Director, Clinical Science

Alnylam Pharmaceuticals•Cambridge, MA

2d•Hybrid

About The Position

The Director, Clinical Science is a member of the global clinical development team and works closely with clinical research colleagues—including the medical lead, medical monitor, statistician, medical safety director, safety manager, and clinical pharmacologist—to support investigations that deliver development strategies for therapeutic compounds. The role contributes to trial development strategy, study design, protocol concept sheets and protocol development, clinical study execution, and key regulatory documents. It also contributes to clinical filing activities for new drug applications, including preparing or editing regulatory documents and participating in responses to Regulatory Agency questions. The Director serves as a clinical science expert for assigned studies and independently leads the clinical execution of one or more studies, potentially with accountability for program-level clinical deliverables. The role may include managerial responsibility for clinical colleagues or contingent workers, including supervision, mentoring, or development of others. The position also contributes to continuous improvement and innovative approaches to improve clinical trial execution.

Requirements

Minimum of a college degree in life sciences or a nursing degree.
At least 10 years of experience in the pharmaceutical or biotechnology industry.
Scientific and analytical ability.
Ability to think strategically and tactically.
Interest in applied clinical research.
Ability to work effectively in multifunctional and multinational teams.
Ability to multitask and prioritize.
Proven experience developing effective relationships with key investigators.
Experience leading a team in a matrix setting.

Nice To Haves

Advanced degree, such as a PhD, PharmD, or MS.
Experience in cardiovascular disease and large outcome trials.
Proven track record of successfully executing multiple proof-of-concept and pivotal trials.
Experience with (s)NDA submissions and Health Authority interactions.

Responsibilities

Maintain current scientific and clinical knowledge in assigned therapeutic and disease areas and serve as the clinical science expert for assigned studies.
Independently lead clinical execution of one or more studies and potentially be accountable for program-level clinical deliverables.
Provide input to protocol design documents and lead development of protocols, amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Represent clinical science on internal protocol review committees and partner with or support the Clinical Research Lead on study and disease-area strategy; participate in protocol-related KOL and Health Authority interactions as needed.
Ensure development of Study Informed Consent Documents and responses to requests from external stakeholders, including Health Authorities and Independent Ethics Committees.
Provide clinical guidance for the Statistical Analysis Plan and Tables, Listings, and Figures.
Guide development of clinical data collection strategies, instruments, and data review plans, ensuring alignment with the protocol and SAP, optimized data collection, and clinical data review best practices.
Set the clinical data review strategy; lead review of emerging clinical data and trends; review and query data; present data to stakeholders; support resolution of data issues with site-facing colleagues; and ensure clinical queries are addressed in support of database lock.
Collaborate with Medical Safety and Pharmacovigilance on Safety Review and Safety Narrative Plans; review safety data, update clinical documents in response to emerging safety information, lead clinical safety discussions at Safety Review Team meetings with medically qualified individuals, and review safety narratives.
Guide development of the Risk Management Plan, ensure clinical activities comply with the approved plan, and work with stakeholders to develop and implement risk mitigations.
Collaborate with the medical monitor on establishing and managing External Data Monitoring Committees and Adjudication Committees, including charters, data provision and presentation, and documentation and dissemination of recommendations.
Develop site selection criteria, provide clinical input on site selection, and ensure protocol training is delivered to site-facing colleagues.
Participate in investigator meeting planning and develop and deliver protocol training, including ongoing training in response to protocol amendments, emerging data issues, and quality events.
Serve as the primary clinical point of contact for investigators and the study team on clinical protocol questions; manage development, delivery, documentation, and curation of clinical responses, such as FAQs.
Ensure protocol deviation sub-categories are established, deviations identified during clinical data review are reported and appropriately managed and reconciled, and deviation trends are reviewed.
Ensure TMF compliance for clinical documents.
Provide clinical input to and review the Clinical Study Report.
Ensure disclosure of safety and efficacy data and trial conclusions; contribute to primary publications as appropriate.
Provide clinical support for audits and inspections, including responding to and addressing findings.
Contribute to clinical sections of regulatory filings as needed, including Briefing Documents, Pediatric Investigational Plans, Investigator Brochures, IND/NDA Annual Reports, Periodic Safety Update Reports, and responses to Health Authority requests.
Contribute to continuous improvement, process enhancement, and innovative approaches to maximize clinical trial execution effectiveness.
As applicable, supervise, mentor, or develop clinical colleagues or contingent workers.