Associate Director, Clinical Science

Overview The Associate Director (AD), Clinical Science will be a member of the global clinical development team, working closely with other members of the clinical research group (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. Under supervision, the AD, Clinical Science may assist with study design, contribute to the protocol concept sheet, support the protocol development, and collaborate on clinical study execution. Additionally, the AD may contribute to key regulatory documents, clinical filing activities that are part of new drug applications, and participate in responses to questions from Regulatory Agencies. Key Responsibilities Clinical science expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. May provide input to the protocol design document; contributes to the development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters. Ensures development of Study Informed Consent Documents and responses to external stakeholder requests (e.g., Health Authority and Independent Ethics Committee). Provides clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures. Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice. Sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Collaborates with Medical Safety and Pharmacovigilance on the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individuals; reviews safety narratives. Provides clinical input to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations. Collaborates with the medical monitor on the establishment of External Data Monitoring Committees and Adjudication Committees, including chartering, data provision and presentation of data, and documentation and dissemination of Committee recommendations, as appropriate. Provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues. Participates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to protocol amendments, emerging data issues, and quality events. Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ). In collaboration with the medical monitor, ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review. Ensures TMF compliance for clinical documents. Provides clinical input and review of the Clinical Study Report. Ensures disclosure of safety and efficacy data and trial conclusions; may contribute to primary publications. Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings. May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests). Contributes to continuous improvement and process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution. Requirements Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (PhD, PharmD, or MS) with 8+ years of experience in the pharmaceutical/biotech industry. Previous experience working on complex trials in the area of Huntington’s Disease or other movement disorders preferred. Proven track record of successfully executing multiple proof of concept and pivotal trials; NDA submission and Health Authority interactions experience is a plus. The skills required for success include scientific and analytic ability, strategic and tactical thinking, interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, and ability to multitask and prioritize. Proven experience in developing effective relationships with key investigators. Experience leading the team in a matrix setting. Pay Range $177,700.00 - $240,300.00 Benefits Overview Alnylam offers a comprehensive Total Rewards package that includes medical, dental, and vision coverage; life and disability insurance; a lifestyle reimbursement program; flexible spending and health savings accounts; a 401(k) with a generous company match; paid time off, wellness days, holidays, and company-wide recharge breaks; and generous family resources and leave. Equal Employment Opportunity Alnylam is an inclusive employer that offers equal opportunity for all individuals regardless of sex, gender identity, sexual orientation, race, ethnicity, national origin, disability, veteran status, or any other protected characteristic. Alnylam is an E-Verify Employer. #J-18808-Ljbffr