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Director, Clinical Operational Excellence

Brisbane, CA, USA | Myovant Sciences Ltd.

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    15-20 years
Job Description:
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The Director, Clinical Operational Excellence oversees clinical operation processes and systems, training programs, and implementing appropriate standard processes and operating procedures (SOPs) to ensure GCP compliance and inspection readiness within Clinical Operations. The Director may also sponsor and/or lead key strategic Clinical Operations organizational initiatives. 


Essential Duties and Responsibilities


Leads the creation, deployment, and management of Clinical Operations’ systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities

Oversees the development and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP guidelines and company policies to ensure inspection readiness

Represents Clinical Operations on Inspection Readiness progress and activities

Partners with Clinical Quality Assurance to oversee GCP regulatory authority inspections on behalf of Clinical Operations

Provides oversight and strategic guidance for key clinical systems, such as eTMF and document management

Actively participates as a member of the Clinical Operations Leadership Team in the development and execution of organizational initiatives, goals, and strategies

Leads key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments.Includes the identification of process challenges, process enhancements, and training

Accountable for the management of any additional future Clinical Systems, Solutions, and Compliance staff or consultants

Provides input to and rationale for department budget and maintaining control of functional expenditures against department budget as they relate to this role

May develop and present strategic and operational plans to senior management



Core Competencies, Knowledge, and Skill Requirements


Strong working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines

Experience in preparing teams for GCP inspection readiness as part of NDA/MAA activities, including creation and organization of eTMF and document management

Strong sub-team leadership skills with managerial experience

Proven experience handling confidential and/or sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required

Creative, flexible thinker with strong strategic planning and decision-making skills

Ability to deal effectively with time demands, incomplete information or unexpected events

Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction

Continuously demonstrates a positive, ‘can-do’ and service-oriented attitude.Strong oral and written communicator; detail-oriented with a commitment to accuracy

Must have the ability to build and maintain positive relationships with senior management, peers, and other colleagues

Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks

Ability to manage multiple responsibilities and shift priorities quickly while working under tight deadlines

Skilled in developing collaborative internal and external relationships

Required skill in the operation of standard office equipment including: computers (common software programs), copy machines, and other equipment as necessary

Excellent verbal and written communication skills, as the position will interface with employees, vendors, and other external people.

Ability to ensure optimal relationships with key internal stakeholders, as well as vendors, to enable the successful development and deployment of Clinical Operations and cross-functional Development processes, clinical systems, quality documentation and training programs, as appropriate

Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.



REQUIREMENTS


Education

Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline required


Experience


At least 15 years of experience in Clinical Research, with a focus on biotech and/or pharmaceutical Clinical Operations

The ideal candidate will have demonstrated ability in the following additional areas: GCP regulatory authority inspections, process development and improvement, training and development, development of a clinical compliance function, and clinical systems, and managing people

Experience developing and leading a clinical risk management function and the ability to demonstrate an understanding of a clinical quality management system

Previous experience in leading a function or business unit, including the management of related budgets, timelines, and resources

Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections

Previous experience focusing on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors

Experience working in a fast-paced, dynamic corporate environment

Previous experience leading key strategic functional initiatives


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