Alnylam Pharmaceuticals
Director, Clinical Research
Alnylam Pharmaceuticals, Cambridge, Massachusetts, us, 02140
This role is considered Virtual.Overview
Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their particular expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam's rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases and hepatic infectious diseases.
The successful candidate's primary role will be as clinical lead in multiple early phase or a late phase clinical development program in a rare genetic or cardio-metabolic disease. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the molecules and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam's research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs.The Director Clinical Research will work in a matrix organization across Regulatory , Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.Summary of Key Responsibilities
Be the strategic leader providing a strong, clear voice for the clinical
program.Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.Oversight of trial conduct and
safetyProvide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.Be responsible for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms.Influence internal and external audiences in a high impact, highly visible
fashionQualifications
A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:MD with strong research background or MD PhD, with best of class clinical and/or research training as shown through research support and peer review publications. Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in rare diseases would be a great advantage, but not essential3+ years industry experience or equivalent clinical academic
experienceEndocrinology experience preferredSound scientific and clinical
judgmentFamiliarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practicesAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesOutstanding leadership and collaboration skills working within a matrix
environment.Experience and knowledge of working with biotech/pharma
partner(s).Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency.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 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.>#J-18808-Ljbffr
Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their particular expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam's rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases and hepatic infectious diseases.
The successful candidate's primary role will be as clinical lead in multiple early phase or a late phase clinical development program in a rare genetic or cardio-metabolic disease. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the molecules and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam's research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs.The Director Clinical Research will work in a matrix organization across Regulatory , Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.Summary of Key Responsibilities
Be the strategic leader providing a strong, clear voice for the clinical
program.Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.Oversight of trial conduct and
safetyProvide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.Be responsible for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms.Influence internal and external audiences in a high impact, highly visible
fashionQualifications
A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:MD with strong research background or MD PhD, with best of class clinical and/or research training as shown through research support and peer review publications. Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in rare diseases would be a great advantage, but not essential3+ years industry experience or equivalent clinical academic
experienceEndocrinology experience preferredSound scientific and clinical
judgmentFamiliarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practicesAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesOutstanding leadership and collaboration skills working within a matrix
environment.Experience and knowledge of working with biotech/pharma
partner(s).Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency.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 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.>#J-18808-Ljbffr