Summary: The Director of Infrastructure and Cloud is a strategic role responsible for planning, implementing, and managing all IT infrastructure and cloud operations to enable business capabilities and services across the enterprise. This role will oversee all enterprise infrastructure and cloud services, including on-prem and cloud, SaaS services, identity management, network and wireless...

Job Description The Senior Director, Information Technology (IT) Systems will collaborate with the VP, IT to provide the strategic framework for validation, management, and support of GxP-regulated systems and implement against the strategy in collaboration with stakeholders. The Senior Director, IT Systems will work with Quality, R&D, Clinical, and Compliance stakeholders to map out short...

Job Description: Position: Senior Director, PV Operations Department: Pharmacovigilance Reports to: VP Pharmacovigilance Location: Boston or Hybrid Summary: The Senior Director Pharmacovigilance (PV) Operations will be accountable for the overall PV operations, which includes all aspects of adverse event collection, processing and reporting from all sources, vendor management, and...

Senior Regulatory Consultant Job Description In this role, you will serve as a regulatory advisor to our clients for our development stage engagements. You will lead regulatory teams and activities focusing on pre-IND and late-stage guidance and serve in an executive role with clients. Characteristic Duties: Act as an on-demand Regulatory Executive to multiple sponsor companies Lead...

Sr Manager/Associate Director of Technical Operations, Drug Substance Position Description The Sr Manager/Associate Director of Technical Operations, Drug Substance ensures the drug substance supply for approved small molecule therapy. This role collaborates closely with QA, regulatory, and compliance teams, supporting commercial drug supply and is involved in supplying drug substance to a...

Position: Contracts Manager Summary: Seeking an experienced and detail-oriented Contracts Manager to join our dynamic team. As a Contracts Manager, you will play a pivotal role in overseeing and managing contractual agreements, negotiations, and compliance processes. Your expertise will contribute to the successful execution of critical business relationships, ensuring legal and financial...

Position: Associate Director/Director Upstream Process Development & Technical Operations Summary: The Associate Director/Director Upstream Process Development and Technical Operations will be directly responsible for the process development and technical manufacturing elements of biologics drug substance programs. This highly visible position will report to the Senior Director of Technical...

Senior Accountant Looking for a full time Senior Accountant to join a 9-person Accounting Team. This position will report to the Senior Controller and will focus on various month end close tasks and Accounting Team projects. This position will be responsible for ensuring accurate and timely financial reporting in compliance with US GAAP standards. Responsibilities Assist in the month end...