Sr. Manager, Clinical Training and Development

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Sr. Manager, Training Manager will play a pivotal role within the Clinical Operations team at Kyowa Kirin by leading the development, implementation, and continuous improvement of clinical training programs. This position is responsible for assessing training needs, identifying skill and knowledge gaps, and designing comprehensive training plans that support the onboarding and ongoing development of Clinical Operations personnel. The Sr. Manager will create and deliver innovative instructional materials and learning experiences, maintain the department’s annual training curricula, and oversee a structured new hire training program. In addition, this role will develop and track training metrics, analyze trends, and evaluate program effectiveness to ensure alignment with business goals and regulatory requirements.

Essential Functions:

•    Lead the design and execution of a comprehensive, annual training program, project related training, and ad-hoc training needs within Global Clinical Operations, in collaboration with cross-functional partners to ensure alignment with business priorities and regulatory expectations.

•    Partner with line managers and cross-functional stakeholders to assess training and development needs for new hires and existing employees, including annual and skill enhancement requirements.

•    Design and develop engaging training materials by collaborating with subject matter experts (SMEs) across departments, regions, and external partners as needed.

•    Deliver effective training using a variety of instructional methods tailored to the audience and topic, ensuring comprehension and retention among relevant stakeholders. 

•    Implement and monitor effectiveness checks, gather and analyze training metrics, and report trends and performance outcomes to line managers and senior leadership. 
•    Determine when training requires translation and manage translation processes to ensure global accessibility and compliance. 

•    Ensure all training records are accurately documented, maintained, and filed in accordance with company policies and regulatory requirements. 

•    Represent the Clinical Operations Training on strategic initiatives and relevant team meetings, contributing subject matter expertise to support broader organizational goals.

•    Create or support the development of tools and materials needed by cross-functional teams, collaborating with SMEs to ensure consistency and quality. 

•    Manage onboarding training for all new hires; manager offboarding and handovers of employees.

•    Stay informed and aligned with ongoing trends related to GCP and Clinical Operations to ensure ongoing learning and development. 

Requirements:

Education
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Instructional Design, Organizational Development Advanced degree (Master’s, PharmD, or equivalent) in a related discipline is preferred, especially with a focus on Clinical Research, Education, or Training & Development.

Certification in instructional design, adult learning, or training (e.g., ATD, CPLP, or equivalent) is a plus.

Experience
•    Minimum of eight (8) years of progressive experience in clinical research, clinical operations, quality oversight, or related roles within the pharmaceutical, biotechnology, or CRO industry.

•    Proven track record of leading learning and development initiatives within clinical development or clinical operations.

•    Demonstrated experience applying adult learning methodologies and instructional design principles in a regulated environment.

•    Experience in designing, implementing, and evaluating training programs for diverse, global audiences.

•    Strong project management skills with the ability to manage multiple priorities and timelines in a global matrixed environment.

•    Excellent interpersonal and communication skills, with the ability to collaborate effectively across functions, regions, and external partners.

•    Proficient in MS Office Suite, especially PowerPoint and/or other presentation software for training purposes.

•    Experience working with or within global teams and