Associate Director, Study Manager - Atherosclerosis and Metabolism

About the role

This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. You will have the opportunity to demonstrate advanced leadership and technical skills as part of a global, cross-functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of clinical trials.

Responsibilities

• Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s).
• Serves as the Clinical Trial Team (CTT) lead.
• Leads and directs teams in key study planning, development, and execution elements (e.g., operational reviews, issue escalation/mitigations, presentations at Sr. Management meetings, program level cross functional meetings and governance).
• Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.
• Liaises with partners, vendors, and vendor management team.
• Reviews and provides clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.
• May serve as a subject matter expert and/or participate on process improvement teams.
• Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.
• May include management of direct/indirect reports including assignment of resources, professional development, and performance management.

Core Skills

• Strong knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH)).
• Proven ability to manage competing priorities and effectively delegate and assign activities to meet business needs.
• Ability to develop short and mid-range project plans that are realistic and effective at meeting goals.
• Strong analytical skills to drive operational milestones.
• 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 a proactive approach, strategic thinking and leadership driving toward study goals.
• Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment.
• Problem solving, prioritization, conflict resolution, and critical thinking skills.
• Strong communication, writing, and presentation skills.
• Proficient knowledge in Microsoft Office or similar (Excel, PowerPoint, Word, Outlook, etc.).

Education/Experience

• Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• OR Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• OR PhD/PharmD Degree and 2+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Degree in life sciences preferred

Required Skills

• Adaptability
• Analytical Problem Solving
• Clinical Data Management
• Clinical Study Management
• Collaboration
• Detail-Oriented
• Ethical Standards
• Good Clinical Practice (GCP)
• Stakeholder Alignment
• Strategic Thinking

Preferred Skills

• Process Improvements
• Program Management
• Project Management

Pay

The salary range for this role is $142,400.00 – $224,100.00. 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.

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