Sr. Director, Clinical Science

Seeking an experienced Senior Director, Clinical Science role who holds a leadership position within the Clinical Science organization at Alnylam.

The Senior Director reports directly to the Group Head, Clinical Science and plans, implements, and manages assigned clinical programs/studies in collaboration with internal and external stakeholders for successful delivery. This is an exciting leadership role contributing to the design and execution of the company's clinical programs/studies and may also be responsible for spearheading Clinical Science group in the CardioMetabolism (CM) therapeutic area. Hence the role requires robust & rich experience in Phase 1-3 clinical development in CM space, with preferred knowledge and experience in executing large multination randomized cardiovascular outcome trials. Moreover, this role offers the unique opportunity to collaborate closely with x-EA teams or external development partner(s) at the enterprise level, thereby enhancing the overall impact and reach of the position.

Key Responsibilities

• Provide strategic inputs and support for clinical development plan in partnership with x-EA teams, author study-related documents, monitor patient data collection status and perform clinical data review along with DSS and Clinical Operations to ensure adherence to study protocol and quality data collection

• Work closely with the clinical and scientific experts (both internally and externally) in developing study related documents (e.g. study protocols, informed consent forms, case report forms, regulatory documents, study report, safety review and data communication & publication plans)

• Support preparation of regulatory submissions necessary for the initiation of clinical studies by authoring/managing/reviewing study materials and deliver protocol-related training to CROs and clinical trial sites
• Lead or support the assigned Clinical Scientist(s) in developing study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring Committees throughout the life cycle of a program
• Contribute to the preparation of the clinical sections of regulatory submission documents such as briefing documents, IND/NDA/BLA dossiers, etc.

• Maintain knowledge of the therapeutic area(s), current medical practice, and pharmaceutical regulations to help ensure best practices

• Establish excellent communication and collaboration with the x-EA partners within and outside of Alnylam
• Work closely with Group Head, Clinical Science to build, expand and grow the Clinical Science group within the CM therapeutic area
• Supervise Clinical Scientists in the therapeutic area(s) by overseeing the quality and effectiveness of Clinical Science Team, including their collaboration with Clinical Research MDs, Clinical Operations and Program Leadership Team, et al., and facilitate knowledge of best practices, lessons learned and issue escalation

• Participate in Clinical Trial Review Board, Development Operation Council and/or Product Development Board on the assigned program/studies

Qualifications

• Minimum of a college in life sciences or nursing degree, advanced degree preferred (i.e. MD, PhD, PharmD or MS)
• Minimum 10 years of clinical research and drug development experience within the industry (pharmaceutical or biotech organizations)
• Managerial experience in leading the team, including in a matrix setting
• Extensive experience in drug development across all phases with strong knowledge of clinical trial design & methodology, regulatory and compliance requirements governing clinical trial conduct
• Track record of successfully executing multiple phase 2 and pivotal phase 3 programs; (s)NDA submission and HA inspection experience is a plus
  • Prior experience of working on large global cardiovascular outcomes trials ( 4,000 patients) is preferred
• Proven capabilities and knowledge in clinical study protocol development, case report forms, informed consent, study initiation, data review & monitoring, and study reporting
• Demonstrated ability to establish strong scientific partnership and influence/align with the key collaborators and cross-functional stakeholders, and lead implementation of new development processes and roles related to Clinical Science function
• Demonstrated abilities in data integrity, exploration, analysis, and presentation
• Excellent written communication, oral communication, and presentation skills are required
• Ability to travel (including international travels) up to 20% is required

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.