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

Associate Director/Director Biostatistics

Job Summary:

The Associate Director/Director of Biostatistics at MEI Pharma is responsible for leading, developing and implementing statistical solutions to optimally support all phases of clinical trials, regulatory submissions, and decision makings. This person will be an integral member of the Biometrics team (including biostatistics, statistical programming, and data management) whose work enables the company to meet defined goals for the clinical development programs. The successful candidate will report to the Head of Biometrics.

Role & Responsibilities:

  • Serve as a lead biostatistician on clinical projects to develop and execute statistical strategy, design, and analyses for clinical studies
  • Interact with members of the multidisciplinary project teams
  • Oversee CROs biostatistics function and manage project timelines and budget, and review/validate vendors’ deliverables including CDISC data specifications and CSR outputs
  • Participate in NDA submissions and lead the ISE/ISS analyses
  • Collaborate with internal programmers to support publications, DSUR/IB updates, and perform ad-hoc analysis and data validation as needed
  • Provide statistical expert advice and utilize advanced analytical skills to perform simulations

Qualifications:

  • Excellent interpersonal and communication skills
  • Ability to use SAS to perform efficacy and safety analyses
  • Solid knowledge of FDA/EMA guidance
  • Knowledgeable in CDISC standard

Job Requirements and Education:

  • Advanced degree in Statistics/Biostatistics (PhD preferred)
  • 8 years or more of direct hands-on pharmaceutical experience
  • Experience of NDA/BLA is a must
  • Experience of oncology is highly desired

Employment type

Full time

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

Associate Director/Director Pharmacovigilance

Job Summary:

Responsible for ensuring that the safety monitoring of MEI drugs, either managed internally or outsourced to vendor(s)  run efficiently and all activities are completed accurately in accordance with the world-wide regulatory requirements, master service agreement, quality agreement, and applicable statement of work.   Manage drug safety/pharmacovigilance (DSPV) vendor(s) and CRO(s), assuring safety functions and deliverables are of high quality in accordance with the world-wide regulatory requirements, master service agreement, quality agreement, and applicable statement of work.  Assist the Head of Drug Safety with the maturation and further development of the DSPV function at MEI, taking on the role of intradepartmental liaison and tactical leader of the function.

This position will support activities between internal MEI Pharma groups and safety/PV vendors for company-sponsored trials; lead Safety Management Team(s) (SMT) review safety reports and assist the Head of DSPV in provision of Good PVG mediated guidance.  This direction may be given to project development teams for safety-related areas including protocol development, updates to investigators brochures, informed consent forms, and study conduct as required.

This position will collaborate with and/or in some cases manage DSPV consultants; the successful candidate will eventually manage some DSPV direct reports.

  Role & Responsibilities:

  • Responsible to implement and maintain policies, processes, and procedures to ensure compliance with FDA and international regulations and guidance
  • Responsible for the operational aspects of MEI Pharma Safety Department, including metrics tracking
  • Maintain informational and quality trackers, as needed and takes an active role in addressing
  • Provide safety training as needed and eventually develop and managed SDPV’s
  • Maintain and review department status reports, keep Head of DSPV apprised of any potential/actual study or staffing issues, and assist with developing solutions
  • Assure all project safety activities are completed in accordance with SOPs, SSPs, and other applicable regulations
  • Accountable for project timelines and management of reporting to the FDA as needed.
  • Leads one or more Product-specific SMTs and assists Head of DSPV with Safety Governance at MEI
  • Takes ownership of application of Quality process within the function, taking a lead role for inspections etc

Qualifications:

  • Comprehensive knowledge of EMA, FDA PV regulations as well as GPV rules/practices 
  • Familiarity with PMDA regulations a plus
  • 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, time management 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
  • Strong knowledge of the clinical research process and current GCP/ICH guidelines applicable to the conduct of clinical research
  • Demonstrates professionalism and presents a positive image of the company
  • 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 and welcomes the opportunity to grow and adapt
  • Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect

Job Requirements and Education:

  • A minimum of 10 years of experience in Drug Safety and Pharmacovigilance in the industry (biopharma and/or CRO) with at least 3 years at a management level
  • Medical/Graduate degree, such as MSN, BSN, PharmD or RPh or equivalent
  • Prior experience with mentoring/training of staff
  • Demonstrated competency within ARGUS,
  • Computer literacy and experience working with Microsoft Office (Word, Excel) required

Employment type

Full time 

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 the ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Contracts Attorney

Job Summary: This person will work closely with the legal department personnel, along with all departments to negotiate and draft contracts with various third parties including vendors and clinical trial sites. This position requires experience negotiating and drafting contracts typically entered into by a life science company as well as clerical and analytical skills to support the contracts functions.

Role & Responsibilities:

  • Draft, review, and negotiate contracts, including CDAs, MSAs, consulting agreements, clinical trial agreements, and other clinical documents, independently and with minimal supervision
  • Assist the legal group in various tasks related to the management of contracts
  • Other duties as directed by the legal group

Qualifications:

  • Must have experience with CTAs, ICFs, and LOAs, as well as a variety of other types of contracts such as MSAs, CDAs, SOWs, MTAs, etc.
  • Strong knowledge of the clinical research process
  • Excellent written and verbal communication skills
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute 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
  • Excellent time management skills
  • Demonstrates professionalism and presents a positive image of the company
  • Prioritizes time effectively based on project needs. Consistently meets deadlines
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability, and flexibility with changes in responsibilities and duties
  • Demonstrates honesty and integrity in dealing with others work effectively with different types of people and accepts constructive feedback without becoming defensive
  • Seeks input from others when faced with a difficult situation, make sound decisions within the scope of responsibility, and focuses on resolving problems rather than placing blame
  • Establishes and maintains effective relationships with clients (internal and external) and gains their trust and respect provides clients with complete and accurate information and acts with the client in mind

Job Requirements and Education

  • Juris Doctorate degree with 5+ years of experience in the pharmaceutical or biotech industry
  • Experience in MS Office product (Excel, PowerPoint & Word) and Adobe
  • Self-directed nature, ability to work independently with minimal supervision, and ability to follow directions, is detail-oriented and can multi-task
  • Self-motivated and able to organize and prioritize multiple tasks
  • Excellent interpersonal, verbal, and written communication skill

Employment type

Full time

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
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Contracts Specialist Paralegal

Job Description

Job Summary: This person will work closely with the legal department personnel, along with all departments to administer the company’s patent estate as well as negotiate and draft contracts with various third parties including vendors and clinical trial sites. This position requires experience negotiating and drafting contracts typically entered into by a life science company as well as clerical and analytical skills to support both contracts and patent functions.

Role & Responsibilities:

  • Draft, review, and negotiate contracts, including CDAs, MSAs, consulting agreements, clinical trial agreements, and other clinical documents, independently and with minimal supervision
  • Provide support to the patent function that includes managing and maintaining a patent docket and patent portfolio. Primary interface for outside patent counsel. The patent responsibilities for this position are administrative. The company’s General Counsel and outside patent counsel are responsible for patent strategy and prosecution
  • Assist the legal group in various tasks related to the management of patent and contracts
  • Assist in the management of public disclosures and publications as it relates to IP rights
  • Other duties as directed by the legal group

Qualifications:

  • Must have experience with CTAs, ICFs, and LOAs, as well as a variety of other types of contracts
  • Must have knowledge of patent and contracts terminology
  • Strong knowledge of the clinical research process
  • Excellent written and verbal communication skills
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute 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
  • Excellent time management skills
  • Demonstrates professionalism and presents a positive image of the company
  • Prioritizes time effectively based on project needs. Consistently meets deadlines
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability, and flexibility with changes in responsibilities and duties
  • Demonstrates honesty and integrity in dealing with others.
  • Work effectively with different types of people and accepts constructive feedback without becoming defensive
  • Seeks input from others when faced with a difficult situation, makes sound decisions within the scope of responsibility, and focuses on resolving problems rather than placing blame
  • Establishes and maintains effective relationships with clients (internal and external) and gains their trust and respect.
  • Provides clients with complete and accurate information, and acts with the client in mind

Job Requirements and Education

  • Bachelor’s degree or associates with 10 years in the pharmaceutical or biotech industry
  • Experience in MS Office product (Excel, PowerPoint & Word) and Adobe
  • Self-directed nature, ability to work independently with minimal supervision, and ability to follow directions, is detail-oriented and can multi-task
  • Self-motivated and able to organize and prioritize multiple tasks
  • Excellent interpersonal, verbal, and written communication skill

Employment type

Full time

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
  • Vision requirements include close vision and the ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Director, Clinical Data Management

Job Summary:

MEI Pharma, Inc. is seeking an experienced, highly motivated professional as the Head of Clinical Data Management function. This person will be an integral member of the Biometrics team whose work enables the company to meet defined goals for the clinical development programs. The Head of Clinical Data Management collaborates with other functional peer groups at various management levels and senior management to ensure proper conduct and timely completion of all projects, as applicable. The successful candidate will report to the Head of Biometrics.

Role & Responsibilities:

  • Lead a team of high performing clinical data managers to meet business objectives
  • Oversee all data management activities and deliverables
  • Act as a core member of the study team and provides CRO oversight for end-to-end Data Management activities, and monitor DM deliverables
  • Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews)
  • Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
  • Support the development of the clinical components of regulatory submissions
  • Perform data review, and lead internal cross-functional team review on clinical data on an ongoing basis per Data Review Plan
  • Develop Vendor Management Plans, monitor vendors’ quality performance based on pre-defined quantitative or qualitative metrics
  • Manage competing for data management priorities across multiple studies
  • Develop and maintain appropriate data management SOPs

Qualifications:

  • Strong working knowledge of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations
  • Excellent communication skills (oral and written) and interpersonal skills
  • Strong analytical and problem-solving skills

Job Requirements and Education:

  • Bachelor’s degree in Life Science, mathematics, or health-related fields
  • Minimum of 12 years of data management experience in the pharmaceutical/biotech/CRO industry
  • At least 2 years of oncology therapeutic area experience
  • Experience supporting eCTD submissions required

Employment type

Full time

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 the ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Medical Science Liaison- US (Midwest)

Job Summary: Reporting to the Director of Medical Affairs, the Medical Science Liaison (MSL) is a field-based member of Medical Affairs who develops and enhances professional relationships with medical thought leaders, investigators, and key medical organizations.  The MSL identifies collaborative opportunities with key thought leaders and provides medical information through medical/scientific discussions and presentations in a balanced, non-promotional manner.  This is research-focused and a highly visible role within the MEI team. It is a challenging position in a fast-paced setting that requires a highly motivated, self-starter.  The role is performed in accordance with all applicable legal, regulatory and professional guidelines. 

 Role & Responsibilities:

  • Identifies specific oncology Key Opinion Leaders (KOLs), establishes and maintains scientific relationships with KOLs, and identifies opportunities for collaborations 
  • The MSL ensures the appropriate dissemination of clinical and scientific information regarding MEI's oncology pipeline compounds
  • Collaborates with the in-house Clinical Operations and Clinical Development teams to enhance patient enrollment in company-sponsored clinical trials, identify appropriate clinical trial sites, and provide clinical and scientific updates to investigators in ongoing studies
  • Contributes to regional and national/international congress strategies
  • Provides scientific and medical support at national/international congresses and regional medical meetings
  • Develops succinct summaries of key information learned through medical meeting attendance and field activities
  • Contributes to the planning and execution of scientific panels and meetings
  • Provides timely feedback and information on emerging clinical trends to internal staff
  • Facilitates and manages investigator- initiated studies
  • Contributes to publication planning and other medical communications activities
  • Ensures all activities are compliant with MEI’s company policies

Qualifications:

  • Flexibility to adapt to changing priorities
  • Respectful, accountable and collaborative
  • Ability and desire to work in a collaborative team
  • Excellent time management skills to balance multiple responsibilities and to meet deadlines
  • A solid professional reputation for interacting productively with thought leaders in the field
  • Able to spend a significant amount of time in the field

Job Requirements and Education:

  • Advanced scientific degree (PhD, PharmD, DSc) with at least 3 years of Hematology/Oncology MSL experience
  • Lymphoma experience is strongly preferred
  • Excellent presentation and communication skills
  • Strong understanding of clinical and scientific data
  • An understanding of the oncology drug development process
  • Ability to create materials such as reports and presentations for internal and external groups
  • Approximately 50-60% travel is required; overnight travel required as needed
  • Must possess a valid driver’s license and a good driving record

Employment type

Full time 

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

Quality Assurance Manager

Job Summary: Reporting to the Director of Quality Assurance, the Quality Assurance Manager is responsible for quality oversight of daily operational activities at contract manufacturing, packaging/labeling and testing facilities for products and services that support clinical studies (phase I through phase III) and products that meet commercial requirements. The position will provide quality guidance and work with MEI internal departments to ensure all applicable regulatory requirements and company quality management system requirements are met.   

Role & Responsibilities:

  • Primary QA contact with external vendors that manufacture, test, package, label, and/or distribute product or provide services for GMP activities.  Responsible for quality approval of vendor generated documents – e.g., analytical methods, method validation protocols/reports, process validation protocols and reports, specifications, master batch/packaging records, label proofs, deviations, CAPA and change controls.
  • Quality reviewer of executed batch/packaging records, product testing records (in-process, release, and stability), deviations, investigations, stability protocols/reports, method/process validation documentation, reference standard requalification documentation, certificates of analysis, certificates of compliance.  Ensures all materials are manufactured in compliance with applicable regulations and MEI regulatory submissions.
  • Dispositions drug substance\drug product batches and work-in-process materials for use in downstream manufacturing operations, dispositions final products for clinical or commercial use. Provides approval for shipment of product.
  • Tracks and monitors internal open Deviations, Investigations and CAPA to closure in compliance with company procedures.
  • Assigns appropriate expiration/retest dates on MEI investigational materials/products. 
  • Addresses shipping and storage temperature excursion notifications related to investigational products.
  • Provides quality approval of new and revisions to existing MEI controlled documentation – e.g., SOPs, Forms, and Specifications.
  •  Receives, initiates and oversees investigation into product complaints for Investigational products.
  • Provides guidance and support as a Quality representative on internal project teams.
  • Tracks, evaluates and approves changes made to products, processes and GMP vendors.
  • Collects, reviews and reports on Quality Metric data for Management Review purposes.
  • Other QA activities may be performed as required.

Job Requirements and Education:

  • Bachelor’s degree in a scientific/technical discipline with 10+ years’ pharmaceutical experience, or an equivalent combination of education and experience with expertise in the following:  
  • Operation within a virtual manufacturing environment.
  • Current FDA, EMA, PMDA regulations and ICH guidances concerning the manufacture and testing of investigational and commercial products. 
  • Risk-based decision-making processes. 
  • Business, scientific, and personal computer hardware and software applications (MS Word, Excel, Access, Outlook, Adobe Acrobat) as well as with Electronic Data Management Systems.  Experience with MasterControl desirable.
  • High level of professionalism and collaboration in team settings. A willingness to adapt to changing situations.
  • Experience in Drug substance or Drug product manufacturing desirable.
  • Well-developed communication skills – written and verbal.
  • Ability to work independently.
  • Ability to manage tasks with competing priorities or deadlines.
  • Successful experience in fast-paced entrepreneurial environment.
  • This is an office-based San Diego position with a potential for travel as needed.

Employment type

Full time 

ADA Notations:

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

Job Summary:

The Sr. Director of Quality Control will serve as a strategic and tactical quality professional in ensuring oversight and execution of all aspects of GMP related analytical testing. Responsible for ensuring oversight of contract laboratories and testing performed by manufacturers of all MEI products, including starting materials, in-process, release, and stability testing throughout the product lifecycle. The Sr. Director of QC supports MEI’s quality culture through collaborating externally and with internal stakeholders to ensure method transfers, method validation, expiration dating, specification setting, and QC data integrity is established and maintained for late phase and commercial programs. Responsibilities also include establishing and ensuring risk-based QC policies and procedures are maintained and followed.

 Role & Responsibilities:

  • Lead MEI Pharma’s QC function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives and represent QC.
  • Oversees CMO and contract laboratory GMP testing of reference standards, starting materials, in-process, release, and stability testing throughout the product lifecycle for all MEI programs Manages contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve if needed. Responsible for method transfers and analytical method validations for late phase and commercial testing and ensuring QC data integrity, including QC review and approval of documents
  • Establishes processes and ensures collection, analysis, assessment and approval of data to support annual product quality reviews, specifications, stability, and product quality trending.
  • Directly interface with contract laboratories, manufacturers, regulators, and GMP Quality Compliance in support of internal and external audits and inspections of MEI programs, including inspection readiness activities. Audit and inspection responsibilities include support and preparation of responses to observations and ensuring response CAPAs are effective
  • Planning, coordination, and continuous improvement of methods, processes, and systems to assure the quality of testing of MEI products. Provide input and change management for quality improvements affecting QC methods and processes
  • Development and implementation of testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and documents that support the Quality Management System
  • Ensure that the QC organization meets key performance indicator goals. Includes meeting and exceeding internal stakeholder and customer expectations
  • Builds and maintains expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities where required
  • Work with Pharmaceutical Sciences and Regulatory Affairs to review IND and NDA submissions to ensure data and documents meet GMP guidelines
  • This position requires travel up to 20%
  • Other duties as assigned

Qualifications:

  • Demonstrates initiative and proactively provides collaborative support to the internal and external stakeholders 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)

Job Requirements and Education:

  • The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, or equivalent science program
  • Minimum of 15 years of experience in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with at least 5 years in a GMP QC release testing role
  • Significant experience in an FDA-regulated environment
  • Broad knowledge of QC processes and procedures, LIMS systems, and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulations

Employment type

Full time 

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- CMC, Regulatory Affairs

Job Summary: Reporting to the Executive Director of Regulatory Affairs, the successful candidate will provide expertise in translating regulatory requirements into practical, workable plans for P1-3 stage oncology-related drugs. Candidate will have primary responsibility for activities pertaining to CMC-related submissions to, and communications with the FDA and other Health Authorities and manage the activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.

  Role & Responsibilities:

  • Provide regulatory strategic input for assigned programs in the areas of Oncology and Hematology drug development and lifecycle management
  • Provide strategic guidance to teams on the regulatory requirements to support clinical development and life-cycle management for preparation and maintenance of IND and IMPD filings as well as MEI Pharma’s first NDA. Oversee development of all regulatory filings in support of program
  • Evaluate and advise on regulatory risk in collaboration with teams, assess/manage critical analyses of data (with a special emphasis on manufacturing), independently develop interpretations and conclusions. Strategic and accuracy review of CMC Module 3 documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements
  • Lead interdepartmental teams in the authoring of high-quality regulatory communications such as regulatory briefing packages
  • Regulatory lead for cross-functional collaborative CMC regulatory projects
  • Oversee and ensure compliance with regulatory procedures and work practices
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risk
  • Train and mentor regulatory personnel on strategic matters, related to company and external information. Maintains a positive team spirit and leads by ethical principle

Qualifications:

  • Strategic thinker, planner, and implementer with excellent organizational skills
  • Excellent written, verbal, influential, collaborative and interpersonal skills
  • Capable of critically reviewing complex technical/scientific documents and ability to execute
  • Thorough understanding of relevant regulations and guidelines, including ICH, FDA, and EMA for the development of small molecule products
  • Demonstrated experience with IND, IMPD, and NDA submissions
  • Ability to make sound decisions in complex situations
  • Detail-oriented and results-driven
  • Proficiency in MS-word, Excel, PowerPoint, adobe

Job Requirements and Education:

  • At least a Bachelor's degree in a scientific discipline, Masters preferred with a minimum of 10 years of experience in Regulatory Affairs
  • Experience with pharmaceutical and clinical development of small molecule NCEs (in Oncology and Hematology desired)
  • Proven ability to plan and execute complex projects, proven record of delivering results within business- defined timeframes
  • Experience leading and coaching staff
  • Expert knowledge of FDA and foreign regulations and guidelines
  • Demonstrated experience in the preparation and submission of INDs, IMPDs, NDAs
  • Knowledge of GMPs, GLPs, GCPs

Employment type

Full time 

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 Manager, CVS/Quality Risk Management

Job Summary: Reporting to the Director of Quality Assurance, the Senior Manager, Computer System Validation/ Quality Risk Management is responsible for the improvement, design, development, and implementation of the GxP QMS computerized system and software management processes at MEI.  This includes, but is not limited to, Computer Systems Validation, Risk Management, Computer System Vendor Management, and Quality Agreements with GxP computer system and software providers.  The role is focused on improving and maintaining GxP computerized system business processes, implementation, and release management of GxP systems and may include leading the implementation of GxP upgrades and improvements of IS solutions/systems.   The Senior Manager will also support MEI’s Quality Risk Management program by maintaining the GxP risk register, facilitation of risk assessments, and education of the risk program across GxP functions.

  Role & Responsibilities:

  • Lead the development and continuous improvement of the Computer System Validation process at MEI.
  • Validation Lead for the implementation of critical business solutions (e.g., ERP, eDMS, eLMS, CAPA, Audits, etc.).
  • Audit computer system software, SAAS and IT Outsource service vendors, as necessary.
  • Provide compliance leadership, direction, and oversight in the area of Computer System Validation.
  • Responsible for the quality assurance oversight of GxP regulated computerized systems.
  • Develop and maintain computerized system life cycle documentation:  user requirement specifications (URS), functional requirement specifications (FRS), design specifications, risk analysis, traceability matrices, standard operating procedures, installation qualification protocols, operation qualification protocols, performance qualification protocols, validation master plans, and summary reports.
  • Improve, facilitate, and guide MEI internal departments through the Quality Risk Management process.
  • Implement risk-based approaches.
  • Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes.
  • Establish and track quality metrics for risk management and computer processes and present improvement opportunities at Management Review meetings.
  • Ensure compliance to regulatory expectations and ensure the Quality Management System supports inspection preparedness.

 

 Qualifications:

  • Experience in implementation of an Enterprise Resource Planning (ERP) solution, electronic Document Management System (eDMS), electronic Learning Management System (eLMS), electronic CAPA solutions and/or other GxP computer systems.
  • Direct experience with managing other key Quality Management System processes (e.g., Change Management, Vendor Management, Deviations/CAPA, Quality Risk Management).

 

Job Requirements and Education:

  • Bachelor’s degree in an engineering, mathematical or scientific/technical discipline with a minimum of 8 years’ experience in a GxP environment or validation of IT applications, or an equivalent combination of education and experience.
  • Prior management or direct experience working with Computer Systems Validation.
  • In-depth understanding of GAMP 5, 21 CFR Part 11, EudraLex Vol 4, Annex 11, ICH and current global regulatory expectations.
  • Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results.
  • Technical proficiency, attention to detail, creativity, innovation, and independent thought.
  • Strong professional interpersonal and communication skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders, and management.
  • Ability to meet deadlines and multi-task efficiently.
  • Comfortable in a fast-paced environment with minimal direction and changing priorities.
  • Experience identifying changes, driving improvements, and streamlining processes.
  • Proficient with Microsoft Office Suite, Word, Excel, PowerPoint, and Project.

 

Employment type

Full time 

 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting 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 Manager, Financial Planning & Analysis

Job Summary: The Senior Manager, Financial Planning & Analysis to manage short-term and long-term financial planning including annual budgeting and long-term forecasting and modeling, as well as other areas of finance and analysis.  The position will report to MEI Pharma’s Executive Director, Finance and will work closely with other members of MEI Pharma’s Finance and Accounting team, as well as other functional areas especially the clinical team and alliance management team.  There is currently no staff reporting to this position, therefore it is a hands-on management role.

Role & Responsibilities:

  • Plan and coordinate the annual budget process, long-term forecast, periodic re-forecasts and on-going projections.
  • Provide regular reporting and variance analyses to R&D function and cost center managers to enable decision making and alignment to company objectives.
  • Provide budget versus actual analyses to alliance partners with whom we have collaborative cost-sharing arrangements.
  • Work closely with clinical operations in order to develop budgeting and long-term forecasting related to clinical trials and related expenditures and collaborative arrangements with alliance partners.
  • Prepare, review and analyze financial reports, presenting operating results and budget variations for Executive Management.
  • Forecast and manage cash flow and assist in managing cash investments to maintain appropriate liquidity for the company.
  • Provide financial analysis and presentations for Audit Committee, Board of Directors, press releases, alliance partners, and investor packages.
  • This is a hands-on management position.
  • Identify and implement process development and improvements relating to budgeting, forecasting, period close process, ERP implementation, and financial reporting.
  • Participate in other ad hoc projects, roles, and workload sharing between Finance and Accounting as appropriate.
  • Other related duties, as assigned.

Qualifications:

  • Strong communication skills, ability to effectively interact with others at all levels– within and outside of finance. Ability to tailor communication to the audience to achieve desire results.
  • Self-starter with the demonstrated ability to work in a fast-paced atmosphere with minimal supervision.

Job Requirements and Education:

  • Bachelor’s degree in Finance/Accounting, CPA/MBA preferred.
  • 7+ years’ experience in accounting, financial reporting/analysis or related field preferably in the biotechnology or pharmaceutical industry.
  • Experience with building financial models for clinical trials a strong plus.
  • Highly proficient in Microsoft Excel, with experience building models.
  • Experience utilizing enterprise-grade, commercial ERP systems and reporting software; Netsuite and Adaptive experience a plus.
  • Ability to gather, analyze and interpret information for completeness and accuracy; excellent attention to detail; excellent organizational skills.
  • Experience with FP&A Planning systems preferred.
  • Working knowledge of Generally Accepted Accounting Principles (US GAAP).

Employment type

Full time 

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

Vice President, Human Resources

Job Summary:

Reporting to the Chief Financial Officer, the Vice President Human Resources will lead the Company’s Human Resource function driving employee engagement and retention enabling the Company to deliver against its goals of developing and commercializing new oncology products for patients with unmet medical needs.

The Vice President HR will create/enhance current HR programs, guidelines, and tools to deliver the highest level of HR services to employees and managers. With a strong balance of business acumen and deep HR knowledge/experience, this person will ensure HR services flawlessly delivered in an accurate and timely manner. The roles spans Talent Acquisition, Compensation, Performance Management, Employee Engagement, Benefits, Employee Safety/Compliance, and HR operations. The VP will be part of the Finance Leadership team and be responsible for managing an HR Assistant as well as a variety of external vendors and resources. The role is based at MEI headquarters in San Diego.  

  Role & Responsibilities:

  • Drive business results by creating/implementing best practice human resource initiatives tailored to business requirements and legal guidelines
  • Act as an influential advisor and a credible agent identifying and driving change by owning end to end execution of the functional HR work; act as a thought partner for leadership to ensure the people and organization strategy is a key enabler to achieving the business results
  • Develop and implement a Talent Acquisition strategy including identifying resources to meet the Company’s talents needs; develop, negotiate, and close candidates 
  • Manage the compensation infrastructure for executive and non-executive cash and equity compensation; manage the timely submission of salary survey input
  • Work with clients to implement and manage human resources processes, including the year-end performance management process
  • Manage and administer the Company’s benefits offerings; manage external benefits provider
  • Identify and implement hard and soft skill training; ensure safety and compliance training is delivered and monitored on a timely basis
  • Act as coach/mentor/advocate for employees and managers; resolve employee relations issues and develop pro-active solutions based on root-cause trend analysis
  • Ensure the business develops and retains high-quality talent at all levels in a continuous pipeline to support the growth objectives, opportunities, and strategies of the business
  • Ensure employee files and records are maintained in a compliant manner

Qualifications:

  • Self-motivated and self-confident; comfortable operating with minimal direction; thrives in a dynamic environment as a leader influencing change and transformation
  • Success quickly building credibility among senior management and peers to gain commitment and support for major initiatives while placing the company’s interests first
  • Unquestioned personal and business integrity who will be viewed as trustworthy by both managers and employees
  • A mission-driven individual with high energy and strong levels of perseverance; works toward both individual and team goals
  • Reputation for rolling up one’s sleeves to do whatever it takes to drive results; not hindered by protocol or process
  • Excellent verbal and written communication, interpersonal and influencing skills; proven success working in a multi-functional, team-based environment and with external thought leaders

Job Requirements and Education:

  • Bachelor's degree in industrial/organizational psychology, human resource management, business, or a related field
  • 7+ years of experience in progressively responsible roles in human resources, including human resources business partner or “generalist” with deep experience in Talent Acquisition, Performance Management, Employee Relations/Engagement and Compensation
  • Solid experience in a biotech or pharma company
  • A credible and savvy businessperson who will be perceived as a trusted consultant and functional expert to senior management
  • Knowledgeable in leading-edge business practices, trends, and information; aware of reward and benefits strategies and innovative tactics being applied in the marketplace
  • In-depth team management skills, reputation for leading, training, mentoring, and retaining team members at all levels; prior success leading other HR professionals
  • Record of working independently under general supervision; demonstration of exercising excellent judgment/decision making, sometimes without complete information within generally defined practices and policies
  • History of success working work collaboratively across the organization and with international partners achieving corporate objectives
  • Adept, nimble, successful/comfortable in fast-paced, dynamic, collaborative environments

Employment type

Full time 

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 the 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.