Senior Director, Group Lead Clinical Trial Mgt (Hematology/Oncology)

Tarrytown, NY, United States
Dec 22, 2020
Required Education
Bachelors Degree
Position Type
Full time
The Senior Director, Group Lead CTM, Hematology/Oncology leads and manage operational delivery of a portfolio of programs across and within Oncology in Clinical Trial Management (CTM). The Group Lead directs clinical operations activities and decisions including quality, timelines and costs of clinical research studies in accordance with ICH/GCP regulations and company Standard Operating Procedures (SOPs) across assigned oncology programs.
This role coordinates line management of staff including recruitment, retention, professional development, and performance management. He/She is a member of the CTM leadership team, and interacts with senior level management, external vendors, collaboration partners and clinical study personnel for assigned projects and departmental initiatives.
  • Responsible for the successful operation of all studies across Portfolio of studies/programs within the Clinical Development Plan (CDP) for Oncology.
  • Acts as the main point of contact for clinical program level discussions prior to resource assignment.
  • Provides operational insight and strategic knowledge into feasibility, timeline, and cost estimates during clinical program/study development.
  • Accountable for CTM resource forecasting and prioritization for the clinical studies across assigned programs.
  • Leads maintenance and analysis of Key Performance Indicators and operational metrics, and develops appropriate action plans to address issues.
  • Contributes input into risk management strategy for clinical study teams and ensuring execution against the risk management plan.
  • Assess and communicates operational trends and areas for improvements to TA Operational Leader.
  • Provides innovative and flexible operational solutions to cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges.
  • Responsible for Clinical Research Organization (CRO) partnership development and delivery of outsourced services.
  • Responsible to ensure that CTM staff (i.e., Program Ops Leads, Clinical Study Leaders) provide an appropriate and documented level of oversight to clinical sites/CRO.
  • Represents at CRO governance meetings and acts as point of contact for Joint Oversight Committee critical issue.
  • Overall responsibility to manage portfolio/development/budget.
  • Acts as a point of escalation for the CTM Program Operations Lead and develops action plans as needed.
  • Leads all aspects of Joint Meetings with Collaborative Partners at the study level and program level.
  • Works with management to report on milestones including Clinical Operations Review meetings.
  • Attends and represents CTM at internal and external meetings, including but not limited to program review committee meetings, as appropriate.
  • Drives the strategy and oversight for vendor selection and management within assigned clinical program(s).
  • Ensures inspection readiness throughout the clinical program lifecycle and is the cross functional leader for Regulatory Authority Inspections.
  • Direct line management responsibilities of all CTM staff within the assigned TA include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
  • Initiates and participates in strategic projects and initiatives within the Global Development organization.
  • Responsible for identifying innovative ways to clinical study execution including global considerations and continuous improvement of CTM operating procedures.
  • Advanced degree preferred and minimum of 15+ years relevant industry experience
  • Proven clinical operations expertise in solid oncology; experience with hematology & oncology highly preferred
  • Ability to manage and influence diverse partners
  • Ability to provide strategic direction and mentorship to teams aligned with development plans and objectives
  • Strong analytical skills with a data driven approach to planning, executing, and problem solving
  • Ability to anticipate and react to new trends in a competitive landscape and therapeutic areas to guide the organizational strategy
  • Effective communication skills to all levels of the organization
  • Proactive and self-disciplined. Outstanding project management, cross-functional team leadership and organizational skills
  • Strong financial acumen regarding study budget management
  • Demonstrated vendor management experience
  • In depth knowledge of GCP and ICH
  • May require up to 25% travel
Key Team Membership:
  • CTM Leadership Team
  • Vendor Governance Committee(s)
  • Clinical Operations Review Meeting(s)
  • Development Team(s)
  • Clinical Compliance Meeting(s)
  • Strategy Review Meeting(s)
Cross Functional Interfaces
  • Key clinical and regulatory functional area leads
  • Project Management
  • Medical Director(s)
  • Procurement
  • Clinical Finance

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.