Senior Director, CMC Program Management

Overview

This role will oversee the development and execution of the overall strategy for novel siRNA conjugate programs, which includes small molecules, peptides and protein ligands. Working closely with other departments, including clinical development, regulatory affairs, and manufacturing, the candidate will be responsible to facilitate a seamless transition of novel conjugate programs into clinical trials. The candidate will bring a deep knowledge of protein and peptide conjugates, coupled with extensive drug development experience to help define the clinical development strategy and determine the required pre-clinical and regulatory requirements leading to initation in clinic.

This position is hybrid and will be primarily located in Cambridge, MA.

Key Responsibilities

• Drive coordination of cross-functional activites, both internal and partnered, to develop and advance novel siRNA conjugates into clinical studies.
• Partner closely with Research, Development, and Technical Operations & Quality (TOQ) leadership to shape and execute the novel conjugate program strategy, goals and plans, and ensure tight alignment with company goals.
• Lead development and drive execution, advancing the program by parterning with Program Management to establish workplans/timelines and integrate development plans with milestones/goals, key events, risks/assumptions, and scenarios.
• Closely align with finance on all financial aspects of the program, including liaising with collaborating partners.
• Provide expertise on novel siRNA conjugate development including antibody discovery, expression & purification and peptide synthesis and purification developments.
• Integrate cross-functional perspectives, ensuring that program development strategy is informed by scientific evidence, clinical data, and the changing competitive landscape.
• Proactively anticipate issues and ensure contingency plans are put in place; identify barriers and solutions to mitigate them; identify opportunities and strategies to capitalize on them.
• Working with Expertise Area (EA) leaders, ensure that appropriate prioritization and adequate resource allocation (financial and people) are applied to meet the program timelines and deliverables.
• Serve as an internal and external ambassador for the program, fostering broad engagement to cultivate strategic KOL relationships and enable overall integration of external insights to inform program strategies.
• Summarize and represent the program to Alnylam leadership, Board of Directors, alliance partners, collaborators, and other external parties as requested.

Qualifications

• Minimum 12 years experience in the pharmaceutical or biotechnology industry with knowledge of the drug discovery, research, and development processes. Advanced degree in medicine, pharmacy, chemistry, or a related life science fieldpreferred.
• Extensive experience in clinical drug development, ideally across different phases of clinical trials
• Strong background in protein chemistry, peptide chemistry, conjugation chemistry, analytical techniques and antibody expression and purification
• Proven leadership skills with the ability to manage complex projects and cross-functional teams
• Excellent communication and interpersonal skills to collaborate effectively with diverse stakeholders and senior leadership. Strong problem-solving abilities and the capacity to work effectively in a multi-disciplinary matrix environment.
• Excellent written and oral communication, including presentation and facilitation skills.
• Strong analytical and problem-solving skills; ability to combine attention to detail within broader strategic context.
• Superior collaboration and negotiation skills, and high degree of self-awareness and executive presence.
• Ability to thrive in a fast-paced environment with strong ability to simultaneously handle multiple activities, prioritizing and pivoting as necessary.
• Passion for helping patients and developing transformative treatments for patients in need; motivated by patient focus and personal commitment to high performance and results.

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.