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
Medical Science Liaison - Southern or Western US
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.
- 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.
- 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.
Senior Director, Clinical Quality
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.
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).
- 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.
Senior Director, Marketing – New Products
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.
- 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
- 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
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.
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.