Senior Director, Clinical Trials Management

Job Duties And Responsibilities

• Directs the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within the vaccine program(s), ensuring adherence to timelines, budgets, and quality standards.
• Develops and oversees the proliferation of study documents and plans to ensure adequate controls, aligning with GCP and regulatory requirements for study conduct.
• Provides expert input into study protocols, informed consents, clinical study reports, and other clinical documents, as appropriate for assigned studies.
• Develops and oversees the set-up, maintenance, and completeness of the Trial Master File (TMF) for inspection readiness. Reviews trial data to ensure completeness and accuracy of data and reporting in collaboration with other relevant functions.
• Collaborates with cross-functional teams and vendors on quality and compliance activities, ensuring continuous improvement in study conduct, proactively identifying and mitigating risks/issues to the study to ensure successful study conduct and reporting of study data.
• Serves as the functional representative on cross-functional teams related to the assigned program, facilitating effective communication and collaboration among various departments.
• Assumes a proactive role in cross-functional initiatives, potentially leading or contributing as a subject matter expert, ensuring that clinical operations considerations are integrated effectively.
• Contributes to the development and refinement of organizational policies, procedures, and resourcing strategies related to clinical operations activities.
• Manages direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities.
• Collaborates closely with the Clinical Operations leadership team, potentially serving as a member of the team to share insights, contribute to strategic decisions, and align program-level activities with departmental goals.

Key Core Competencies

• Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP and ICH-Guidelines.
• Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.
• A thorough understanding of the drug development process.
• Experience as a clinical operations lead for global studies.
• Current on industry standards and trends.
• Familiarity and experience working with global team members and experience managing expats or those assigned to work abroad.
• Excellent written and oral communication skills to effectively communicate in English.
• Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.
• Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English.
• Ability to write reports, business correspondence and procedure manuals in English.
• Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
• Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.
• Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.
• Must have experience interfacing and managing multiple vendors/contractors.
• Must be able to manage time, multi-task and prioritize to complete deliverables on schedule.

Education And Experience

• Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field.
• Minimum 15+ years (w/o Master’s) or 10+ years (with Master’s) of relevant experience in biotech or pharmaceutical industry.
• Preferred minimum 5 years direct experience in clinical trial management of vaccine programs.

Pay

The base salary range for this role is $236,400.00 - $295,500.00 Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.