Director, Clinical Trial Lead (all genders)

Your Role: You will manage multiple studies, projects, and work streams with very high complexity, risk, impact and reach, typically Phase III and registrational/pivotal studies in a hybrid-sourcing or in-house model. You will lead large-sized global project teams in a matrix organization, directing, influencing and motivating stakeholders from closely related areas and beyond, creating a positive working climate. You will develop the clinical trial strategy while being accountable for successful project execution and delivery of the clinical operational budget, timelines and quality standards agreed upon by Governance Committees. You will be a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligning the trial team with organizational goals, the Clinical Operations Team, and the Global Program Strategy Team.

You will filter, prioritize, analyze and validate 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. You will demonstrate Subject Matter Expert level understanding of multiple functions and functional processes, while being familiar with and considering the overall company strategy. You will act as a senior advisor and mentor within the team and beyond, serving as a best-practice resource within your discipline or across technical functional teams or projects. You will ensure all study management activities are completed in accordance with SOPs/WIs and local regulatory guidance including ICH-GCP, including audit leadership and interview responses. You will contribute to non-study-related initiatives in addition to study assignments and provide reports to senior management, including updates and timelines, independently. You will demonstrate a high level of creativity and innovation to support projects from a strategic perspective, able to predict outcomes and drive toward goal achievement.

Who you are:

• Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification desirable.
• At least 12 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 10 years of in-depth knowledge and experience in clinical trial management including managerial responsibility.
• Expert experience in multiple Therapeutic Areas.
• Requires extensive professional experience in relevant disciplines and substantial project management experience, with strong market and competitor knowledge.
• Expert experience in all aspects of clinical study planning and startup (including budget and resource planning), and in executing the complete range of clinical study activities from start up through final study report.
• Strong leadership competencies and influencing skills.
• Effective oral and written communication skills.
• Proven ability to foster partnerships across projects and multidisciplinary teams.