Sr Dir, Therapeutic Area Operations Leader - Early Development & Clinical Experimental Sciences

The Sr. Director, Therapeutic Area (TA) Operations Leader, Early Development & Clinical Experimental Sciences (CES) is responsible for leadership and strategic management of assigned therapeutic area(s) in Clinical Trial Management (CTM). The TA Operations Leader 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 regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned TA(s). This role will handle line management of staff including recruitment, retention, professional development, and performance management. The TA Operations Leader reports to the head of CTM and 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 projects and departmental initiatives.

Job Duties:

• Partners with the Therapeutic Area Head and Global Program Head, meets regularly to review TA program status and progress

• Responsible & accountable for the operational delivery of all studies in the TA within the Clinical Development Plan (CDP)

• Acts as primary point of contact for clinical program level discussions prior to resource assignment

• Ensures delivery of quality operational results 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 program/study development; provide insights and validate operational plan

• Responsible for CTM resource forecasting and resource allocation for the clinical studies across assigned TA(s) as well as supervising resource related requirements for our key vendors supporting study management and monitoring.

• 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 plan

• Accountable for the financial stewardship of programs within the assigned TA, working in close partnership with Finance, Cost Management, and Procurement

• 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 Leaders and Clinical Study Leads) 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 Leader and develops action plans as needed

• Works with management to report on achievements 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 and drive overall inspections readiness across teams

• Facilitates team discussion within clinical operations to contribute to overall lessons learned exercises

• Proactively partners with cross-functional counterparts and external vendors to address issues and mitigate risk

• 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

• May participate in enterprise/company level initiatives to represent functional area

• Responsible for identification of innovative ways to clinical study execution including global considerations and continuous improvement of CTM standard operating procedures

• May require 25% travel

Requirements:

Bachelors Degree required. Advanced degree preferred. Minimum of 15 years relevant industry experience.

• Experience leading global clinical research activities

• Strong interpersonal & leadership skills

• Ability to provide strategic direction and guidance to teams aligned with development plans and objectives; ability to capitalize on opportunities and manage risk

• 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, implementing, 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 program & study budget management

• Outstanding 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