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Senior Director, CMC Program Management

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Job Description - Senior Director, CMC Program Management

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. 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. 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 field preferred. 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.
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