Chief Medical Officer for Spectrum Pharmaceuticals will possess extensive experience in advancing clinical trials successfully. With a background in Oncology or other related specialty, the successful candidate will bring a robust knowledge of Protocol design, experience in working with Key Opinion Leaders and overseeing, implementation and execution of a successful clinical trials to the position. The candidate will be a strong leader and strategic thinker with a background in a high productivity environment.
- Supervises and directs the activities of other Clinical Research staff to include Biostatistics, Data Management, Clinical Operations, Regulatory and Medical Affairs.
- Responsible for clinical development strategies including Phase I through III, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies, and interactions with corporate partner(s).
- Leads and oversees the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.
- Ensures the consistent application of state-of-the-art scientific and ethical methods to design clinical investigational trials of the highest quality.
- Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical trial implementation.
- Ensures the work with colleagues and collaborators are coordinated and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.
- Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
- Ensures the identification, recruitment and selection of appropriate clinical investigators and contract research organizations, resulting in appropriate negotiation of contracts.
- Ensures timely medical review and reporting of adverse events.
- Assists Regulatory Affairs to ensure the timely preparation of documents to be submitted to the FDA and other health authorities for review.
- Ensures the timely preparation of presentations reporting results of clinical trials to internal and external audiences.
- Collaborates with colleagues in discovery research and preclinical development line functions to move product candidates for entry into clinical investigations.
- May represent the Clinical Research line function on multidisciplinary project teams.
- Participates as an active member of the executive team of the company.
- Works with marketing to evaluate product candidates, determine product indications and design post-marketing studies, as appropriate.
Skills, Education and Experience:
- MD, MD/PhD with 10+ years of experience in investigational drug development.
- Experience in a related therapeutic specialty such as Oncology, Hematology other related specialty.
- Pharmaceutical industry experience in the successful development, registration and commercialization of new drug products is preferred.
- Experience in pharmaceutical or biotech industry working with Phase I - III clinical trials, and/or serving as principal investigator with a background in clinical trial design and protocol development.
- Familiarity with ICH guidelines and FDA requirements.
- A working knowledge of biostatistics as relevant to the design and analysis of clinical trials.
- Prior experience at senior levels working in and/or leading cross-functional teams.
- Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
- Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style
- Must be available to work in the evenings and weekends, as required.
Position Location and/or Territory and Travel
- Position is located in Irvine, CA or Henderson, NV.
- Position will require up to 25% travel.