Director, Clinical Operations

Location
Basking Ridge, New Jersey, United States
Posted
Oct 22, 2020
Ref
10527BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
~~Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

Lead execution of global or local clinical studies, programs or franchises in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines.

A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team.

The Director will take responsibility for the clinical operational strategy and overall delivery of the clinical study (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require line management responsibility of Clinical Study Managers, who are primarily responsibility for the tactical execution of the study. In the absence of Clinical Study Manager, the Director will be expected to take both strategic and tactical roles in order to deliver the study.

Responsibilities:

Operational Strategy
• Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area.

Clinical Operations
• Ensure high quality delivery of all studies for which they are responsible. This includes individual studies as well as programs or franchises.
• When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.
• Validate the study implementation plan provided by the CRO through to study close out and CSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).
• Lead site selection and site qualification discussions, kick-off meetings and study team meetings.
• Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.

CRO and Quality Oversight
• Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.
• Design, update and implement appropriate innovative and best-in-class procedures and SOP's related to clinical study oversight and execution.
• Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.
• When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.
• Create the budget at study start up and monitor the overall agreed budget against trial progress.

People and Resource Management
• Responsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times.
• This position may require the supervision of functional and/or direct reports.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• Qualified candidates must have a Bachelor's degree from an accredited college or university
• 10 years relevant experience is required with a BS, 5 years with a MS/MPH, or 5 years with PharmD/PhD

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Job Title
Director, Clinical Operations

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey