Director, Clinical Research

Alnylam; Schweiz; Hybrid; CHF 180,000 - 250,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. seeks an imaginative physician drug developer to lead clinical research in neurology and hematology, shaping RNAi therapeutics across rare genetic and common diseases.

The Director, Clinical Research, will drive progress and provide a leadership voice in global regulatory strategy and external engagements. The role centers on leading the plasminogen program from Phase 2 to Phase 3, with matrix collaboration across Regulatory, Biostatistics, Clinical Operations,

Qualifications

• MD with strong research background or MD PhD with best of class clinical/research training as shown through research support and peer-reviewed publications.
• Board Certification (or equivalent) in neurology is desirable
• 3+ years industry experience or equivalent clinical academic research experience
• Familiarity with clinical research concepts including biostatistics and regulatory guidelines
• Ability to present complex medical concepts clearly in writing and speaking

Responsibilities

• Be a subject matter expert for the relevant disease areas.
• Provide strategic leadership for the clinical program.
• Develop creative approaches to drug development and drive regulatory approvals.
• Oversee trial conduct and safety.
• Collaborate with Preclinical, Regulatory Affairs and Medical Affairs for integrated product development plans.
• Ensure timely delivery of timelines and deliverables.
• Review and sign off on all controlled documents (protocols, investigator brochures, consent forms).
• Influence internal and external audiences in a high-impact setting.

Skills

MD/MD-PhD

Neurology specialization

Clinical leadership

Regulatory knowledge

Biostatistics understanding

Education

MD/MD-PhD with neurology train

Board Certification in neurology

Job description

Overview

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work across diseases within the neurology and hematology therapeutic area. This role includes the opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam's expanding portfolio, which spans from rare genetic to common diseases.

The successful candidate's primary role will be one of the clinical study leads working on the plasminogen program transitioning from Phase 2 to Phase 3. The Director will report directly into the program clinical development strategy lead who provides the clinical research oversight of the program. The Director is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence of his/her clinical trial(s). This work will also involve extensive consultation and collaboration with external experts. The Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & Quality Assurance teams to ensure fully harmonized and integrated development strategies. The Director will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.

Key Responsibilities

• Be a subject matter expert for the relevant disease area(s)
• 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 towards global regulatory approvals
• Oversight of trial conduct and safety
• 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, investigator brochures, and informed consent forms.
• Influence internal and external audiences in a high impact, highly visible fashion

Qualifications

A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. 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-reviewed publications.
• Board Certification (or equivalent) or specialist training in neurology is desirable
• 3+ years industry experience or equivalent clinical academic research experience
• Sound scientific and clinical judgment
• Familiarity with concepts of clinical research and clinical trials, 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 critical thinking and problem solving while exhibiting superior judgment and a balanced, realistic understanding of issues
• Outstanding leadership and collaboration skills working within a matrix environment
• Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency.

#LI-JB1 #LI-Hybrid

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 f