Senior Director, Clinical Operations - Florham Park, United States - Shionogi

Description

Overview

The Senior Director, Clinical Operations holds accountability for developing strategic objectives and overseeing the tactical implementation of global or regional clinical programs for the rare disease franchise, aiming to deliver high-quality products and ensure business success for Shionogi in the marketplace.

This pivotal role involves providing input to the leadership team on global strategies and functional initiatives with financial implications for organizational performance.

Additionally, the Senior Director directly manages teams and provides oversight and mentoring to project team members. Responsibilities encompass aligning clinical programs with organizational goals and regulatory requirements, fostering cross-functional collaboration, managing risks, engaging stakeholders....

Responsibilities

The Senior Director, Clinical Operations holds accountability for developing strategic objectives and overseeing the tactical implementation of global or regional clinical programs for the rare disease franchise, aiming to deliver high-quality products and ensure business success for Shionogi in the marketplace.

This pivotal role involves providing input to the leadership team on global strategies and functional initiatives with financial implications for organizational performance.

Additionally, the Senior Director directly manages teams and provides oversight and mentoring to project team members.

Responsibilities encompass aligning clinical programs with organizational goals and regulatory requirements, fostering cross-functional collaboration, managing risks, engaging stakeholders, driving global alignment and excellence, and ensuring compliance and quality assurance across clinical programs.

Through effective leadership and strategic direction, the Senior Director plays a critical role in driving success and achieving Shionogi's objectives in the clinical operations domain.

RESPONSIBILITIES

• Provide strategic direction for global or regional clinical programs, ensuring alignment with organizational goals and regulatory requirements. Collaborate with leadership to develop and execute plans with financial implications for organizational success.
• At the project/study level, identifies and develops necessary internal and external inputs to ensure that protocol designs align with scientific and regulatory standards. Engages relevant external stakeholders, such as patient advocacy groups, to ensure patient-centricity in adherence to guidelines.
• Foster alignment with cross-functional teams to support project strategic plans, regulatory requirements, and commercial goals. Anticipate market factors that could influence strategies and the company's position.
• Collaborate with Risk Management to identify and mitigate program/study risks. Implement and monitor mitigation plans across studies to ensure compliance and minimize impact on timelines and quality.
• Lead the identification, selection, and management of CROs and other vendors. Serve as the operational interface with external partners to address issues and ensure timely and cost-effective implementation of clinical programs/studies.
• Establish and maintain effective communication with internal stakeholders and external partners. Cultivate relationships with key counterparts in functions such as Research, Regulatory, Data Management, and Commercial. Externally, interact with a diverse range of scientific external experts (e.g. regulators, CROs/vendors, consultants, investigators and industry partnerships)
• Drive alignment, integration, and excellence in clinical management activities on a global scale. Implement innovative procedures and establish global standards to enhance clinical trial execution.
• Other duties as assigned.

MINIMUM JOB REQUIREMENTS
Qualifications

• Bachelor's degree in a relevant field such as life sciences, pharmacy, nursing, or business administration. Advanced degrees preferred. Project management certification is desirable.
• Minimum of 12 years of progressively responsible experience in clinical operations within the pharmaceutical or biotechnology industry, with a proven track record of leadership in overseeing global or regional clinical programs.
• Extensive experience in clinical operations within the pharmaceutical or biotechnology industry, including a track record of successful leadership in developing and implementing strategic objectives for global or regional clinical programs.
• Demonstrated leadership capabilities with experience in directly managing teams and providing oversight and mentoring to project team members.
• Strong understanding of regulatory requirements and industry best practices in clinical trial execution, with the ability to ensure alignment with organizational goals and regulatory standards.
• Excellent communication, negotiation, and relationship-building skills, with the ability to effectively collaborate with cross-functional teams, internal stakeholders, and external partners.
• Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable.
• Proven ability to identify and mitigate program/study risks, implement risk mitigation plans, and monitor their effectiveness to ensure compliance and minimize impacts on timelines and quality.
• Experience in identifying, selecting, and managing CROs and other vendors, with a focus on ensuring timely and cost-effective implementation of clinical programs/studies.
• Ability to drive alignment, integration, and excellence in clinical management activities on a global scale, implementing innovative procedures and establishing global standards to enhance clinical trial execution.
• Experience in maintaining compliance with regulatory standards and ensuring inspection readiness across clinical programs, including reviewing contracts, budgets, and financial reports to identify trends and issues and implementing corrective actions as needed.
• Flexibility to handle various responsibilities and adapt to changing priorities in a dynamic and fast-paced environment.

Competencies

• Ability to provide strategic direction and inspire teams to achieve organizational goals.
• Excellent verbal and written communication skills to effectively convey ideas and information to diverse stakeholders.
• Capacity to develop long-term plans and align them with organizational objectives.
• Strong collaborative skills to work effectively with cross-functional teams and external partners.
• Aptitude to identify issues, analyze root causes, and develop effective solutions.
• Deep understanding of regulatory requirements and ability to ensure compliance across clinical programs.
• Skill in identifying, assessing, and mitigating risks to minimize impact on timelines and quality.
• Proficiency in selecting and managing vendors to ensure cost-effective and timely implementation of clinical programs.
• Ability to understand and navigate global regulatory landscapes and cultural nuances in clinical operations.
• Commitment to maintaining high-quality standards and ensuring inspection readiness across clinical programs.
• Flexibility to adapt to changing priorities and navigate complex challenges in a dynamic environment.

Other Requirements

• This position has significant managerial and decision-making authority.
• Ability and willingness to travel approximately 10% of the year both domestically and internationally
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

ESSENTIAL PHYSICAL REQUIREMENTS

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18" away from face for extended period of time - up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time - up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.


DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee.

Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

EEO
Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without

regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active-Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc.

to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.