Associate Director, Emerging Modalities CMC Operations

Alnylam Pharmaceuticals•Cambridge, MA

1d•Hybrid

About The Position

The Associate Director, Emerging Modalities CMC Operations will lead cross-functional planning and operational execution for emerging modalities and other non-platform programs. This role is responsible for driving development readiness by coordinating activities across Research, CMC sub-functions, Bio(Analytical), Regulatory, and external partners, including selection and management of CDMOs. This role serves as the operational backbone for emerging modality programs, ensuring cross-functional activities are aligned to program strategy, development milestones, and external execution needs. The individual will build and manage integrated development plans, support development readiness packages, help shape external partner and CDMO strategy for early-phase programs, and ensure programs have a credible, phase-appropriate path into early development and Phase I execution. This role is intended to reduce late-stage CMC surprises, strengthen planning for emerging modalities, and enable more structured and repeatable pathways for programs beyond core RNAi.

Requirements

Bachelor’s Degree in life sciences, pharmaceutical sciences, chemical engineering, bioengineering, or related field with a minimum of 8 years of relevant industry experience.
Technical knowledge of new modalities and ability to have seamless conversation with internal and external stakeholders.
Relevant industry experience in CMC, pharmaceutical development, technical operations, program leadership, or external development.
Excellent communication skills and solid experience working on cross-functional drug development teams.
Experience managing complex timelines, dependencies, and external partners (CDMOs).
Strong understanding of early-phase CMC development and modality-related development risk.
Ability to evaluate CDMOs for early phase work and onboard partners rapidly.
Experience in working with emerging modalities such as Antibody Oligo Conjugates (AOCs), Peptide Oligo Conjugates (POCs), peptide, biologics or related platforms.
Ability to translate technical complexity into clear plans, risks & decisions for leadership.
Excellent communication, organizational, and influencing skills.

Nice To Haves

Master’s Degree is preferred.

Responsibilities

Drive cross-functional operational planning for emerging modalities through early development, including external execution at CDMOs and coordination of internal stakeholders.
Build, maintain, and track integrated timelines across Research, CMC, Manufacturing, Bio(Analytical), Regulatory, and external partners.
Partner closely with the CMC lead, Program Management, and technical subject matter experts to develop development readiness packages and aligned execution plans
Work in close collaboration with CMC sub-functions to ensure clear and phase-appropriate readiness for analytical methods, raw materials, process development, and manufacturing activities.
Help define and execute external partner and CDMO strategy for novel modalities, including partner evaluation, onboarding, and oversight.
Coordinate phase-appropriate activities to reduce program risk and support efficient progression into early clinical development and Phase I.
Identify key risks, dependencies, and operational gaps, and elevate clear recommendations to leadership.
Support governance, meeting structure, milestone tracking, and cross-functional follow-through for modality-focused programs.
Develop new tools, templates, and playbooks that improve consistency, repeatability, and decision-making across emerging modality programs.
Facilitate stakeholder alignment to support timely advance, redesign, or stop decisions before formal development entry.