Associate Director, Study Manager - Atherosclerosis and Metabolism
MSD
Summary
This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. You will demonstrate advanced leadership and technical skills as part of a global, cross-functional team and build and coach your team in project management, communication, and collaboration skills in support of clinical trials.
Job description
Job 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.
- Review and provide 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 the 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.
Requirements
- 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 such experience, OR PhD/PharmD Degree and 2+ years of such experience
- 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
- Ability to develop short and mid-range project plans
- Strong analytical skills to drive operational milestones
- 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 (Excel, PowerPoint, Word, Outlook, etc.)
- Degree in life sciences, preferred
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.