Director, Clinical Research

Overview Alnylam is the world’s leading RNA interference (RNAi) company. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine’s Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information. The successful candidate will be a member of the clinical development team, working closely with other members of the medical research group in clinical development (medical monitor, statistician, and clinical pharmacologist, translational research) to support investigations that deliver the development strategies for more than one drug. The successful Clinical Scientist contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. In addition, the Sr. Clinical Scientist will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies. The position will report to the Vice President, CNS Clinical Development. Responsibilities: The successful candidate’s primary role will be as clinical lead in CNS programs (such as Alzheimer’s Disease, ALS and/or Huntington’s 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/Sr. Director Clinical Development will work in a matrix organization across Preclinical, Regulatory & 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. - Provide 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 fashion. Requirements: A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight. 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 essential - 1-3 years industry experience or equivalent clinical academic experience, preferably with some neurology experience, is preferred but not necessary - Sound scientific and clinical judgment - Familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practices - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues - Outstanding 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. - If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required. Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.