizational skills
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.