Director, Clinical Operations

Location
Basking Ridge, New Jersey, United States
Posted
Sep 16, 2020
Ref
10478BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

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), Food & Drug Administration (FDA) regulations/EU Directive, & International Conference on Harmonization (ICH) guidelines.
A key focus will be the oversight of & interactions with CROs & other external vendors to ensure studies are conducted according to the timeline, budget & quality measures set forth by the Study team.

The Director will take responsibility for the clinical operational strategy & overall delivery of the clinical study (i.e. Delivery Lead role) & 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 & tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies, including those involving co-development (Alliance) partners.

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 & franchise levels. May represents Clinical Operations on the Strategy & Portfolio or Clinical Sub Teams in their therapeutic area.
  • Ensure operational aspects are incorporated into CDP planning & individual protocols to facilitate successful implementation of programs.

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 & create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process & provide input into ARO selection.
  • Validate the study implementation plan provided by the CRO through to study close out & CSR writing. Ensure the timing of the major study milestones & the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).
  • Oversee the CRO & provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment & ensure mitigation & contingency measures are prepared & implemented. Actively assess potential risks to the study & propose mitigation plans.

CRO & 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 & Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.
  • Design, update & implement appropriate innovative & best-in-class procedures & SOP's related to clinical study oversight & execution.
  • Work with TMF Operations to ensure a state of inspection readiness for all TMFs & 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 & budget at an overall study level. Specifically, track major study milestones & monitor overall operational performance metrics through the life of the study.
  • Create the budget at study start up, & monitor the overall agreed budget against trial progress. Work closely with internal & external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) & budget, so both can be managed appropriately.
  • Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification & Management Log (RIM Log) & other risk related plans & ensure study team adherence & utilization.

People & 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 & contractors to ensure adequate staffing at all times.
  • This position may require the supervision of functional &/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals & career path requirements for their direct reports.


Education/Experience:
  • Qualified candidates must have a Bachelor's degree from an accredited college or university; A degree in the Sciences is acceptable.
  • 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
Clinical Development Operations

State
New Jersey