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EMD Serono, Inc. · 2 weeks ago

Associate Director, Clinical Trial Lead (on-site Billerica MA)

Billerica, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$131K/yr - $196K/yr

10+ years exp

EMD Serono, Inc. is a global company focused on innovating with science and technology to enrich lives in Healthcare, Life Science, and Electronics. The Associate Director, Clinical Trial Lead will manage complex clinical studies and lead global project teams, ensuring successful execution of clinical trial strategies and adherence to quality standards.

BiotechnologyHealth CareHealth Diagnostics

Work & Life Balance

No H1B

Responsibilities

Manages multiple studies, projects, and work streams with high complexity, risk, impact and reach, typically Ph III and registrational/sourcing models

Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences and motivate stakeholders from closely related areas and beyond, creating a positive working climate

Leads the development of the clinical trial strategy while accountable for successful project execution and delivery of clinical operational budget, timelines and quality standards agreed upon by Governance Committees

As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team

Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to operational and organizational challenges in a holistic manner to mitigate risks

Exhibits Subject Matter Expert level understanding of multiple functions and functional processes. Familiar with and considers overall company strategy

Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical functional teams or projects

Ensure all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses

Contribute to non-study -related initiatives in addition to study assignments. Provide reports to senior management, including updates and timelines independently

Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and achieve goals

Qualification

Clinical trial managementOncology experienceProject managementRegulatory knowledgeBudget planningTeam dynamicsInnovationLeadership skillsCreativity

Required

At least 10 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment

At least 7 years of in-depth experience in clinical trial management including managerial responsibility

Proven experience in all aspects of clinical study planning and startup (including budget and resource planning)

Experience in executing study activities, from startup through final study report

Requires substantial to extensive professional experience in relevant disciplines

Substantial project management experience

Strong leadership competencies and influencing skills

Proven team dynamic knowledge and skills

Ability to foster partnerships across projects and multidisciplinary teams

Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other nonclinical & pharmaceutical development, regulatory, commercial/marketing