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 commitement 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
We are currently seeking applicants for the following open positions. If your qualifications match the job requirements, please submit your resume for consideration to firstname.lastname@example.org.
Medical Director, Clinical Hematology-Oncology
Under the supervision of the Senior Vice President, Clinical Development, the Medical Director plans and executes the clinical study design, protocol development, implementation and monitoring of the company’s Phase I/III Oncology/Hematology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures.
- 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.
- Medical Doctor (MD) with experience in malignant hematology and/or solid tumors required; recent experience in lymphoid and/or myeloid malignancies preferred.
- 4-8 year’s clinical development experience in the pharmaceutical or biotechnology industry (depending on title or degree)
- Phase I–III clinical trial experience preferred
- Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts
- Working knowledge of the IND/NDA process
- In depth knowledge of GCP/ICH guidelines
- Strong written and verbal communication skills (fluency in written and verbal English) as well as proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
- Leadership skills including a collaborative and team-oriented approach
- Good organizational, time management and interpersonal skills, proficiency in computer and software skills
- Experience with regulatory submissions is an asset
- Available for some travel, including overnight stays
Associate Director, Clinical Operations
Associate Director, Clinical Operations
MEI Pharma, Inc. is seeking an experienced, highly motivated professional to successfully coordinate and manage operational activities associated with a clinical development program, comprised of multiple clinical studies. This person will be a lead member of the clinical operations team whose work enables the Company to meet defined goals for the clinical development program. He/she will be responsible for the oversight of a clinical trial or suite of clinical trials from protocol design to the final clinical study report – utilizing best practices in order to ensure budgets, timelines and performance requirements are met. The position is responsible for overseeing and coordinating the efforts for the trials within the Company, through a wide variety of vendors, as well as with participating clinical investigators. The Associate Director Clinical Operations collaborates cross-functionally with peer groups at various management levels and senior management to ensure proper conduct and timely completion of the assigned clinical program.
Essential/ Primary Duties, Functions, and Responsibilities
- Assist in developing, maintaining and tracking clinical program plans including timelines, budgets and resource requirements
- Oversee assigned clinical program budget and liaise with Finance/Accounting in communicating budget forecasting and accruals
- Develop Request for Proposals (RFPs) and define scope of services for outsourced clinical activities
- Evaluate, summarize and compare various potential vendors’ proposals (e.g., CROs’ study proposals), including scope of services, budgets and timelines
- Coordinate CRO/vendor selection process activities, seeking input from other internal functional groups
- Ensure qualification of CROs, vendors and service providers in accordance with MEI Pharma’s SOPs
- Manage CRO/vendor agreements, ensuring change orders and budgets meet defined clinical operations specifications
- Coordinate all vendors’ activities involved in the clinical trials, e.g., central lab, CROs, to ensure overall clinical program timelines and objectives are achieved
- May assist in developing protocol concept sheet (study design, entry criteria and schedule of assessments table)
- Review protocols, informed consents and CRFs and track development to completion
- Review proposed site contract/agreement templates and budget templates.
- Supervise the negotiation of investigator agreements and grants appropriate to the clinical programs. Will review and approve any variations to the proposed agreement and/or grant.
- Ensure timely and appropriate response to clinical investigator site issues or other study management problems
- Review and ensure all supportive study-related documents are completed (e.g., Study Management Plan, Monitoring Plan, Data Management Plan, Pharmacy Manual, etc.)
- Review actual trial conduct and quality at all levels (i.e., monitoring, data management)
- Manage Investigational Product (IP) supply through collaboration with manufacturing and project management
- Ensure clinical data are collected and managed in accordance with the study monitoring plan and data quality standards
- Review of Clinical Trial Master File (TNF) to ensure completeness
- Ability to collaborate, negotiate and manage competing priorities across multiple functional areas
- Ensure all functional groups provide deliverables (i.e., query generation and resolution, data base lock, study report). Inform all groups of deliverables and timeline, project developments and ensure completion according to timelines
- Contribute to the clinical content of Investigator’s Brochure (IB), Development Safety Update Report (DSUR), etc.
- Prepare high-quality reports for management on program status and issues
- Recommend and assist in implementing innovative process ideas that positively impact clinical trials and/or clinical program management
- Ensure clinical trials are conducted in compliance with applicable ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations
- Report any potential GCP violations, either internally or externally, to the Head of Clinical Operations and participate in any corrective and preventative action (CAPA) plans as appropriate
- Participate in the development and review of departmental SOPs and working practices
- Work independently, exercise appropriate judgment and coach other team members for effective communication
- Line management of one or more study managers, internal CRA and/or clinical operations associate
Education and Competency Requirements
- Bachelor degree in health or biological sciences or other scientific discipline
- Oncology therapeutic area experience strongly preferred
- Global clinical trial implementation experience strongly preferred
- Clinical Phase I, II and III experience
- Proven track record of increasing responsibility in clinical operations, successful management of clinical operations support personnel, clinical program budgets and timelines
- Minimum of 8 years clinical study management experience in pharmaceutical/CRO industry
- Direct experience in managing clinical trials and prior management of contracted resources/CROs
- Previous experience in negotiating vendor/site contracts and management of budgets
- In depth knowledge of ICH-GCP guidelines and regulations and the ability to apply them
- Strong understanding of drug development process
- Strong analytical skills and operational management with attention to detail
- Demonstrated capabilities and proven track record of problem solving skills
- Excellent communication skills (oral and written) and interpersonal skills
- Ability and willingness to travel up to 25% of time, including domestic and international travel
- Highly motivated team player willing to work and collaborate cross-functionally
- 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.
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.