Associate Director, Clinical Trial Lead

hace 3 semanas

Madrid, España Merck KGaA A tiempo completo

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**
- Manages multiple studies, projects, and work streams with **high complexity **, risk, impact and reach, typically Ph III and registrational/pivotal studies in mixed sourcing models.
- Demonstrates skills in **successfully leading **large-sized global project teams in a matrix organization and directs, influences and motivates people; coordinates 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 plan within the 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 and objectives of the Clinical Operations Team and/or Global Program Team.
- Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical **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 business objectives and 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 expert on cross functional teams or projects.
- Ensure all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit & inspection leadership
- interviewee & responses.
- Contribute to non-study -related initiatives in addition to study assignments. Provide reports to senior management, including updates on financials, forecasts and timelines independently.
- Demonstrates creativity and innovation to support projects from a **strategic perspective **, able to predict the result of action in advance and evaluate options to achieve goals.

**Who you are**
- At least 10-12 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth knowledge and experience in clinical trial management including managerial responsibility. Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification (CPM, PMP) desirable.
- Proven 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 startup through final study report.
- Experience in multiple Therapeutic Areas (oncology and immunology preferred)
- Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Requires expert knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge.
- Strong leadership competencies and influencing skills.
- Proven team dynamic knowledge and skills and 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 functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity

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