Alnylam Pharmaceuticals
Associate Director, Clinical Trial Disclosure and Transparency
Alnylam Pharmaceuticals, Cambridge, Massachusetts, us, 02140
This role is considered Hybrid.The Associate Director of Clinical Trial Disclosure and Transparency provides leadership and oversight of key Alnylam Clinical Trial Disclosure and Transparency processes and deliverables. This includes but is not limited to planning, implementation, and oversight of the plain language summaries and their related processes, data publication redaction/anonymization, patient-level data sharing and other deliverables as needed. This position is a highly visible role integrated in transparency-related activities across the global organization.Responsibilities:
Serves as a leader and subject matter expert for Clinical Trial Disclosure and Transparency regulations and activities.Plans and executes Clinical Trial Disclosure and Transparency activities to ensure Alnylam sponsored trial information is disclosed in accordance to global applicable laws, regulations, policies, and the Alnylam Clinical Trial Transparency Policy.Proactively plans and maps Alnylam Plain Language Summary workload; where needed, expertly authors protocol and results plain language summaries.Develops and enhances plain language glossaries and other tools in support of more efficient and accurate plain language summary development.Proactively plans and maps EU CTR, data publication and other document anonymization/redaction activities; where needed, expertly redacts documents for submission to regulatory bodies, journals and other entities.Anticipates and identifies areas of change, assesses potential impact, proposes strategic adaptability, and leads and oversees change management efforts.Monitors, communicates, and plans responses for changes in global Clinical Trial Disclosure and Transparency regulations.Collaborates with cross-functional stakeholders (Clinical Operations, Clinical Research, Patient Recruitment & Retention, Global Patient Safety & Risk Management, Biostatistics, Statistical Programming, Regulatory Affairs, Investor Relations, and Legal) along with Contract Research Organizations (CROs).Proactively plans and executes outsourcing, resourcing, risk management, and technology strategies that ensure the timely and high-quality delivery of activities required for transparency compliance and facilitates process for sharing clinical data within a defined process.Engenders a transparency mindset in the organization, developing, tracking and actioning regulatory learnings over time, and sharing the resulting knowledge across relevant expertise areas.Demonstrates leadership and management of aligning stakeholders, driving decisions, and keeping requirement definition and implementations focused and on-time.Optimizes and oversees the implementation of Standard Operating Procedures (SOPs), policies, processes, communication, and infrastructure to function as a quality-driven organization.Assists clinical trial teams, expertise areas, and management with questions regarding public results disclosure and trains the organization on transparency and disclosure processes.Qualifications:
Bachelor's degree in science, health profession, or communication; advanced degree and/or professional credentials preferred.7+ years working in pharmaceutical, biotechnology, health care, or medical industry.Demonstrated experience along with sound practical understanding of clinical trial disclosure and data transparency activities and regulations.Strong leadership, planning, and project management experience, along with initiative and ability to be productive with minimal supervision and minimal administrative support.Excellent communication skills, demonstrating diplomacy, reasoning and problem-solving within the group and when working across other functions.Desire and aptitude to create and execute clinical disclosure and transparency procedures.Knowledge of clinical development, regulatory affairs, and/or clinical trial execution processes, including the phases, protocol design through regulatory submissions, and scientific methodology.Regulatory knowledge, including Good Clinical Practices (GCPs), ICH guidelines, and clinical trial disclosure requirements.Ability to communicate and build relationships at all levels within the organization.Strong thinker with good facilitation skills supported by excellent interpersonal competencies (leadership, influencing).Experience working in a fast-paced entrepreneurial environment.Demonstrate clear alignment with Alnylam Core Values including:Commitment to PeopleInnovation and DiscoveryPurposeful UrgencyOpen CulturePassion for ExcellenceAbout 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 America's 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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Serves as a leader and subject matter expert for Clinical Trial Disclosure and Transparency regulations and activities.Plans and executes Clinical Trial Disclosure and Transparency activities to ensure Alnylam sponsored trial information is disclosed in accordance to global applicable laws, regulations, policies, and the Alnylam Clinical Trial Transparency Policy.Proactively plans and maps Alnylam Plain Language Summary workload; where needed, expertly authors protocol and results plain language summaries.Develops and enhances plain language glossaries and other tools in support of more efficient and accurate plain language summary development.Proactively plans and maps EU CTR, data publication and other document anonymization/redaction activities; where needed, expertly redacts documents for submission to regulatory bodies, journals and other entities.Anticipates and identifies areas of change, assesses potential impact, proposes strategic adaptability, and leads and oversees change management efforts.Monitors, communicates, and plans responses for changes in global Clinical Trial Disclosure and Transparency regulations.Collaborates with cross-functional stakeholders (Clinical Operations, Clinical Research, Patient Recruitment & Retention, Global Patient Safety & Risk Management, Biostatistics, Statistical Programming, Regulatory Affairs, Investor Relations, and Legal) along with Contract Research Organizations (CROs).Proactively plans and executes outsourcing, resourcing, risk management, and technology strategies that ensure the timely and high-quality delivery of activities required for transparency compliance and facilitates process for sharing clinical data within a defined process.Engenders a transparency mindset in the organization, developing, tracking and actioning regulatory learnings over time, and sharing the resulting knowledge across relevant expertise areas.Demonstrates leadership and management of aligning stakeholders, driving decisions, and keeping requirement definition and implementations focused and on-time.Optimizes and oversees the implementation of Standard Operating Procedures (SOPs), policies, processes, communication, and infrastructure to function as a quality-driven organization.Assists clinical trial teams, expertise areas, and management with questions regarding public results disclosure and trains the organization on transparency and disclosure processes.Qualifications:
Bachelor's degree in science, health profession, or communication; advanced degree and/or professional credentials preferred.7+ years working in pharmaceutical, biotechnology, health care, or medical industry.Demonstrated experience along with sound practical understanding of clinical trial disclosure and data transparency activities and regulations.Strong leadership, planning, and project management experience, along with initiative and ability to be productive with minimal supervision and minimal administrative support.Excellent communication skills, demonstrating diplomacy, reasoning and problem-solving within the group and when working across other functions.Desire and aptitude to create and execute clinical disclosure and transparency procedures.Knowledge of clinical development, regulatory affairs, and/or clinical trial execution processes, including the phases, protocol design through regulatory submissions, and scientific methodology.Regulatory knowledge, including Good Clinical Practices (GCPs), ICH guidelines, and clinical trial disclosure requirements.Ability to communicate and build relationships at all levels within the organization.Strong thinker with good facilitation skills supported by excellent interpersonal competencies (leadership, influencing).Experience working in a fast-paced entrepreneurial environment.Demonstrate clear alignment with Alnylam Core Values including:Commitment to PeopleInnovation and DiscoveryPurposeful UrgencyOpen CulturePassion for ExcellenceAbout 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 America's 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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