Sr. Director, Clinical Research-Early Clinical Support

Overview

Alnylam Pharmaceuticals is seeking an imaginative physician scientist and drug developer in Clinical Research - Cardiovascular therapeutic area, focusing on early clinical development including but not limited to target & development candidate nomination via close collaborations with Research team, developing early clinical development plans, translational research and biomarker strategy, etc.

This is an opportunity to provide clinical leadership as a key bridge between Research, Clinical Development and Commercial organization, and to work closely with TA Head driving the strategy for the CV Therapeutic Area in alignment with the broader organization developing breakthrough RNAi therapeutics emerging from Alnylam’s rapidly expanding pipelines. This role may also work in therapeutic areas that are beyond their CV expertise or experience.

The successful candidate’s primary role will be serving as the Clinical Research lead on Early Project Team(s) supporting significant interactions with Alnylam’s Research group, helping to advise the team on the clinical developability of novel targets and the design of first-in-human (FIH) and proof-of-concept (POC) studies. This work will also involve extensive consultation and collaboration with external experts. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the CV and other therapeutic area(s), and to drive the portfolio expansion and advance into clinic POCs.

The Sr. Director Clinical Research will work in a matrix organization across Research/Early Development, Regulatory, Biostatistics, Clinical Operations, Commercial & QA teams to ensure fully harmonized and integrated development strategies. He/she will also be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.

Key Responsibilities

• Serve as a strategic leader providing strong science and data-driven Clinical Research voice for early projects/programs.
• Provide strategic guidance and expert consultations to the Research team on all decisions that have significant clinical components and implications
• Deliver clear Clinical Research inputs (indication, patient population, FIH/PoC plan, Go/No Go criteria, etc.) for decisions on new target & development candidate during the major internal governance/board interaction
• Closely collaborate with Research, Early Development, Regulatory Affairs and New Product Commercial and other EAs to ensure strategic alignment on early clinical development plans
• Be accountable for establishing the biomarker strategy for CV therapeutic area
• May serve as medical monitor with oversight of trial conduct and safety or CDST (Clinical Development Sub-Team) lead on an assigned clinical program/study with overall accountability for the clinical development plan
• Bring in relevant external opinion leaders to advise the proposed plan through clinical POC
• May participate in business development activities and licensing due diligence review by providing senior level expertise

Qualifications

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

• MD or MD PhD with Board Certification (or equivalent) in Medicine; specialty training in Cardiovascular Medicine preferred
• 5+ years industry experience in translational medicine within the Pharma/Biotech organization, with major experience driving translational clinical research from FIH through POC studies
• Ability to develop state-of-the-art clinical development plan (CDP) and to navigate through internal governance boards in securing strategic approval of early CDPs including biomarker strategy
• Strong medical monitoring skills and sound scientific and clinical judgment
• Experience leading in a matrixed environment successfully supporting and influencing experts, scientists and project deliveries across Research, Clinical Development and Commercial organizations
• Strategic thinker in creating innovative ideas, networking with leading investigators, presenting complex strategic issues in a clear and logical way and driving impactful outcomes
• Experience and knowledge of working under strategic alliance with Biotech/Pharma partner(s) is a plus
• Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science & innovation, passion for excellence and purposeful 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.