Job Summary
The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late‑stage development, the Senior 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.
Key Responsibilities
- Evaluating pre‑clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
- Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline.
- Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these strategies.
- Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs.
- Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publication.
- Participating in internal and joint internal/external research project teams relevant to the development of new compounds.
- Supervising the activities of Clinical Scientists in the execution of clinical studies.
- Working closely with a cross‑functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assisting the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies, competitors' drugs, and internal and external expert opinion on scientific questions relevant to their responsibilities.
- Maintaining a strong scientific foundation by staying aware of scientific developments, researching new methodologies, identifying strong investigators, establishing collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, Pulmonary, or rare diseases, and attending scientific meetings to maintain competency.
Additional Duties
- Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitating collaborations with external researchers worldwide.
- Travelling on company business approximately 20% of the time to manage current or ongoing clinical research projects.
Qualifications
Education minimum required: 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 Development
- Clinical Documentation
- Clinical Immunology
- Clinical Judgment
- Clinical Medicine
- Clinical Research Management
- Clinical Sciences
- Clinical Studies
- Clinical Trial Development
- Data Analysis
- Drug Development
- Gastroenterology
- Ophthalmology
- Rare Diseases
- Scientific Consulting
- Strategic Planning
Location and Work Arrangement
U.S. Hybrid Work Model: Employees in office‑based positions will work a hybrid model consisting of three on‑site days per week, Monday–Thursday, with Friday designated as a remote‑working day. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions, collective‑bargaining agreements, or any role determined not compatible with remote work.
Compensation
Salary range: $282,200.00 – $444,200.00. Eligible for annual bonus and long‑term incentive, if applicable.
Benefits
Comprehensive package including medical, dental, vision, and other insurance benefits for employee and family; retirement benefits (401(k)); paid holidays and vacation; compassionate and sick days.
Equal Employment Opportunity
We are an Equal Employment Opportunity Employer and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
Legal and Location Requirements
U.S. and Puerto Rico residents only. Requires U.S. work authorization. Current visa sponsorship not available.
#J-18808-LjbffrSenior Principal Scientist, Clinical Research, Immunology - Ophthalmology in boston at Unknown Company
This position is listed as full time and able to be worked remotely.