Senior/Executive Director, CNS Clinical Development
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row!
The Senior/Executive Director, CNS Clinical Development reports to the Chief Medical Officer and will be responsible for overseeing the successful development of multiple molecules in the Alnylam pipeline, with a focus on RNAi therapeutics for CNS and ocular diseases. Alnylam's existing clinical pipeline is comprised of liver-directed therapies that are being developed for a variety of diseases, which have been fueled by optimized approaches to hepatic delivery of small-interfering RNAs. However, more recent breakthroughs in delivery technology have created the opportunity to use RNAi therapeutics to treat a host of devastating CNS and ocular diseases, as well.
The Senior/Executive Director, CNS Clinical Development will be responsible for working closely with colleagues across Research and Development to inform target and indication selection, and to shape clinical-regulatory strategies to efficiently advance these molecules into and through clinical development. In this role, he/she will interface extensively with research colleagues and external experts to conduct collaborative research efforts, obtain feedback on clinical development plans, and stay abreast of new developments in the field. As molecules advance into the clinic, he/she will work with clinical development colleagues to oversee the design and timely progression of associated clinical trials. In addition to work on CNS assets, the successful candidate may also have responsibilities for the development of other assets in the Alnylam development portfolio across therapeutic areas, commensurate with their experience and interests.
The ideal candidate that we seek will be a highly innovative, collaborative, scientifically-grounded and accomplished Clinical Development physician with a flexible, hands-on and team-oriented style. The Senior/Executive Director, CNS Clinical Development will have matrix team leadership responsibilities, be a critical partner to counterparts in Research, Early Development, Regulatory, Clinical Operations, Data Sciences & Statistics, Safety and other expertise areas, and will have the opportunity to build and lead a team of clinical development physicians and clinical scientists. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.
As a senior member of the Clinical Development organization, the Senior/Executive Director, CNS Clinical Development also will partner with the CMO and others to help build and lead a world-class, development organization as Alnylam grows toward realizing its vision of becoming a global, fully integrated, multi-product, biopharmaceutical company.
Summary of Key Responsibilities
Be a strategic clinical leader responsible for shaping creative and efficient clinical development strategies for multiple pipeline assets
Collaborate with Research and Early Development to identify drug targets and disease indications, and shape clinical development plans
Lead one or more clinical development teams, initially via matrix leadership, and ultimately via direct management of other MDs and clinical scientists
Play a leadership role in regulatory interactions to advance molecules through development and secure global regulatory approvals
Collaborate closely with Early Development, Regulatory, Clinical Operations, Data Sciences & Statistics, Medical Affairs and Commercial 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
Influence internal and external audiences in a high impact, highly visible fashion
Work with the Clinical Development Leadership Team to build and grow a highly effective development organization
A highly driven, dynamic, engaged and accomplished Clinical Development physician with solid drug development & leadership experience will thrive in this role. The successful candidate will be able to think on their feet, build strong working relationships and have an entrepreneurial spirit. Specific qualifications include:
MD with a strong research background or MD, PhD; specialty training in Neurology preferred. Experience in Genetics and/or Rare Diseases is desirable
Minimum 5-10 years of Clinical Development experience required. Previous experience in CNS drug development is highly preferred.
Experience leading clinical development programs, and actively participating in regulatory interactions with global health authorities; prior NDA/BLA/MAA preferred but not required.
Current working knowledge of legal, regulatory, and compliance regulations and guidelines; familiarity with concepts of clinical trial design, execution and statistics
Adaptable and able to effectively lead, collaborate and influence across a complex matrix organization.
Demonstrated leadership in ambiguous situations; able to inspire a team to excel by fostering a climate of energy, excitement and personal accountability.
Excellent written and verbal communication skills
Excited to work in a highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.