Senior Director, Clinical Operations

Location
Basking Ridge, New Jersey
Posted
Jul 23, 2021
Ref
10912BR
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:

The Sr Dir Clinical Operations will manage clinical ops staff to ensure effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent Clinical Ops in a range of cross-functional groups, global functional committees and initiatives intended to enhance function and company efficiency, productivity, regionally and globally as well as on vendor governance bodies and ensure ongoing collaboration and communication with internal stakeholders. Ensure a robust communication plan including status and timing of operational deliverables are in place for all studies and programs. Will support the development of policies, procedures and training.

Ensure global and local clinical studies are executed, in adherence to GCPs, appropriate SOPs and relevant regulations FDA regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

Oversight of and interactions with CROs and external vendors to ensure studies are conducted according to timeline, budget and quality measures set forth by Study teams. Ensure robust escalation and communication plan for CROs to best support each program.
Position will require line management responsibility of Dirs., Assoc Dirs., Clinical Study Mgrs., who are primarily responsible for the clinical operational, overall delivery and tactical execution of clinical studies. Ensure strong focus on competencies supportive of project mgt; vendor mgt and stakeholder mgt. Incumbent may be expected to serve as Program level Delivery Lead on large and/or complex programs, including involving co-development (Alliance) partners.

Responsibilities:
  • Provide outstanding leadership skills based on a sound knowledge of clinical research standards and GCP
  • Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross functional departs
  • Ensure consistent and successful execution of all operational aspects of regional and global studies as appropriate, data delivery and reporting
  • Accountable for effective support of clinical activities
  • Ensure Quality Mindset across org by focusing on detailed plans to monitor conduct of studies, management of vendors and working closely w/ QA to implement ongoing learnings from regulatory inspections
  • Engage and motivate employees to execute strategy through collaboration and transparent communication
  • Member of Clin Ops leadership team and global clinical ops committee enabling cross functional and regional collaboration, delivery of regional and global objectives and implementation of process improvements.
  • Contribute to development and review of regional / global policies & procedures. Ensure compliance w/ Company and Regulatory requirements.
  • Work w/ outsourcing procurement mgt to optimize vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions
  • Provide leadership to staff and project teams for vendor evaluation, selection, management and quality-based oversight
  • Provide guidance and training to members of clinical study teams
  • Develop best practices & lessons learned mechanisms
  • Develop risk assessment & risk mgt and clinical project mgt competencies
  • Work in collaboration w/ QM and QA to develop and implement quality activities
  • Design, update and implement innovative and best-in-class procedures and SOPs related to clinical study planning & execution, in collaboration w/ relevant functions
  • Assist in implementing TMF quality standards and developing, overseeing implementation of CAPA in relation to sponsor’s audit or regulatory inspections and ensure lessons learned are developed and shared
  • Support establishing and maintaining org structure and staffing to effectively accomplish goals and objectives
  • Responsible for management and leadership including recruitment, training, mentoring, work assignments, performance evaluations and discipline of staff
  • Accountable for performance mgt, coaching, development of staff
  • Plan career development and assess training requirements of employees and contractors

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

Education/Experience:

Master’s degree in the Sciences is acceptable.

Candidates with a Bachelor’s degree in the sciences with substantial experience may be considered for this position.

10 years relevant experience is required with a MS/MPH, or 7 years with PharmD/PhD

Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, ARO or CRO. CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant


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.