Director, Clinical Science CNS

This role is considered Hybrid.

Overview

Alnylam Pharmaceuticals is seeking an imaginative clinical scientist drug developer for the role of Director, Clinical Scientist - Central Nervous System (CNS) therapeutic area. This is an opportunity to assume a foundational and strategic role in building Alnylam's rapidly expanding portfolio of transformative, RNAi-based medicines for CNS disease.

The successful candidate will work closely with one or more clinical development teams of physicians and clinical scientists within the CNS therapeutic area, whose primary role will be to serve as a clinical research expert in one or more of its global early- through late-phase clinical development programs. In addition, he/she/they will be expected to be a key driver of the scientific integrity and quality of their assigned clinical trials.

Working within a matrixed environment, the Director, Clinical Scientist will be a cross-functional influencer in the maturation of the global product development plan, including the clinical development plan, clinical trial design, study protocol, and clinical study execution. He/she/they will also be a contributor to correspondence with health authorities/regulatory agencies (IND, NDA, label negotiations, etc) and participate in the navigation of strategic partnerships, patient advocacy alliances, advisory boards, and a network of external consultants and experts. He/she/they may also work with Alnylam's research and discovery group to evaluate the development feasibility of novel targets in early phase clinical development programs. In addition, he/she/they will be expected to be an Alnylam R&D spokesperson at external meetings, including health authorities and at scientific meetings, as well as being an emerging influencer of the evolving science supporting the clinical research in the assigned program indications.

Key Responsibilities

The Director, Clinical Scientist will be fully conversant with the fundamental stages and principles of drug development, the principles of pharmacologic action, the design and execution of well-controlled clinical trials, and the fulfillment of regulatory requirements while observing Good Clinical Practice (GCP); and will apply this expertise within a matrixed clinical research and development setting, to include the following:
* Work with the Therapeutic Area Head (CNS) as well as Medical Director(s), to create key strategic documents, including the clinical development plan, protocol concept and full protocol for one or more products in early stage development, while also contributing to product(s) in later stages of development, including NDA filings
* Contribute to the key documents describing products in development, such as the Investigators' Brochure and safety updates
* Contribute to correspondence with the health authorities approached by the assigned programs, such as the briefing book, IND, NDA, as well as responses to health authority questions
* Develop a working knowledge of the operational characteristics of the clinical endpoints relevant to the assigned clinical trial indication, the study population represented by various inclusion/exclusion criteria or diagnoses, and their use in previous clinical trials, to enable informed and innovative clinical trial design
* Develop a working knowledge of the clinical scales and patient reported outcome tools associated with the assigned clinical trial indication in order to facilitate their qualification and justification for regulatory correspondence and study start up activities
* Develop a working knowledge of the biomarkers and other measured endpoints associated with the assigned clinical programs, their assay characteristics, sample handling requirements, and qualification needs, if any
* Monitor regulatory policies and guidance to ensure scientific quality/innovation of clinical study design, execution, reporting and publication
* Ensure that all studies observe the highest standards of ethical and safe conduct, and ensure compliance with GCP; monitor study progress and perform medical data review to ensure integrity of study data and appropriate safety follow-up
* Plan and participate in investigators meetings and protocol training meetings
* Develop effective working relationships with investigators in assigned programs
* Prepare and run dose escalation meetings with investigators (phase 1)
* Lead or contribute to trial-related advisory boards
* Assist in forecasting trial resource needs
* Analyze and interpret study data from an individual study; translate study level clinical data across the program of studies for a particular drug
* Facilitate the awareness of the real-time availability of clinical trial data (including safety, efficacy, pharmacokinetic and biomarker data), to provide consolidated information for dose escalation meetings, data safety monitoring boards, and interim analyses
* Set up and manage investigator initiated clinical and/or pre-clinical trials
* Assist Clinical Operations in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties

Qualifications

* Master's Degree, PhD, PharmD, or M.D. with a strong clinical research background, or clinical trial/drug development experiences at various phases of development (Phase 1-3)
* Industry experience (6+ years) in clinical R&D preferably focused on neuropsychiatric disease, or equivalent
* Working knowledge of the concepts of global clinical development, clinical research, and clinical trial design, including biostatistics, dose selection, clinical endpoint validation, product profiles and target labels, and global regulatory agency processes
* Professional history of solving problems and navigating uncertainty while exhibiting superior judgement and a balanced, realistic understanding of competing issues and priorities
* Professional history that includes a track record of outstanding leadership and collaboration skill in working within a matrix environment
* Professional history that includes a successful track record of preparing and conveying complex medical/clinical concepts in both written and oral communication
* Professional history that includes a track record of working within mid- to late-stage clinical programs (and/or within a contract research organization) through major project milestones, including interactions with health authorities
* Professional history that demonstrates scientific and analytic ability, ability to think strategically and tactically, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
* Professional history that demonstrates the ability to initiate and cultivate productive relationships with investigators, scientists, and patient advocates

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.