- BS/BA in scientific discipline, MS or equivalent preferred
- At least 10 years related experience in a pharmaceutical/biologics/biotechnology company;
- Extensive experience managing global studies through Phase 3 in an outsourced CRO model from start-up through close-out; experience with drug development in rare genetic diseases preferred;
- Experience managing direct reports and providing performance reviews and career development guidance;
- Experience developing Data Management SOPs and standards;
- Understanding of ICH GCP as well as general knowledge of industry practices and standards;
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11;
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial data/Data Management Systems;
- Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH;
- Experience using standardized medical terminology, including MedDRA and WHODrug;
- Experience working with Medidata Rave EDC system;
- Experience working with MS Office Suite (Excel, Word and PowerPoint), familiarity with MS Project;
- Excellent written and oral communication skills;
- Highly motivated and flexible, with excellent organizational skills;
- Ability to work independently and as part of a multi-disciplinary team
- NDA/MAA submission experience preferred
The pay range below 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