Director, Program Lead - Immunology

About the role

This position provides oversight and leadership of clinical program execution for our Tulisokibart IBD program. In this role, you will lead and direct global, cross-functional teams in end-to-end clinical development activities.

Responsibilities

• Responsible and accountable for the operational execution of a suite of clinical trials encompassing a clinical program.
• Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; senior management, and governance meetings; regulatory agency interactions; advisory meeting preparation).
• Serves as an escalation point for issues and promotes cross-function solutions.
• Leads efforts to maximize operational feasibility and efficiency. Ensure consistency and quality across assigned portfolio.
• Serve as the operational representative on the Product Development’s Clinical Subteam.
• Contributes to resource planning and staffing (hiring and/or project onboarding, supervision of clinical scientists and study managers).
• Collaborate and facilitate interactions with key internal and external stakeholders (e.g., KOLs, supplies) in support of clinical program objectives.
• Aid the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations.
• May lead and/or implement process improvement and strategic initiatives.
• Manage direct reports including professional development and performance management.

Qualifications

• Demonstrated ability to drive and manage clinical program(s) (e.g., strategic planning through post-approval).
• Experience in conducting global clinical trials programs, including product planning through initial filing in Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune-mediated disorders (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, hidradenitis suppurative, atopic dermatitis, etc.).
• Experience with selecting and utilizing programmatic vendors, including but not limited to imaging, histopathology, electronic clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
• Experience in developing protocols and study related documents for Immunology related clinical trials.

Skills

• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US And Puerto Rico Residents Only
• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
• Please click here if you need an accommodation during the application or hiring process.
• Requirements
• As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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.
• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
• The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
• We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
• Preferred Skills
• Experience in conducting clinical trials in gastrointestinal, preferably autoimmune and/or immune mediated disease trials.
• Experience with selecting and utilizing programmatic vendors, including but not limited to imaging, histopathology, electronic clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
• Experience in developing protocols and study related documents for Immunology related clinical trials.

Benefits

• The salary range for this role is $173,200.00 - $272,600.00
• 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.
• We offer a comprehensive package of benefits. Available benefits include 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.