The SVP Clinical Research will report to the Chief Development Officer (CDO) and be responsible for the advancement of multiple RNAi therapeutics through development, with a particular focus on Metabolism, Ophthalmology, early Assets including lung targets and business development and partnerships. This includes setting the overall clinical development strategy and progression from IND/CTA submission through approval and life cycle management.
The SVP Clinical Research will be responsible for working closely with colleagues across Alnylam and with our partners to inform target and indication selection, and to shape and execute clinical-regulatory strategies to efficiently advance molecules into and through clinical development. In this role, he/she will interface extensively with research, clinical, commercial and business development colleagues and external experts to conduct collaborative research efforts, obtain feedback on clinical development plans, diseases and indications, and stay abreast of new developments and competitive landscape. As molecules advance into the clinic, he/she will work with clinical development and regulatory colleagues to oversee the design and timely progression of associated clinical trials. He/she will be Alnylam's key subject matter expert at external meetings, including regulatory interactions and scientific meetings. In addition to work on metabolic, ophthalmology, early lung targets and business development programs, 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 physician drug developer with a flexible, hands-on and team-oriented style. The SVP Clinical Research will build, lead and develop a team of clinical research physicians and clinical scientists, and be a critical partner & influencer to counterparts in Research, Early Development, Regulatory, Clinical Operations, Data Sciences, Statistics, Epidemiology, Safety and other expertise areas.
As a senior member of the Clinical Development organization, the SVP Clinical Research will be part of the Clinical Development Leadership Team, will partner with the CDO and other leaders 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.
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, disease indications and advice on the relevant experiments to advance the targets into the clinic.
- Collaborate with Research, Commercial and Medical Affairs to develop robust end to end Clinical Development Plans.
- Provide oversight and leadership to clinical development sub-teams 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 Affairs, Clinical Operations, Data Sciences, Statistics, Epidemiology, Commercial 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 (protocols, clinical contributions to regulatory submissions, original articles, abstracts), and presentation materials.
- Influence internal and external audiences in a high impact, highly visible fashion.
- Represent and provide clinical development leadership for business development opportunities.
- Work with the Clinical Development Leadership Team to build and grow a highly effective development organization.
Qualifications
- A highly driven, dynamic, engaged and accomplished physician-scientist with extensive drug development & leadership experience will thrive in this role. The successful candidate will be able to think on their feet, build strong working relationships in a matrixed organization and have an entrepreneurial spirit.
- MD with strong research and clinical development background or MD PhD, Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in broad cardiometabolic indications preferred.
- Minimum 12-15 years industry drug development experience.
- Experience leading clinical development programs, and actively participating in regulatory interactions with global health authorities; prior NDA/BLA/MAA experience highly valued.
- Experience and knowledge of working with biotech/pharma partner(s).
- Current working knowledge of legal, regulatory, and compliance regulations and guidelines; well-versed in 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.
- Thrives in a 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.
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