Director, Clinical Science

The Director, Clinical Science will be a member of the global clinical development team, working closely with other members of the clinical research group within clinical development (medical lead, medical monitor, statistician, medical safety director, safety manager and clinical pharmacologist) to support investigations that deliver the development strategies for therapeutic compound(s) under development. The Director, Clinical Science contributes to the trial development strategy assisting with study design, protocol concept sheet, protocol development and clinical study execution inclusive of contribution of key regulatory documents. In addition, the Director, Clinical Science will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies. The position will report to a Senior Director, Clinical Science / Clinical Research.

Summary of Key Responsibilities:

The Director, Clinical Science will be familiar with drug development, drug mechanism of action, and regulatory requirements and will deploy this expertise in the execution of a number of key responsibilities:

Protocol Development and Trial Planning and Operational Preparation

• Working with the Medical Director(s), to create key strategic documents including clinical development plans, protocol concepts and full protocols across the 3 phases of clinical development.
• Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, and Clinical Development Plans (CDPs).
• Provide ongoing medical expertise and oversight of clinical trials across Phases 1-3 for trial conduct and safety. Provide strategic consultation and guidance to research on all decisions that have significant clinical components and implications.
• Supervise closely all major written deliverables(regulatory submissions, original articles, abstracts), and presentation materials.

• Provide essential evaluation of the development strategy to maintain a development plan that is consistent with the latest regulatory requirements, identification of challenges, and development of contingency plans to meet them
• Provide input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc),
• Set up study steering committee to establish relationships with essential opinion leaders relevant to assigned compounds and therapeutic areas, clinical development programs and key clinical studies
• Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings

• Provide protocol training, disease specific training and presentations at investigator meetings and protocol training meetings.

Trial Execution and Study Management/Study Conduct

• Oversees study protocols, reviews, and provides medical input to essential documents (study protocols, informed consent forms, project management plans, case report forms, safety management plan, data management plan, data review plan, clinical monitoring plan
• Supports development of medical monitoring plan(s) and assists with reviews of clinical data in accordance with the Medical Monitoring Plan in cooperation with Medical Monitor, Data Management and Biostatistics

• Provides input to site selection and Coordinates feasibility studies - Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection.

• Performing medical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up. Set up and management of investigator initiated clinical and/or pre-clinical trials.
• Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards.
• Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators.

• Participate with ongoing medical review of clinical data and patient profiles, assessing issues related to protocol conduct, clinical data quality, and patient enrollment
• Attend and assist with on-site visits, such as Qualification, Site Initiation, and Interim site engagement visits
• Provide medical leadership and scientific guidance to CROs and provides ongoing medical support to study team and investigators, including management of eligibility issues

Ongoing Review of Clinical Trial Data and Safety Reviews

• Lead the development of a medical data review plan, medical monitoring plan, perform ongoing medical data review, and summarize efficacy and safety data for interpretation/analysis
• Evaluate safety, pharmacology, and efficacy in ongoing and completed studies in close collaboration with medical monitor, safety, and clinical operations teams
• Safety Review: Provides medical inputs in processing of safety cases; Assesses relatedness and expectedness of the event; Reviews SAE reports and issues SAE queries in scope of medical consistency
• Review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• Liaise with investigator, Medical Monitor and Safety Manager to review AEs/SAEs on behalf of the Sponsor.

• Assist in the development and maintenance of standard documents regarding safety and medical monitoring processes and procedures including safety reports to Data Monitoring Committees.

• Participates in blinded/unblinded data review meetings and review of clinical study report

• Assist with the preparation, review and interpretation of data from ongoing studies, assessing the medical and scientific effects, and making recommendations that impact development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling
• Assist the medical director for ensuring data quality, summary, and writing of clinical study report in close collaboration with the clinical operations, biometrics, and oversight of the CRO
• Review patient profiles and study level data review; working with medical director to perform a review of data generated by data listings or statistical analyses for assigned studies and present findings at quarterly drug safety reviews as needed
• Prepare study data reviews to Management and help provide summaries of individual study results and how the results affect the compound strategy.
• Review study synopsis/protocol development and contribute to the successful design and interpretation of clinical studies.

Data Reporting and Preparation of Study Documents

• The Director, Clinical Science is responsible for analyzing and interpreting study data from an individual study and translating study level clinical data across the program of studies for a particular drug, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.

• Participate in all reviews and procedures required for database lock and review all patient narratives

• Assist with completion of clinical study reports (CSR)

Medical and Scientific Expertise / Support

• Stay abreast of guidelines, current trends and medical practice in the assigned therapeutic area, including reports and intelligence on key and critical new technologies or treatment advances
• Provide medical and scientific input to Health Economics & Outcomes Research (HEOR) studies, RWE studies and value dossiers for market access
• Assist with medical writing and publications (reviews, summaries, primary and secondary manuscripts)

Requirements

• Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (MD, PhD, PharmD or MS).
• The ideal candidate will have 8+ years in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization.
• Proven track record of successfully executing multiple proof of concept and pivotal trials: NDA submission and HA interactions experience is a plus.
• The candidate will have previous experience working on large (>4,000 patients) global, multinational cardiovascular outcomes trials.
• The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize.
• Proven experience in developing effective relationships with key investigators.
• Experience in leading the team in a matrix setting.

U.S. Pay Range

$199,800.00 - $270,300.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.