Senior Principal Scientist, Clinical Research, Thoracic Malignancies
About The Position
The Senior Director (Sr. Principal Scientist) is primarily responsible for planning and directing clinical research activities involving new or marketed Oncology medicines across all phases of clinical development, from pre-clinical development through post-licensure. The role oversees the clinical development cycle, including study design, placement, monitoring, analysis, regulatory reporting, and publication. The position evaluates pre-clinical and translational research to develop early clinical development plans and Investigational New Drug applications, creates clinical development strategies, and plans and manages clinical trials. It analyzes and summarizes study findings to support safety and efficacy decisions, regulatory applications, clinical study reports, and publications. The role also participates in internal and joint research teams and may supervise Clinical Scientists, collaborate with cross-functional experts, and assist senior leadership with communications about study progress and relevant scientific opinion. The Senior Director maintains scientific expertise by tracking developments and research methods, identifying strong investigators, building relationships with clinical investigators, and attending scientific meetings. The role may author development documents, presentations, budgets, and position papers; facilitate collaborations with external researchers; and travel for company business. The position is hybrid, based primarily in North Wales, Pennsylvania, with domestic relocation available and visa sponsorship offered.
Requirements
- M.D. or M.D./Ph.D.
- Experience in industry or as senior faculty in academia.
- At least 3 years of clinical medicine experience.
- At least 3 years of industry experience in drug development or biomedical research experience in academia.
- Demonstrated record of scientific scholarship and achievement.
- Proven track record in clinical medicine and a background in biomedical research.
- Strong interpersonal skills and ability to function in a team environment.
- Outstanding verbal and written communication and presentation skills.
- Skills in cancer research, clinical development, clinical trials, cross-functional teamwork, drug development, and Oncology trials.
Nice To Haves
- Board certified or eligible in Oncology.
- Prior specific experience in clinical research.
- Prior publication.
Responsibilities
- Plan and direct clinical research activities for new or marketed Oncology medicines across clinical development phases.
- Manage the clinical development cycle, including study design, placement, monitoring, analysis, regulatory reporting, and publication.
- Evaluate pre-clinical and translational research to develop early clinical development plans and Investigational New Drug applications.
- Develop clinical development strategies for investigational or marketed Oncology drugs.
- Plan clinical trials, including their design, operational plans, and settings.
- Monitor and manage ongoing and new clinical trials.
- Analyze and summarize clinical study findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams related to new compounds and further study of marketed compounds.
- May supervise Clinical Scientists executing clinical studies.
- Collaborate with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist the Senior/Executive Director in informing corporate personnel about study progress, competitor drug studies, and relevant internal and external scientific opinion.
- Maintain awareness of scientific developments and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators and establish communications with prominent clinical investigators.
- Attend scientific meetings to maintain competency and awareness of research activity.
- May author development documents, presentations, budgets, and position papers for internal and external audiences.
- May facilitate collaborations with external researchers around the world.
- Travel on company business to manage clinical research projects.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
