Executive Director, Clinical Science

Seeking an experienced Clinical Science Group Head role to build and expand the Clinical Science capabilities within Clinical Development EA.
This role requires a seasoned clinical development leader with a track record of successfully mentoring and developing Clinical Scientists within the biotech or pharmaceutical industry. A robust & rich experience in Phase 1-3 clinical development including executing randomized multi-nation cardiovascular outcome trials is preferred. He/she will be responsible for oversight and resource allocation of the entire Clinical Scientists function within Clinical Development, drive functional excellence through process improvement, resource prioritization & forecasting, and knowledge sharing, etc. The Clinical Science Group Head partners with Clinical Development and/or Clinical Research TA Heads to bridge with key stakeholders within the R&D organization for successful delivery of the Alnylam development portfolio.

Key Responsibilities

* Establish Clinical Science as a valued scientific leadership line function within Clinical Development EA

* Hire, onboard, train, manage and develop a high-performing group of Clinical Scientists that are seen as valued scientific partners in the design and execution of clinical programs; Lead job profile optimization and build best talents and an empowered culture to foster high performance in a matrix environment

* Partner with Clinical Development and/or Clinical Research TA Heads as well as other EA Heads (Clinical Operations, DSSE, etc.) or CROs to define cross-functional ways of working with Clinical Science team and resource clinical programs effectively through maintaining a strong portfolio view and agile & innovative resourcing methodologies to prioritize/staff clinical programs across all TAs

* Oversee the quality and effectiveness of the Clinical Science Team, including their collaboration with Clinical Research MDs, Clinical Operations and Program Leadership Team, et al., in the planning and execution of Clinical Development Plan; Serve as the point of contact for Clinical Science associates regarding knowledge of best practices, lessons learned and issue escalation

* Build the standards and tools for Clinical Scientists to ensure clinical relevancy and interpretability of data through the authorship of core study documents (e.g., protocol concepts and full study protocols, informed consent forms, eCRFs) and the creation & execution of critical study plans (e.g., data review & cleaning plans)

* Ensure the accountability of Clinical Science EA on quality of clinical trial data for clinical review and interpretation to achieve regulatory reporting/filing milestones

* Support the assigned Clinical Scientist(s) in facilitating the scientific content and discussion for Advisory Board / Scientific Committee Meetings & Investigators Meetings throughout the lifecycle of a program

* May serve as a Clinical Science Program Lead on the study level of large cardiovascular outcome trial(s) as needed, and oversee the work of Associate Directors and/or Clinical Scientists working on the same or related program(s)

* Participate in Clinical Development Leadership Team, Clinical Trial Review Board and Development Operation Council, as a core or extended member

Qualifications

* Advanced degree in a scientific discipline (i.e. MD, M.S, Ph.D. or Pharm.D.) is required

* A minimum of 10 years of clinical research and development, or related experience within the industry (pharmaceutical or biotech) is required

* The individual must have demonstrated ability to lead a team with track record of building a Clinical Science group/function and budget/resource accountabilities

* Extensive experience in drug development across all phases with strong knowledge of clinical trial design & methodology, regulatory and compliance requirements governing clinical trial conduct

o Past experience in leading Clinical Science team in cardiovascular outcome trial(s) is preferred

* Track record of successfully managing multiple phase 2 and pivotal phase 3 programs; submission and HA inspection experience is a plus

* 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

* Proven capabilities and knowledge in clinical study protocol development, case report forms, informed consent, study initiation, and data review & monitoring

* 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 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.