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 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 departments annual training curricula and oversee a structured new hire training 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
Bachelors degree in Life Sciences Nursing Pharmacy Instructional Design Organizational Development Advanced degree (Masters 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 adapting training content to diverse cultural and regulatory needs.

Familiarity with GCP ICH guidelines and global clinical regulatory frameworks.

Technical Skills
Digital content creation skills including proficiency with eLearning authoring tools (e.g. Articulate 360 Adobe Captivate Vyond or similar).

Working knowledge of Learning Management Systems (LMS) for training administration and tracking.

Strong critical thinking and problem-solving skills to assess training gaps and propose effective solutions.

Ability to work and communicate effectively across different regions and functions within a global multicultural environment.

Skilled in developing and using training metrics and analytics to evaluate program effectiveness and drive improvements.

High attention to detail and organizational skills with the ability to manage complex documentation and compliance requirements.

Working Conditions:

Requires up to 50% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

The anticipated salary for this position will be $15500 to $170000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site the personal data contained in your application will be collected and stored by Kyowa Kirin Inc. (Controller) which is located at 510 Carnegie Center Dr. Princeton NJ 08540 USA and can be contacted by emailing Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers recruitment related activities which include setting up and conducting interviews and tests for applicants evaluating and assessing the results thereto and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (GDPR) as necessary for the purposes of the legitimate interests pursued by the Controller which are the solicitation evaluation and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controllers behalf. Accordingly if you are located outside of the United States your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR if you are located in the European Union you have the right to request access to your personal data to request that your personal data be rectified or erased and to request that processing of your personal data be restricted. You also have the right to data portability and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data you may contact us by email at .

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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