CTI Clinical Trial and Consulting Services
Director, Clinical Operations
CTI Clinical Trial and Consulting Services, Cambridge, Massachusetts, us, 02140
The Director, Clinical Operations Study Management is an operational and drug development subject matter expert accountable for the delivery of trials within his/her assigned portfolio of clinical trials. He/she will partner with other Clinical Operations and Expertise Area (EA) leaders. He/she must be able to collaborate, influence and lead discussions with key leaders/stakeholders to determine program priorities and will define and implement resourcing and execution strategies. He/she will provide strategic and operations leadership across clinical projects and contribute to defining the overall program strategy. He/she may also provide strategic program direction and oversight of clinical research activities, including clinical development plans, study design, protocol development, study and operational feasibility and risk assessment, key CRO and vendor relationships, KOL relationships, throughout all phases of clinical development.
The Director, Clinical Operations Study Management is an effective team leader. He/she is responsible for talent development, provides line management, supervision, coaching and mentoring of team members in his/her group. He/she is responsible for building Clinical Operations, therapeutic area, and technical skills within his/her group to ensure patient safety, quality clinical trial execution and effective delivery of trials. He/she is also a member of the Clinical Operations Leadership Team (COLT) and, as such, supports and influences the direction of the Clinical Operations group.
The Director, Clinical Operations Study Management is accountable for the delivery of clinical trials within his/her assigned portfolio and for ensuring appropriate management of study vendors/CROs. He/she will collaborate with internal stakeholders on the oversight of vendors/CROs. He/she will assist in resolving and/or escalating issues as needed. He/she is responsible to ensure the assigned clinical trials are adequately resourced, sets priorities, and manages operational plans and budgets.
The Director, Clinical Operations Study Management serves as an expert in clinical operations processes and is responsible for developing and sharing best practices within his/her team and across the Clinical Operations group. He/she will work with other Clinical Operations and Expertise Area leaders to formulate strategies, standards, processes and best practices to be implemented for the benefit across Clinical Operations.
The Director, Clinical Operations Study Management ensures strong interaction with local country, medical affairs teams/regional medical groups, and other strategic partners (e.g. site networks, patient groups) as needed for the successful delivery of clinical trials.
Summary Of Key Responsibilities
Partners directly with and/or guides internal team members along with the CRO team(s) to collaborate with preclinical, regulatory affairs, medical monitoring, biometrics, medical affairs, pharmacovigilance, and/or medical writing to develop drug development strategies, protocol and study designs, and other key study and program deliverables. Has overall accountability for the development of the Clinical Operations study/project strategy and operationalization for assigned projects.Communicates program strategy, goals, and priorities across a wide range of stakeholders ensuring that each is understood and supported.Active participation as a member of the Clinical Operations Leadership Team in driving strategy and team execution.Participates in development and review of key clinical documents such as protocol, IB, ICF, Regulatory submission documents, CRF, CSR, abstract and publication, and provides direction to team members to manage the content and process, as necessary.Effectively discusses and presents study data across the Company and with development partners; collaborates with clinical development and scientists, medical writers, and investigators to write, present and/or publish data.Maintains appropriate therapeutic area technical and working knowledge of scientific and clinical operations developments.Responsible for the guidance of clinical team members, including hiring, performance management, and ongoing coaching.Develops and implements strategies to maximize study management competency and skills related to Clinical Operations trial delivery.Responsible for shaping the Clinical Operations team culture including the retention and engagement of team members.Leads teams towards departmental and project productivity and quality metrics and provides financial and management accountability; works with study team and CRO partners to ensure appropriate Change Notification/ Change Order oversight to maintain cost control.Manages the recruitment and performance of team members to support and guide them to improved strategic drug development operational efficiency, effectiveness at prioritization, and problem identification and solving.Acts as point of contact for leadership including resolution and/or escalation of issues as appropriate.Participates in, reviews, and provides direction on development of Clinical Operations plans, CRO and vendor outsourcing strategy, and key performance indicators (KPIs) with CRO.Oversees the development of tracking tools and guides team members on effective management of project teams, project budgets, study timelines, and deliverables.Guides teams and identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action.Accountable to deliver excellence in Clinical Operations Study Management for a portfolio of clinical trials, ensuring the trials progress in accordance with agreed plans.Builds relationships with key clinical trial sites/networks.Collaborates with vendor/CRO partners and internal groups in the development of and compliance with robust inspection readiness plans to ensure high quality clinical trial conduct and data integrity.Partners with Quality Assurance and Clinical Operations Oversight teams to ensure team and vendor/CRO partners consistently deliver data which supports regulatory requirements.Key Skills
Must be self-motivated and able to work independently and successfully.Must be able to successfully manage remotely based team members as needed and as part of an international development team reporting into our US-based headquarters.Able to prioritize effectively, lead and influence, with good problem-solving and planning abilities to enable teams to succeed in study start, execution and completion in a timely fashion. Must possess strong organizational skills and ability to deal with competing priorities.Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs) and ICH Guidelines.Willingness to travel internationally as required.Superb communication skills (written, verbal and presentation).Ideally a combined mix of large company best practices and small company adaptability and experience.Willingness and proven ability to work flexibly, stepping outside of immediate role responsibilities and wear ‘multiple-hats’ where needed.Confident and has the professional competence to win respect and gain credibility at all levels within and outside the Company, and capable of successfully representing the Company externally.Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.Scientific Understanding: Thorough comprehension of therapeutic mechanisms of focus and current scientific developments within his/her area of expertise to provide recommendations on both project and disease area levels.Qualifications
University Degree in Science or related discipline. Advanced degree preferred.Significant (10+ years) previous experience gained with a CRO and/or biopharmaceutical company working on multinational clinical studies and program strategy.Considerable (5+ years) managing clinical studies and direct reports.Must have experience leading/managing externally outsourced, cross-functional teams.Experience in clinical drug development process within clinical program planning, startup including budget and resource planning through final study report.Proven track record in resource planning forecasting and budgeting.Ability to travel up to 30%.About Alnylam:
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture:
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of Americas Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
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The Director, Clinical Operations Study Management is an effective team leader. He/she is responsible for talent development, provides line management, supervision, coaching and mentoring of team members in his/her group. He/she is responsible for building Clinical Operations, therapeutic area, and technical skills within his/her group to ensure patient safety, quality clinical trial execution and effective delivery of trials. He/she is also a member of the Clinical Operations Leadership Team (COLT) and, as such, supports and influences the direction of the Clinical Operations group.
The Director, Clinical Operations Study Management is accountable for the delivery of clinical trials within his/her assigned portfolio and for ensuring appropriate management of study vendors/CROs. He/she will collaborate with internal stakeholders on the oversight of vendors/CROs. He/she will assist in resolving and/or escalating issues as needed. He/she is responsible to ensure the assigned clinical trials are adequately resourced, sets priorities, and manages operational plans and budgets.
The Director, Clinical Operations Study Management serves as an expert in clinical operations processes and is responsible for developing and sharing best practices within his/her team and across the Clinical Operations group. He/she will work with other Clinical Operations and Expertise Area leaders to formulate strategies, standards, processes and best practices to be implemented for the benefit across Clinical Operations.
The Director, Clinical Operations Study Management ensures strong interaction with local country, medical affairs teams/regional medical groups, and other strategic partners (e.g. site networks, patient groups) as needed for the successful delivery of clinical trials.
Summary Of Key Responsibilities
Partners directly with and/or guides internal team members along with the CRO team(s) to collaborate with preclinical, regulatory affairs, medical monitoring, biometrics, medical affairs, pharmacovigilance, and/or medical writing to develop drug development strategies, protocol and study designs, and other key study and program deliverables. Has overall accountability for the development of the Clinical Operations study/project strategy and operationalization for assigned projects.Communicates program strategy, goals, and priorities across a wide range of stakeholders ensuring that each is understood and supported.Active participation as a member of the Clinical Operations Leadership Team in driving strategy and team execution.Participates in development and review of key clinical documents such as protocol, IB, ICF, Regulatory submission documents, CRF, CSR, abstract and publication, and provides direction to team members to manage the content and process, as necessary.Effectively discusses and presents study data across the Company and with development partners; collaborates with clinical development and scientists, medical writers, and investigators to write, present and/or publish data.Maintains appropriate therapeutic area technical and working knowledge of scientific and clinical operations developments.Responsible for the guidance of clinical team members, including hiring, performance management, and ongoing coaching.Develops and implements strategies to maximize study management competency and skills related to Clinical Operations trial delivery.Responsible for shaping the Clinical Operations team culture including the retention and engagement of team members.Leads teams towards departmental and project productivity and quality metrics and provides financial and management accountability; works with study team and CRO partners to ensure appropriate Change Notification/ Change Order oversight to maintain cost control.Manages the recruitment and performance of team members to support and guide them to improved strategic drug development operational efficiency, effectiveness at prioritization, and problem identification and solving.Acts as point of contact for leadership including resolution and/or escalation of issues as appropriate.Participates in, reviews, and provides direction on development of Clinical Operations plans, CRO and vendor outsourcing strategy, and key performance indicators (KPIs) with CRO.Oversees the development of tracking tools and guides team members on effective management of project teams, project budgets, study timelines, and deliverables.Guides teams and identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action.Accountable to deliver excellence in Clinical Operations Study Management for a portfolio of clinical trials, ensuring the trials progress in accordance with agreed plans.Builds relationships with key clinical trial sites/networks.Collaborates with vendor/CRO partners and internal groups in the development of and compliance with robust inspection readiness plans to ensure high quality clinical trial conduct and data integrity.Partners with Quality Assurance and Clinical Operations Oversight teams to ensure team and vendor/CRO partners consistently deliver data which supports regulatory requirements.Key Skills
Must be self-motivated and able to work independently and successfully.Must be able to successfully manage remotely based team members as needed and as part of an international development team reporting into our US-based headquarters.Able to prioritize effectively, lead and influence, with good problem-solving and planning abilities to enable teams to succeed in study start, execution and completion in a timely fashion. Must possess strong organizational skills and ability to deal with competing priorities.Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs) and ICH Guidelines.Willingness to travel internationally as required.Superb communication skills (written, verbal and presentation).Ideally a combined mix of large company best practices and small company adaptability and experience.Willingness and proven ability to work flexibly, stepping outside of immediate role responsibilities and wear ‘multiple-hats’ where needed.Confident and has the professional competence to win respect and gain credibility at all levels within and outside the Company, and capable of successfully representing the Company externally.Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.Scientific Understanding: Thorough comprehension of therapeutic mechanisms of focus and current scientific developments within his/her area of expertise to provide recommendations on both project and disease area levels.Qualifications
University Degree in Science or related discipline. Advanced degree preferred.Significant (10+ years) previous experience gained with a CRO and/or biopharmaceutical company working on multinational clinical studies and program strategy.Considerable (5+ years) managing clinical studies and direct reports.Must have experience leading/managing externally outsourced, cross-functional teams.Experience in clinical drug development process within clinical program planning, startup including budget and resource planning through final study report.Proven track record in resource planning forecasting and budgeting.Ability to travel up to 30%.About Alnylam:
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture:
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of Americas Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
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