Senior Principal Scientist, Clinical Research - Immunology/Dermatology

About the role

The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing of clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.

Responsibilities

• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
• Provide clinical development support for business development assessments of external opportunities to grow the Immunology pipeline.
• Develop clinical development strategies for investigational drugs and plan clinical trials (design, operational plans, settings) based on these strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational drugs.
• Analyze and summarize clinical findings from studies to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publication.
• Participate in internal and joint internal/external research project teams relevant to the development of new compounds.
• Supervise the activities of Clinical Scientists in the execution of clinical studies.
• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
• Assist the Executive Director in ensuring appropriate corporate personnel are informed of the progress of studies of the company’s and competitors’ drugs and internal and external expert opinion on scientific questions relevant to the area of responsibility.
• Maintain a strong scientific fund of knowledge by staying abreast of scientific developments, new research methodologies, and identifying scientifically and operationally strong investigators.
• Establish collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, Pulmonary, or rare diseases to inform and assist the evaluation of the company’s investigational drugs.
• Attend appropriate scientific meetings to maintain competency and awareness of research activities in the area of responsibility.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers around the world.
• Travel on company business approximately twenty percent (20%) of the time to manage future or ongoing clinical research projects.

Qualifications

• Education: M.D., D.O., M.D./Ph.D., or D.O./Ph.D.
• Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology.
• Minimum of 3 years of clinical medicine experience.
• Minimum of 5 years of industry experience in drug development.
• Demonstrated record of scientific scholarship and achievement.
• Strong interpersonal skills and the ability to work collaboratively in a cross-functional team environment.

Required Skills

• Clinical Decision Making
• Clinical Development
• Clinical Documentation
• Clinical Judgment
• Data Analysis
• Dermatology
• Drug Development
• Immunology

Preferred Skills

• Current Employees apply HERE
• Current Contingent Workers apply HERE
• U.S. and Puerto Rico Residents Only

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days

Pay

The salary range for this role is $282,200.00 – $444,200.00. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.