Director, Clinical Science CNS

Alnylam Pharmaceuticals; Cambridge; Hybrid; GBP 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a Director of Clinical Scientist in the Central Nervous System therapeutic area. This strategic role offers the chance to shape clinical development plans and protocols for groundbreaking RNAi-based medicines. The successful candidate will collaborate with clinical teams, ensuring the scientific integrity of trials while engaging with regulatory agencies and external partners. Join a company recognized for its inclusive culture and commitment to pioneering medical advancements, where your contributions will directly impact patient care and therapeutic innovation.

Qualifications

• 6+ years of experience in clinical R&D, particularly in neuropsychiatric diseases.
• Strong knowledge of global clinical development and regulatory processes.

Responsibilities

• Develop strategic documents for clinical development plans and protocols.
• Communicate with health authorities regarding INDs and NDAs.

Skills

Clinical Research

Drug Development

Leadership

Collaboration

Communication

Biostatistics

Education

Master's Degree

PhD

MD

PharmD

Job description

This role is considered Hybrid.

Overview

Alnylam Pharmaceuticals is seeking an innovative clinical scientist drug developer for the position of Director, Clinical Scientist - Central Nervous System (CNS) therapeutic area. This role offers a strategic opportunity to contribute to Alnylam's expanding portfolio of RNAi-based medicines for CNS diseases.

The successful candidate will collaborate with clinical development teams of physicians and scientists within the CNS area, serving as a clinical research expert across various phases of clinical development. They will ensure the scientific integrity and quality of their clinical trials.

Within a matrixed environment, the Director will influence the development plan, including trial design, protocols, and study execution. They will engage with regulatory agencies, strategic partners, patient advocacy groups, advisory boards, and external consultants. Additionally, they may work with R&D to evaluate new targets in early clinical development. The role also involves representing Alnylam at external scientific and regulatory meetings.

Key Responsibilities

• Develop strategic documents such as clinical development plans and protocols for early and late-stage products.
• Contribute to key clinical and regulatory documents, including Investigator's Brochures and safety updates.
• Communicate with health authorities regarding INDs, NDAs, and responses to queries.
• Gain knowledge of clinical endpoints, scales, biomarkers, and assay characteristics relevant to assigned programs.
• Ensure studies comply with GCP, ethical standards, and safety monitoring.
• Lead investigator meetings, protocol training, and trial-related advisory boards.
• Forecast resource needs and analyze study data to inform development decisions.
• Manage investigator-initiated trials and assist in outsourcing and CRO selection.

Qualifications

• Master's, PhD, PharmD, or MD with a strong background in clinical research or drug development.
• Minimum 6 years of industry experience in clinical R&D, preferably in neuropsychiatric diseases.
• Knowledge of global clinical development, trial design, biostatistics, and regulatory processes.
• Proven leadership, collaboration, and communication skills.
• Experience in mid- to late-stage clinical programs and interactions with regulatory agencies.

About Alnylam

Alnylam Pharmaceuticals (Nasdaq: ALNY) pioneers RNA interference (RNAi) therapeutics, transforming genetic diseases with Nobel-winning science. Since 2002, we've led the RNAi revolution, turning scientific potential into real medicines.

Our Culture

Our people-first culture is driven by core values: innovation, openness, urgency, excellence, and inclusivity. Recognized globally as a top employer, we foster an environment where diverse perspectives thrive, enabling groundbreaking medical advances.

We are committed to equal opportunity and creating a workplace where all employees feel valued, authentic, and empowered to reach their full potential.