CTI Biopharma is a Seattle based biopharmaceutical company focused on the development and commercialization of novel therapies that address unique unmet medical needs for patients suffering from blood-related cancers. We are committed to acting on behalf of patients courageously facing cancer, moving forward with persistence in our pursuit of creating life-changing medicines.

We are looking for an Associate Medical Director to join our fast-growing team. This job will be a remote position. While our office is in Seattle, we are open to candidates from anywhere in the United States.

SUMMARY:

The Associate Medical Director is responsible for management and review of clinical trials and product development. Specific tasks may include clinical protocol development, medical monitoring of clinical trials, analysis of study data, and preparation of trial reports and related regulatory documents. Additional roles in publication planning and writing may be included. The individual will interact with most departments within CTI to ensure the successful progress of projects and clinical trials. This position will involve representing CTI at scientific congresses, as well as at clinical and business development meetings.

Essential to success is excellent medical knowledge (particularly in malignant hematology), ability to build and maintain strong relationships with study investigators / key opinion leaders (KOLs), and outstanding internal partnerships (particularly with Pharmacovigilance and Medical Affairs).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide medical monitoring for Ph I - IV clinical trials, including patient enrollment, medical oversight of patients on study, providing guidance to investigators, review and analysis of adverse events, review of electronic data, and review of protocol deviations, protocol amendments, and informed consent forms. Initial priority will be monitoring of a Ph III clinical trial.
• Liaise with and manage external medical monitoring vendors/clinical research organizations (CROs), including oversight of CRO medical monitors.
• Collaborate on clinical development strategies for Phase I-IV programs, including review of investigator-sponsored trials.
• Providing review and input into advisory boards, educational materials, and publications.
• Work with cross-functional clinical team, including clinical operations, clinical pharmacology, pharmacovigilance, medical writing, statisticians, data management, and members of multidisciplinary project teams to guide data collection and data interpretation.
• Work with Regulatory Affairs and Pharmacovigilance to contribute to authoring and medical review of investigator brochures, safety reports, and other regulatory documents.
• Participate in company interactions with regulatory agencies.
• Must have knowledge of GCP, ICH and other regulatory requirements for evaluating and reporting adverse events, clinical trial data, clinical brochures and scientific publications.
• Travel for internal meetings or for external conferences or site visits, up to 10%.

EDUCATION/EXPERIENCE/SKILLS:

Required:

• M.D. Degree, having completed residency in Internal Medicine or Pediatrics
• Excellent medical and scientific knowledge
• Working knowledge of Hematology / Oncology, with a proven track record of interpreting, discussing, and presenting efficacy and safety data relating to clinical trials
• Excellent writing / communication skills
• Knowledge of GCP and ICH guidelines, clinical development process, and basic medical statistics

Preferred:

• Board Certified or Board Eligible in Hematology and/or Oncology (highly preferred)
• U.S. medical license
• Oncology or Hematology drug development or clinical trial experience
• Track record of scientific publications, including manuscript and abstracts

COMPENSATION AND BENEFITS:

The base salary for this position could range from $213,000 to $235,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and depth of experience. Actual compensation is also dependent upon current market data, experience, and pay parity within our organization. Full-time equivalent employees will also be eligible to participate in the total compensation package including bonus, long-term equity-based incentives, and comprehensive benefits. Current benefits offered include a 401(k)-matching program; medical, dental, vision and prescription drug benefits; flexible spending accounts; life insurance and death benefits; disability, and employee assistance program. Employees will also receive 15 days PTO and 10 days paid sick leave each year, as well as 10 paid holidays. The compensation described above is subject to change and could be higher or lower than the range described above.

CTI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, gender identity, sexual orientation, age or marital status.

CTI seeks to employ qualified individuals and to provide equal employment opportunities for all applicants and employees in recruiting, hiring, placement, training, compensation, insurance, benefits, promotion, transfer, and termination. To achieve this, we are dedicated to taking affirmative action to employ and advance in employment qualified individuals with disabilities, disabled veterans, and other eligible veterans. The objective in adopting the Affirmative Action Program is to place qualified individuals with disabilities, disabled veterans and other eligible veterans in all job classifications. This Affirmative Action Program is available for inspection by any applicant or employee by contacting the Company's EEO Coordinator, in the Human Resources office, Monday through Friday, 8am to 5pm by emailing careers@ctibiopharma.com.

CTI is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know by contacting careers@ctibiopharma.com.

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