Associate Director Clinical Trial Lead (Boston area)
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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
Minimum
Qualifications:
At least 10 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
7 years of in-depth knowledge and experience in clinical trial management
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.
Preferred
Qualifications:
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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.htmlEstimated Salary: $20 to $28 per hour based on qualifications.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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
Minimum
Qualifications:
At least 10 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
7 years of in-depth knowledge and experience in clinical trial management
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.
Preferred
Qualifications:
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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.htmlEstimated Salary: $20 to $28 per hour based on qualifications.
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