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

Medical Science Liaison - Southern or Western US

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. 

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.
Apply Here

Senior Director, Clinical Quality

Job Summary:

This position requires a strong leader as part of the Quality team to lead MEI Pharma’s Clinical QA function. The Sr. Director of Clinical Quality will serve as a strategic and tactical quality professional in managing compliance related to Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), Good Pharmacovigilance Practices (GPVP’s) and other related activities. Responsible for ensuring oversight of compliance with GCP, GLP, and GPVP global regulations, industry best practices, and internal policies and procedures, including designing and implementing a risk based GCP audit program. Partner with the Clinical Development and Clinical Operations organizations to provide strategic GCP, GLP, and GPVP compliance oversight for clinical studies and internal operations and drive a robust risk-based vendor management program.

Management Scope:  May require management of FTEs.

Responsibilities & Duties:

  • Lead MEI Pharma’s Clinical QA function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives and represent Quality.
  • Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
  • Directly interface with Clinical Development and Clinical Operations for GCP audits of internal processes. Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
  • Partner externally to perform effective audits of vendors (CROs), investigator/clinical sites, and ensure documents are tracked and maintained within standards (e.g. Trial Master Files, Clinical Study Reports, Protocols, etc.).
  • Work with Clinical Operations and Regulatory Affairs to review IND and NDA submissions to ensure data and documents meet GCP guidelines.
  • Perform GCP training of internal company employees.
  • Planning, coordination, control, and continuous improvement of processes and systems to assure the quality of clinical studies. Provide input and change management for quality improvements affecting CQA processes.
  • Create, maintain, and revise CQA SOPs and documents that support the Quality Management System.
  • Development and implementation of GCP-related Quality Management System processes. Oversee audit plans and activities actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance.
  • Lead the GCP, GLP, and GPVP inspection management program, including inspection readiness activities, inspection conduct, and preparation of responses to health authorities.
  • Assess new and emerging regulations and applies in a fit for purpose manner to MEI’s Quality Management System and practices.
  • This position requires travel up to 25%.
  • Other duties as assigned.

Minimum Requirements

The position requires a BS or BA degree or equivalent in a science or health care field and significant experience in an FDA-regulated environment. Minimum of 15 years of experience in the pharmaceutical industry with a GCP focus, ideally covering all clinical phases through commercial drug product, with at least 5 years in a GCP quality/compliance role. Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GLP and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations. Experience conducting quality audits of CROs and Investigational sites. Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. Demonstrates initiative and proactively provides collaborative support to the clinical team as a credible communicator. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks. Continuously demonstrates a positive, ‘can do’ and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy. Ability to plan and organize work in an efficient manner, multi-task and shift priorities quickly while working under time constraints. Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development. Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

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.
Apply Here

Senior Director, Marketing – New Products

Job Summary:

The role will be responsible for building and managing the New Product Planning Team for MEI Pharma Inc. (MEI). This role will be accountable for providing cross functional strategic commercial insights that will inform product development team decisions for all pipeline assets.

On an ongoing basis the position will be responsible for establishing partnerships with R&D and Clinical in designing pre-clinical, clinical, lifecycle studies and trials to ensure differentiation-impacting decisions are driven commercially to ensure development of innovative, differentiated products that meet unmet needs.

Role & Responsibilities:

  • Lead initiatives to continually assess the commercial values, competitive landscapes and market differentiations (incorporating KOL advice) of the early assets and develop and communicate commercial priorities for resource allocation and decision making.
  • Lead and execute market research, analytics and forecasting as needed to inform strategic plans, tactics and executive level decision making.
  • Develop strategic and tactical plans that describe the progression of activities including TPP development, early positioning, segmentation, KOL identification and mapping, medical communication & education, INNs and brand naming etc.  Execute on planned activities as development timing requires.
  • Develop and own relationship with relevant KOLs.
  • Develop and manage annual budgets, long range plans and determining the best allocation of global resources for the pipeline.  
  • Work with legal, regulatory, medical affairs, corporate communications, clinical development, and translational medicine to ensure global alignment of the proposed commercial strategy.
  • Work with Market Access, Patient Advocacy, Medical and HEOR to develop differentiation strategies and compelling value proposition to secure appropriate market access.
  • Accountable for directing competitive intelligence.
  • Support Business Development in identifying and evaluating potential in-licensing, out-licensing and partnership opportunities. 

Qualifications:

  • Bachelor’s degree in life sciences or Marketing required, MBA preferred
  • Excellent verbal and written communications skills are necessary as well as attention to detail and technical aptitude
  • Executive director level requires at least 15 years of pharmaceutical experience with at least 10 years in pharmaceutical Marketing, 3 of which should be in New Product Marketing
  • US and Global biopharmaceutical marketing experience required
  • Previous product/indication launch experience required
  • Oncology experience required
  • Demonstrated track record of commercial success in positions with progressive responsibilities

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment 
  • 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, supplies and files as needed
  • Vision requirements include: close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Sr. Manager of Safety Pharmacovigilance

Job Summary:  Report to the Senior Vice President, Clinical Development. Responsible for managing and overseeing drug safety/pharmacovigilance vendor(s) and CRO(s), ensuring safety functions and deliverables are of high quality in accordance with the master service agreement, quality agreement and applicable statement of work. This position will lead the development and maintenance of pharmacovigilance/safety related plans with partners and CROs including RMPs, safety management plans, regulatory reporting plans, SOPs, literature searches and SAE reconciliation.

This position will coordinate activities between safety/PV vendors and internal MEI Pharma groups for clinical trials investigator sponsored trials; support the planning and review of aggregate safety reports; and provide guidance and support to project development teams for safety-related areas including protocol development, updates to investigators brochures, informed consent forms and study conduct as required.

Role & Responsibilities:

  • Responsible for the development, implementation of maintenance of procedures to ensure compliance with FDA and international regulations and guidance’s, as applicable.
  • Provide training to company employees, contractors and service providers as applicable.
  • Service as the main point of contact for AE/ADE reporting, drug safety evaluation and pharmacovigilance activities.
  • Responsible for the operational aspects of MEI Pharma Safety Department.
  • Ensure all reporting is completed within the required timeframes.
  • Responsible for the synthesis of safety related documents, safety data collection forms & templates for the Regulatory department.
  • Participate in interdepartmental, team, and other meetings as necessary.
  • Apply safety concepts (FDA, ICH, other international guidelines) to daily functions.
  • Perform other safety/PV operations-related tasks as necessary.
  • Ensure accuracy of MedDRA coding of adverse events and medical history.
  • Responsible for project timelines and management of reporting to FDA as needed.
  • Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations.
  • Participates with all disciplines within the organization to obtain and/or provide information for AE and PV related filings.

Qualifications:

  • Excellent written and verbal communication skills.
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight.
  • Basic knowledge of medical terminology.
  • Strong knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
  • Excellent time management skills.
  • Demonstrates professionalism and presents a positive image of the company.
  • Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
  • Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
  • Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
  • Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
  • Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.

Job Requirements and Education

  • A minimum of 5 years’ experience in Drug safety or Pharmacovigilance with at least 3 years of hands-on experience in serious adverse event management in clinical trials
  • RN, BSN, RhP, PharmD  with ≥5 years of industry experience. Masters in relevant clinical field will be preferred
  • Demonstrated competency within a Safety Database; ARISg or ARGUS (Previous experience within an EDC system is desirable)
  • Computer literacy and experience working with Microsoft Office (Word, Excel) required
  • Prior experience performing safety case data entry preferred
  • Prior experience with mentoring/training of staff (for senior level)
  • Excellent verbal and written communication skills required
  • Excellent interpersonal and organizational skills required
  • Ability to work independently, prioritize effectively and work in a matrix team environment required
     

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment.
  • 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, supplies and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.
Apply Here

Sr. Manager/Assoc. Director, Biostatistical Programming

Job Summary: The Senior Manager/Associate Director of Biostatistical Programming at MEI Pharma will lead all programming-related activities on multiple concurrent projects and oversee development of clinical study related deliverables and timelines for programming activities.

Role and Responsibilities:

  • Oversee CRO activities and review CRO deliverables
  • Monitor, analyze and report clinical trials data and generate outputs (Tables, Figures and Listings) according to study SAPs or ad-hoc request specifications in support of annual safety reports, study CSRs, regulatory submissions, business development activities and clinical publications
  • Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders 
  • Perform quality control checks/validation of advanced SAS code and output produced by CROs for SDTM datasets, AdaM datasets, TFLs
  • Create and maintain documentation for analysis dataset specifications and validation
  • Review and make recommendations for process development and improvement
  • Provide technical leadership and guidance for programming team and CRO
  • Collaborate with cross-functional teams including Data Management, Clinical Operations, and Medical Monitoring at MEI and CROs to review eCRF design and specifications, edit checks, data validation specifications, perform document user acceptance testing (UAT) on databases, and conduct clinical data quality reviews by providing SAS checks to verify integrity and consistency for completeness, accuracy, and suitability

Qualifications:

  • Excellent written and verbal communication skills.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight.
  • Excellent time management skills.
  • Demonstrates professionalism and presents a positive image of the company.
  • Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
  • Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
  • Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
  • Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
  • Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.

Job Requirements and Education:

  • Master’s degree in statistics, computer science or a related field with at least 7 years or Bachelor’s degree in statistics, computer science or a related field with at least 10 years of SAS programming experience in the pharmaceutical or biotech industry
  • 2 years + oncology experience preferred
  • Proven ability to manage CRO relationships and oversees programmed deliverables
  • Advanced skills in SAS programming and statistical reporting
  • In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements
  • Advanced knowledge with FDA and ICH regulations and guidelines, medical terminology and clinical trial methodologies
  • Good communication skills
  • Prior leadership and/or management experience

Employment type

Full time 

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment.
  • 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, supplies and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

 

Apply Here
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.