Associate Director, PV Science

Overview

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. Alnylam currently has tree commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,600 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2019 and Science Magazine’s #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

The Associate Director, PV Science is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, adhoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Alnylam products.

Summary of Key Responsibilities

• Lead with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management.  Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Knowledge of literature review supporting signal detection.
• Accountable for quality of the medical authoring of assigned product summaries and reports.
• Responsible for coordinating and developing Risk Management Plans (RMPs) for Alnylam products among multiple stakeholders.  Participate in the collection and analysis of data related to status and measurement of the effectiveness of risk management initiatives.
• Responsible to work with product physician, affiliate management and regulatory to develop and edit Safety Management Plans /ESRPs and independently bringing issues related to these documents for discussion with impacted parties.
• Work with Regulatory to ensure submission plan for regulatory documents.
• Contribute to signaling and data mining activities utilizing internal and external sources of data.
• Strong  knowledge of capabilities and limitations of various data sources.  
• Assist in the planning and evaluation of potential safety issues and quality risk assessment reports.
• Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues. 
• With oversight from product safety lead physician, responsible for analysis, collation and presentation of safety data to multi-disciplinary safety teams.
• Contributes to SOP and template development and maintenance
• Contributes to the development the development of, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.  
• Act as a subject matter expert for GPSRM processes and tools
• Responsible for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes.
• Proposes and implements innovative strategies and/or process improvements under direction of Senior members of GPSRM
• Contribute as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritisation, budget management and forecasting.
• Establish expertise with data visualization tools (eg. Empirica, Spotfire)
• Manage and support the authoring for aggregate safety reports (eg. PBRERs, DSURs) in close collaboration with medical, medical writing and operational functions
• Provide management and training for new staff on department practices and therapeutic area knowledge.
• Participates in inspection-readiness activities and inspections as required

Qualifications

Education: Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required

Experience: Prefer three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus.  Specific experience in rare diseases therapeutic area at a global level is an advantage.

Strong skills and experience in;

• Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
• Ability to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
• Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
• Knowledge of Argus, Arisg Safety Databases
• Knowledge of Signaling tools (eg. Empirica, Spotfire)
• Experience in regulatory Inspection readiness in regulatory inspections
• Established skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Strong planning, organization, written and oral communication skills
• Experience in clinical patient care a plus
• In-depth knowledge:
  • Alnylam science, disease, and understands the interdependencies of the studies within the program and the study strategy
• Working relationships with other EAs within Clinical Development, Regulatory Affairs, Nonclinical, GPSRM, and Medical Affairs
• Proficient knowledge in ICH GCP,  Drug development process and regulations
• Skilled in using Word, Excel, PowerPoint, reference management, and EDMS
• Experience in literature review for assigned products

Special Skills: Ability to represent the functional department as primary internal and external contact on contracts and delivery for services relating to drug safety risk management.  Lead cross-functional briefings and technical meetings for project stakeholders and customer representatives.  Strong negotiation skills encouraging discussion and driving decisions to desired results.  Strong analytic and scientific writing abilities. 

Job Complexity:  Involved in RMP and Aggregate Report Management. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management. 

Supervision:  Individual is expected to work independently with support from management and colleagues in GPSRM.

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.