Clinical Operations Project Lead

SanofiCambridge, MA
$206,250 - $297,917Hybrid

About The Position

The Clinical Operations Project Lead (COPL) provides strategic input into the global development plan as well as directs, supervises and manages all operational aspects of global clinical projects and is accountable for ensuring quality deliverables on time and within budget. The COPL is a core member of the Global Project Team (GPT) and co-manages the Clinical Sub-Team (CST). The COPL is expected to be able to effectively lead large, complicated program development and/or multiple programs simultaneously with minimal guidance. The COPL is the main partner between the global project team and the larger operations group and manages project deliverables on a day-to-day basis. The COPL is accountable for ensuring deliverables through effective program/project management, using his/her business acumen and people skills to optimize CSO resources and lead studies in an effective and agile manner. The COPL is also the CSO’s main interface with other functions and units for the project and enabling functions. The COPL is expected to teach, coach and mentor direct reports and contributes to process improvement efforts and drives operational process implementation and compliance, while taking clear action to foster innovation along the value chain. The COPL may lead and manage a team of several Clinical Operations Study Leads (COSL) in their project (anywhere from 4 to 8).

Requirements

  • Strong project management experience, transversal and strategic leadership capabilities, communication skills and a business acumen are required.
  • Ability to drive for a high performance cross-functional team that empowers and motivates individual members and the team as a whole.
  • Strong interpersonal skills required to effectively collaborate with internal and external stakeholders (physicians, scientists, project heads and managers from various disciplines) and to set and manage expectations clearly.
  • Proactively ensures targets and milestones are met; capitalizes on opportunities to exceed expectations.
  • Serves as internal consultant and primary liaison with all groups outside of the CSO for projects.
  • Outstanding and proven project management skills
  • Strong capability to effectively handle large complicated global projects that integrate various disciplines.
  • Business acumen – very strong understanding of the business strategy and business processes
  • Excellent organizational, interpersonal and communication skills (verbal & written)
  • Innovative mindset and ability to introduce new ways of working and/or digital tools
  • Customer and quality focused
  • Ability to drive decision-making process and take thoughtful risks in decision-making
  • Innovative problem-solving
  • Proven change management skills
  • Strong people/management skills
  • Ability to effectively coach and mentor others
  • Strong presentation skills at C-Suite level with an ability to influence as well as deliver clear and concise messages.
  • Results driven, self-starter who Takes Action
  • Detail-oriented and good organizational skills.
  • Ability to manage conflict effectively and to navigate organizational politics/team dynamics.
  • Strong negotiation skills
  • Able to communicate well understanding different cultures, values, and styles.
  • Bachelor's degree in Life Sciences, Biomedical Sciences, or related field with 15+ years of laboratory, medical, or pharmaceutical research experience in a pharmaceutical industry setting, including at least 10 years managing projects or international clinical studies.

Nice To Haves

  • Advanced degree preferred

Responsibilities

  • Responsible for providing input into the operational strategy, prepares operational assumptions at project level to support development of global study budgets, and accountable for development of operational plans, with input from all applicable functions within the CSO, in order to propose the optimal clinical operations solutions and scopes of work that creates the most value for the project and company.
  • Accountable for ensuring the study/program performance within the CSO and for driving the multi-disciplinary CSO project team according to project requirements & defined project objectives to create the most value for the project.
  • Accountable for COSL resources planning and drive/coach the COSL for study execution.
  • Represents CSO when collaborating and goal setting with other functions and across projects, enabling functions to successfully meet the requirements, milestones, and deliverables of the clinical development plan as defined by the GPT.
  • Contribute to CSO business expansion and innovation, including use of digital tools/AI to accelerate the portfolio.
  • Identify opportunities for improving organizational processes to continue to drive organizational and operational excellence.
  • Ensure performance and development cycle is completed for all direct reports (COSL): set priorities, identify people skills, needs, support his/her sub-group to develop Individual Development plan, and provide regular performance feedback.
  • Mentoring: including other COPL, COSL, and other indirect reports

Benefits

  • high-quality healthcare
  • prevention and wellness programs
  • at least 14 weeks’ gender-neutral parental leave
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