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

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

Human Resources Director

Job Summary:

Reporting to the Chief Financial Officer, the Human Resources Director is responsible for organizing and administrating all aspects of Human Resource functions for MEI Pharma, Inc.  These duties include Recruiting, On-Boarding, Payroll and Benefits Administration, Compensation, Annual Performance Reviews, Employee Training and Safety Compliance, employee file administration, policies & procedures with all legal compliance. This position interfaces with employees at all levels and the information handled must be accurate and held strictly confidential.

Management Duties:  None at this time.

Responsibilities:

Recruitment:

  • Prepares job descriptions, confirms salary data, posts open position notices to relevant online sites, contracts with outside recruiters as needed.
  • Screens resumes, identifies appropriate candidates with staff, sets interview schedules.
  • Obtains candidate approval, generates offer letters, stock option grants, completes background checks; coordinates on-boarding with appropriate departments.

Salary Surveys and Compensation:

  • Participates in two local biotech/pharma salary surveys each year.
  • Uses data with new-hires as well as current employees during the annual Performance Review cycle.

Annual Performance Reviews (PR):

  • Leads & monitors the annual PR cycle, creating all suitable forms and managing deadlines.
  • Suggests salary adjustments based on survey data, implements approved discretionary merit and bonus increases, recognizes promotion salary increases, enters all changes into payroll system.
  • Creates employee letters that reflect all changes along with any PR stock option grants.

Payroll:

  • Creates working spreadsheet for each bi-monthly payroll with all employee changes.
  • Reviews timesheets & PTO for accuracy and enters into payroll system.
  • Provides month-end PTO accrual spreadsheets to match ADP employee summaries for Finance.

Benefits Administration:

  • Health Insurance, H S A, 401k
    • Conducts new hire orientation on benefit programs ensuring smooth enrollment by employee on all benefits’ providers websites.
    • Works with Third Party Benefits Administrator on annual benefits renewal.  Arranges for annual employee benefit meeting and 401(k) as needed.
    • Participates in annual 401k due diligence meeting with Third Party Administrator.
    • Responsible for all preliminary 401k plan testing (NDT) and medical POP.
  • Training:   When appropriate, HR provides training on the following topics throughout the year:  Safety, Performance Reviews, Benefit Updates, Changing Laws or Workplace Trends, DISC – for enhanced corporate communication.
  • Safety Administration:
    • Provides employee safety training as needed with employee sign-offs as required.
    • Schedules professional appointment for each employee’s work site to ensure ergonomic compliance.
    • Annual OSHA Accident Notice Postings, Work Comp policy renewal/audit details.
  • File Management & HR Legal Compliance:
    • Maintains all employee files/records following HR best practices’ compliance
    • Stays current on HR policies and procedures as well as legal compliance and fulfillment of HR CE units for PHR/SPHR certification.
    • Interprets and explains Company policies and procedures to employees as well as HR-related federal, state and local laws, standards and regulations as needed.
    • Reviews MEI Company Handbook on ADP on a regular basis – adding any policy/procedure changes as needed.
    • Posts annual CA and Federal law posters. 
  • Employee Relations:
    • Works to integrate new hires into MEI’s corporate culture.
    • Counsel/coaches employees regarding performance management, facilitation of complaints through to resolution, possible termination in line with business and legal compliance.
    • Emphasizes enhanced employee retention to maximize/maintain close working relationships across all departments to preserve company resources to exceed corporate goals.

Requirements:

  • Bachelor’s degree in Business or equivalent with 8+ years of experience in the biotech/pharma industry – preferable in a start-up or smaller company environment.
  • Human Resources Certification  -  PHR/SPHR preferred 
  • Finance/payroll experience – with exempt and non-exempt employees.
  • Knowledge of Federal, state and local employment laws. 
  • Strong analytical skills with working knowledge of Microsoft Word, Excel, PowerPoint and Outlook.
  • Strong attention to detail, excellent written and verbal communication skills.
  • Ability to use good judgment in sensitive situations and maintain confidentiality.
  • Commitment to excellent customer service.

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.

Legal Affairs Director

Summary

Reporting to the Chief Operating Officer and General Counsel, the Legal Affairs Director provides legal support for MEI Pharma, Inc. (MEI) primarily by negotiating and drafting agreements typical for a pharmaceutical company.  The role also includes liaison on intellectual property management and pre-marketing regulatory compliance matters.

Responsibilities

  • Provides legal support and substantive advice to MEI’s Clinical, CMC, Regulatory, IT, HR and Finance Departments.
  • Negotiates, drafts, reviews and interprets a wide range of agreements, including confidentiality, material transfer, services, consulting, sponsored research, clinical trial, and manufacturing.
  • Serves as point for pre-marketing regulatory compliance working with outside counsel and regulatory consultants as necessary.

Requirements

  • Juris Doctorate from an accredited law school and authorization to practice law in California.
  • Excellent academic and law firm credentials with at least 6 years of relevant experience handling and negotiating complex commercial contracts at a life science/pharma/biotech organization and/or a top-tier law firm.
  • Strong understanding of legal issues and risks pertaining to contract drafting and administration with significant experience negotiating, drafting and reviewing a wide variety of complex pharma-related agreements.
  • Knowledge of contract and regulatory compliance, familiarity with intellectual property law and patent portfolio maintenance (not prosecution) preferred.
  • A demonstrated ability to grasp scientific and technical concepts quickly; science background a plus.
  • Detail-oriented, able to prioritize and handle multiple tasks, and work well under pressure.
  • Superior communication and interpersonal skills with an ability to interface with all levels of MEI staff.
  • Strong organizational skills to manage multiple time-sensitive projects simultaneously; willingness to assume heavy workload to meet timing and project needs.

This is an in-house position at our San Diego office.  No relocation

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 Director

Job Summary: 

Reporting to the Senior Vice President, Clinical Development, the Medical Director will plan and execute the study design protocol development, implementation and monitoring of the company’s Phase I/III Oncology/Hematology clinical trials.  The position will provide key overall medical and scientific oversight to clinical development programs.

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 clinical hematology/ oncology and clinical research experience.
  • Significant clinical development experience with limited oncology experience will be considered as will significant oncology experience with limited clinical development experience and/or candidates with equivalent academic clinical research experience.
  • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
  • Exposure to the IND/NDA process preferred.
  • In-depth knowledge of GCP/ICH guidelines preferred.
  • Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
  • Available for some travel including overnight stays.
  • Strong written and verbal communication skills required.
  • Ability to thrive in a fast-paced small company environment with ability to adjust workload based upon changing priorities.
  • Executive leadership skills including a collaborative and team-oriented approach.
  • Good organizational, time management and interpersonal skills.

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Ability to lift regular number of office supplies/files.
  • 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 - 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 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.