Director, Clinical Development
Under the supervision of the Vice President of Clinical Development and Medical Affairs, the Clinical Development team member drives and executives the goals for the study design, plan, protocol development, implementation and monitoring of the company’s Phase I/II 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.
- 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.
- Coaching and mentoring less experienced Clinicians as assigned.
- Medical Doctor (MD) or graduate level degree preferred
- Minimum Bachelor’s level degree or equivalent experience required in a scientific or clinical discipline (Clinical Pharmacology, Nursing)
- Hematology and/or Oncology experience required
- 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
- Leadership skills including a collaborative and team-oriented approach.
- Good organizational, time management and interpersonal skills, proficiency in computer and software skills
- Available for some travel, including overnight stays
- Experience with regulatory submissions is an asset.
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
- Regular communication (hearing/speaking).
- Routine office duties including computer keyboard use and some lifting of light-weight office equipment and files as needed.
- Vision requirements include: close vision and ability to focus.
- Noise conditions range from quiet to moderate.
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.