Associate Director, Project Management
Merck
Summary
The Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group supports the technical, operational, and scientific aspects of drug development in NDS. This role partners with Discovery Program Leaders, Compound Leaders, and Therapeutic Area Leaders, working cross-functionally in a highly matrixed organization to ensure efficient coordination of nonclinical safety data to support discovery and development programs within the Research & Development Division.
Job description
Primary Responsibilities
- Ensure scientifically rigorous study designs are developed, requested, and communicated within NDS and associated study scheduling systems.
- Interface with Operations–Project Planning (NDS) and impacted laboratory/operational areas on changes in study designs or timelines.
- Coordinate collaboration and interactions with Central Pharmacy (NDS) and other areas in Discovery, Preclinical, and Translational Medicine (DPTM) for drug supply, allocation of materials, formulation, and stability matters.
- Coordinate with NDS and program team stakeholders to manage and align study and submission timelines, ensuring NDS deliverables are completed in accordance with program objectives.
- Assist with the development of regulatory packages, including PSURs/DSURs, IBs, IND/IMPDs, and WMAs.
- Track regulatory agency comments and resolutions.
- Highlight program issues and ensure they are appropriately escalated to NDS management.
- Standardize and streamline drug development procedures within NDS and across DPTM.
- Train and support new Discovery Program Leaders (DPLs) and Compound Leaders (CLs) in components of drug discovery and development.
- Lead independent projects/assignments related to nonclinical drug discovery and development.
- Integrate AI/ML tools, including generative AI, to streamline program support activities, synthesize nonclinical data, mine insights, generate hypotheses, and inform project decisions.
Minimum Education
BA/BS or equivalent in biological sciences, chemical or pharmaceutical/medical/regulatory sciences required. Preferred: MA/MS/MBA in related science or business discipline, or a project management certification (e.g., Project Management Professional [PMP]).
Required Experience and Skills
- At least 5 years of experience in NDS or similar functions.
- Proven knowledge of drug discovery and development processes and guidelines, particularly nonclinical strategies.
- Familiarity with the range of nonclinical studies required to support drug discovery, clinical development, and marketing approval.
- Demonstrated cross-functional collaboration skills and the ability to succeed in a matrixed environment.
- Excellent communication skills, including experience facilitating meetings, presenting, and managing team interactions.
- Ability to execute independent projects and balance activities for multiple projects simultaneously.
- Ability to take on urgent assignments independently, reprioritize other work, and coordinate with other areas as needed.
Required Skills
Drug Development, Drug Discovery Research, Matrix Management, Multidisciplinary Teamwork, Project Management, Project Planning, Strategic Planning, Study Design
Requirements
- BA/BS or equivalent in biological sciences, chemical or pharmaceutical/medical/regulatory sciences
- At least 5 years of experience in NDS or similar functions
- Proven knowledge of drug discovery and development processes and guidelines, particularly nonclinical strategies
- Familiarity with the range of nonclinical studies required to support drug discovery, clinical development, and marketing approval
- Demonstrated cross-functional collaboration skills and ability to succeed in a matrixed environment
- Excellent communication skills, including facilitating meetings, presenting, and managing team interactions
- Ability to execute independent projects and balance activities for multiple projects simultaneously
- Ability to take on urgent assignments independently, reprioritize other work, and coordinate with other areas as needed
- Drug Development
- Drug Discovery Research
- Matrix Management
- Multidisciplinary Teamwork
- Project Management
- Project Planning
- Strategic Planning
- Study Design
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.