Senior Director, TA Clinical Operations Lead

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
10858BR
Required Education
Masters Degree/MBA
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Therapeutic Area (TA) Clinical Operations Lead is responsible for leadership and overall strategic management of one or more therapeutic areas in Clinical Trial Management (CTM). The TA Operations Lead is responsible for directing clinical operations activities and decisions including quality, timelines and costs related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned TA(s). This role is responsible for line management of staff including recruitment, retention, professional development, and performance management. The TA Operations Lead is a member of the Clinical Trial Management senior leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research projects and departmental initiatives.

Responsibilities:
  • Responsible & accountable for the successful operational delivery of all studies in the TA within the Clinical Development Plan (CDP)
  • Acts as main point of contact for clinical program level discussions prior to resource assignment
  • Ensures delivery of quality operational deliverables while ensuring consistency of process and approaches across clinical study teams within the TA and facilitates streamlined processes across CTM TA leadership
  • Provides operational insight and strategic knowledge into feasibility, timeline, and cost estimates during clinical program/study development
  • Responsible for CTM resource forecasting and resource allocation for the clinical studies across assigned TA(s)
  • Responsible for analysis of Key Performance Indicators (KPI) and operational metrics and developing appropriate action plans to address issues
  • Responsible for providing input into risk management strategy for clinical study teams and ensuring execution against the risk management plan
  • Provides timely and accurate information for the therapeutic area to the TA Project Manager (TAPM)
  • Responsible for Clinical Research Organization (CRO) partnership development and delivery of outsourced services according to study milestones
  • Responsible to ensure that CTM staff (i.e., Program Ops Leads and Clinical Study Leaders) provide an appropriate and documented level of oversight to clinical sites/CRO
  • Represents TA at CRO governance meetings and acts as point of contact for Joint Oversight Committee escalation
  • Acts as a point of escalation for the CTM Program Operations Lead and develops action plans as needed
  • Interfaces 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
  • Provides oversight for activities related to internal audits and agency inspections
  • Facilitates team discussion within clinical operations to contribute to overall lessons learned exercises
  • 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 Global Development
  • Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM standard operating procedures

Requirements:
  • Masters Degree
  • Strong interpersonal & leadership skills
  • Ability to provide strategic direction and guidance to teams aligned with development plans and objectives
  • Ability to anticipate and react to new trends in a competitive landscape and therapeutic areas to guide the organizational strategy
  • Comprehensive industry perspective for operational execution
  • Strong analytical skills with a data driven approach to planning, executing, and problem solving
  • Effective communication skills to all levels of the organization
  • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
  • Accomplished influencing and negotiation skills
  • Strong financial acumen in regards to study budget management
  • Exceptional project management, cross-functional team leadership and organizational skills
  • Ability to build successful and effective teams and collaborations
  • Demonstrated vendor management experience
  • Line management experience with demonstrated mentoring and coaching skills
  • In depth knowledge of GCP and ICH
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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Requisition Number: 10858BR