Core 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; sr. 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.
Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations.
May lead and/or implement process improvement and strategic initiatives.
Management of direct reports including professional development and performance management.
Core Skills
Demonstrated ability to drive and manage clinical program(s) (e.g., strategic planning through post-approval).
This includes the ability to:
- Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
- Interact with key stakeholders across department, division, and company. Role requires proactive approach, strategic thinking, and leadership to envision, plan and execute organizational goals
- Makes decisions guided by profit plan or budget that impact support, resourcing and implementation of projects, programs and/or technologies. Demonstrated ability to effectively delegate work to meet the business needs
- Resolves complex technical, operational, and financial problems. Decisions guided by resource availability and department objectives. Ability to take a broader view of issues to maximize benefit and/or impact to the organization
- Has strong understanding of end-to-end clinical research process
- Excellent writing and communication skills
- Demonstrated leadership skills in supervising people, managing programs & processes, leading meetings and/or influencing peers and direct reports in a matrix environment
- Problem solving, conflict resolution, and critical thinking skills
- Expert knowledge of GCP and ICH regulations
- Demonstrated project management, and time management/organizational skills
- Build team capabilities through proactive coaching
- Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements
- Strong communication skills with advanced oral and written English skills
- Advanced computer/database skills
Experience
- Bachelor’s degree + 12 years -OR- Master’s + 9 years -OR- PhD/PharmD + 6 years Pharmaceutical and/or clinical drug development experience. Degree in life sciences, preferred.
Ideal candidate would have:
- Highly preferred: 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.)
- Managing direct reports
Candidates with the with the following experiences/expertise are highly preferred, but not required:
- 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
Required Skills:
- Clinical Leadership, Clinical Programs, Clinical Strategy, Clinical Trials Operations, Coaching, Cross-Functional Leadership, Good Clinical Practice (GCP), Immunology, People Management, Program Management, Project Management, Scientific Leadership, Stakeholder Communications, Vendor Oversight
Preferred Skills:
