About the Company
Our client, a global pharmaceutical leader committed to strive toward better health for people worldwide through leading innovation in medicine, is currently seeking a Senior Director of Clinical Operations to join their CNS team. This is chance to be a vital contributor in a highly-visible role, overseeing a robust portfolio of clinical programs and their clinical studies.
The Senior Director of Clinical Operations, specializing in Central Nervous System (CNS) therapeutic area, will be responsible for collaborating with Regional Heads of Development Operations to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Key responsibilities include:
- The on-time, on-budget delivery of clinical trials in support of IGDP and studies.
- Ensuring clinical operations process and work products are compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Overseeing the development of clinical operations strategy, execution and management for TDC global clinical programs in assigned therapeutic area or disease pathway or therapeutic area(s) or disease pathway(s), supporting clinical strategy defined in the Clinical Development Plan (CDP)
- Representing Global Clinical Operations at therapeutic area or disease pathway level as primary point of contact for therapeutic area or disease pathway Heads, internal stakeholders and Strategic Partners and vendors
- Functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) in a matrix environment.
- Leading the development of consistent Clinical Operations processes and creating the support for unified approaches across CNS
- Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling
- Supporting Global Development Strategic Outsourcing by leading portfolio level planning and Early Engagement process with strategic vendors in assigned therapeutic area or therapeutic areas, making recommendations for program/study allocation with strategic vendors, and participation in strategic vendor governance, including identification and resolution of performance issues.
- Bachelor’s Degree or international equivalent required, Life Sciences preferred advanced degree highly desirable.
- 12+ years clinical study/program management experience in the pharmaceutical industry, including at least 6 years of line management experience. Experience in more than one therapeutic area and a proven track record of leadership and project management success at the director level required
- Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).
- Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).
- Requires approximately 10-20 % travel, including overnight and international travel to other company sites, strategic partners and therapeutic area required travel.
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