The Director of Global Patient Safety and Risk Management role is to provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product. This is a highly visible role that will interface across all levels and functional areas and will need to partner closely with the clinical development and commercial teams.  The exceptional candidate that we seek will have an excellent medical judgment, strong analytical skills, proactive approach in drug safety and a flexible, hands-on nature with a high sense of urgency.

Summary of Key Responsibilities

•    Provide guidance for the development of worldwide pharmacovigilance strategies within Alnylam’s goals, including the support to Safety Operations for establishing and maintaining policies and procedures for the Clinical Drug Safety Department.
•    Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the lifecycle of a defined portfolio of products.
•    Guide the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.
•    Be accountable for timely completion of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
•    Lead multidisciplinary teams (e. g. Safety Risk Management Teams) regarding safety relevant topics and escalate all relevant safety matters to the appropriate decision-making level with proposals for solutions based on analysis of the available information.
•    Serve as the safety expert providing strategic input to key stake holders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class.  Be the subject matter expert for relevant safety discussions with regulatory agencies and other significant external bodies.
•    Be the author and accountable content owner for all safety relevant content or documents during clinical development (e.g. DSUR, Development Risk Management Plans, Safety Analysis Plans) and post approval (e.g. PSUR, RMPs, medical expert statements and answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters and company statements.
•    Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.

Qualifications

Alnylam prides itself on its entrepreneurial, fast-paced environment where success is rapidly rewarded.  There is a strong pipeline, significant resources, and every intention of continuing the phenomenal rate of success and growth.  This position offers an opportunity to have tremendous impact on the growth of the company.  The culture values hard-work, creativity, flexibility, a sense of humor and a hands-on, problem-solving attitude.

The ideal candidate will have the following mix of personal and professional characteristics:

•    Medical Degree with a minimum of 3 years of medical practice is required.
•    Sound clinical acumen and a wide range of therapeutic area knowledge.
•    2 years of pharmaceutical industry experience as a product/program lead within pharmacovigilance and/or clinical research/clinical safety/clinical development strongly preferred.
•    Experience in clinical development is a plus.
•    Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework.
•    Ability to synthesize and analyze safety data from various sources.  Proficiency in problem-solving within a highly complex environment.
•    Strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
•    Excellent networking and relationship building skills for successful cooperation with internal and external customers.
•    Expertise in international regulations governing drug safety.  Experience in managing compliance or audits. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred.
•    Excellent interpersonal and decision-making skills. Strong influencing skills with the ability to quickly earn credibility across other functional areas.
•    Ability to work in fast-paced environment with rapidly approaching timelines is important