Director, Clinical Research

Overview

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer for the role of Director, Clinical Research - Central Nervous System (CNS) therapeutic area. This is an opportunity to assume a foundational and strategic role in building Alnylam’s rapidly expanding portfolio of transformative, RNAi-based medicines for CNS disease.

The successful candidate will join a clinical development team of physicians and clinical scientists within the CNS therapeutic area, whose primary role will be as clinical lead in one or more of its global early- through late-phase clinical development programs. He/she/they will be expected to play a leading and influencing role to drive the progress and operational excellence of its associated clinical trials.

Working within a matrixed environment, the Director will be a key clinical contributor to the global product development plan, including the clinical development plan, clinical trial design, study protocol, and clinical study execution. He/she/they will also be a key contributor to correspondence with health authorities/regulatory agencies (IND, NDA, label negotiations, etc) and participate in the navigation of key strategic partnerships, patient advocacy alliances, advisory boards, and a network of external consultants and experts. He/she/they may also work with Alnylam’s research and discovery group to advise on the clinical development feasibility of novel targets and the design of proof-of-concept studies associated with bench-to-bedside early phase clinical development programs. He/she/they will be expected to be a key Alnylam R&D spokesperson at external meetings, including regulatory interactions and scientific meetings.

Key Responsibilities

• Provide strategic leadership and advocacy for global clinical development programs
• Ensure strategic integration of product development plans, in close collaboration with Preclinical, Regulatory Affairs and Medical Affairs
• Design creative but realistic clinical development plans and clinical trial concepts
• Share accountability for timelines and deliverables via Clinical Research and Operations
• Ensure oversight of trial conduct quality and safety
• Contribute to controlled clinical trial documents including Protocols, Investigator Brochures, and Informed Consent Forms
• Provide clinical leadership to secure global regulatory approvals
• Contribute to major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials
• Strategic consultation and clinical guidance to Research on early-stage assets
• Participate in the creation and delivery of high-impact presentations and informal contacts to Influence internal and external audiences
• Provide mentorship and guidance to other members of the clinical development team, and research and development where needed
• Be a leader in ensuring a safe and inclusive work environment that cultivates participation and contributions to the full potential of team functions and members

Qualifications

A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:

• Physician with clinical training and a strong research background, or MD PhD
• Board Certification (or equivalent) or specialist training in Neurology is preferred
• Industry experience (4+ years) in clinical R&D focused on CNS disease, or equivalent clinical academic experience
• Demonstrable track record of productive clinical research (i.e., research support and/or primary authorship in peer reviewed publications)
• Strong familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organizations, guidelines, and practices
• Demonstrable track record documenting ability to convey complex medical/clinical concepts in both written and oral communication
• Professional history of significant clinical or scientific contributions to project milestones
• Professional history of 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 can embrace 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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.