Senior Medical Director, Clinical Research - Hepatology

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam\u2019s rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology.\n\n \n\nThe successful candidate\u2019s primary role will be to drive the pipeline forward through leadership of clinical development programs. While the primary focus responsibility will be as clinical lead physician on Alnylam\u2019s autoimmune liver disease programs, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve. He/she is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam\u2019s 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.\n\n \n\nThe Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial \u0026 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.\n\n \n\nThis position is hybrid and will be primarily located at our Cambridge, MA headquarters or Maidenhead, UK location.\n\n \n\nKey Responsibilities\n\n * Be the strategic leader providing a strong, clear voice for the clinical programs\n * Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals\n * Oversight of trial conduct and safety \n * Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications. \n * Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plans\n * Be accountable via Clinical Research and Operations for all relevant timelines and deliverables\n * Drive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials\n * Be responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms\n * Influence internal and external audiences in a high impact, highly visible fashion\n\n\n\n \n\nQualifications\n\n * MD with strong research background or MD PhD, with a track record of successful research support and peer review publications. Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in hepatology (autoimmune liver disease) would be a great advantage, but not essential\n * 10+ years industry experience or equivalent clinical academic experience\n * Sound scientific and clinical judgment\n * Successful track record of leading Phase 2/3 clinical programs, including major interactions with Health Authorities \n * Familiarity with concepts of clinical research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practices\n * Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n * History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues\n * Outstanding leadership and collaboration skills working within a matrix environment.\n * Experience and knowledge of working with biotech/pharma partner(s) a plus\n * Thrives in highly entrepreneurial biotech environment and embraces Alnylam\u2019s culture of science, passion and urgency.\n\n\n\nAbout 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 \u201cinterfering\u201d 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.\n\nOur 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\u2019ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine\u2019s Top Biopharma Employers, one of America\u0027s 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 \u2013 among others.\n\nAt 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.\n