ROLE AND RESPONSIBILITIES
This role is instrumental in supporting the growth of the pipeline in immuno-oncology and hematology-oncology. The successful candidate has hands-on responsibility designing clinical trials to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of biologic and cellular immunotherapies, managing scientific collaborations with pre-eminent academic institutions and consultants, and participating in health authority interaction activities to support CMA/BLA submissions.
- Designs and optimizes immuno-oncology and biologic therapy clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the clinical development team.
- Serves as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the clinical operations team.
- As the medical lead of a study, responsible for ensuring data quality, summary and writing of clinical study reports in close collaboration with the clinical operations, biometrics and medical writing team.
- Works on CMA and BLA submission documents.
- Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators.
- Interacts with study investigators, thought leaders, including advisory boards, academicians, and internal colleagues.
- Ensures adherence to company’s Standard Operating Procedures.
- Maintains clinical and scientific awareness in area of expertise.
Travel may be required (up to 25%).
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is an essential part of the job.
Minimum of an M.D. or Ph.D., and advanced training in hematology, oncology, with immunology or similar experience preferred. Board certification is preferred.
Minimum 2 years of industry experience designing, leading and managing clinical studies in solid tumors, hematologic malignancies and preferably immuno-oncology. Title commensurate with experience.
Must have closed a clinical study and authored a clinical study report in industry. CMA/NDA/BLA experience a plus.
Demonstrated understanding of the drug development process.
Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
Ability to effectively evaluate outside expert advice.
Ability to communicate and explain immunologic and oncologic technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
Ability to work independently.
Experience working effectively in a fast-paced, team-based environment.
Strong clinical/scientific/technical skills.
Strong interpersonal capabilities.
Ability to anticipate and resolve problems effectively.
Strong verbal communication and technical writing skills.
Ability to present clearly using scientific and clinical terminology.
Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
Sound organizational skills.
Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
Motivates team members; fosters and nurtures teamwork.
Project management skills and focus on delivery of results.
Role model for company’s Values of patients first, innovation teamwork, community and mindset