Biogen Idec Work Values

Daily Duties at Biogen Idec:

Regulatory Team Leader for the following development programs: • Regulatory Team Leader responsible for filing a Marketing Authorization Application (MAA) in Europe for a biological product using the Centralized Procedure. Coordinated clinical and CMC regulatory teams to ensure consistent messaging throughout the dossier, maintaining timelines, and managing authors. Responsible for communicating risks and risk mitigation strategies to senior management. Responsible for EU national regulatory agency meetings to assess the likelihood of filing success and rapporteur selection. (this project resulted from due diligence of the biologic) • Regulatory Team Leader for Phase III small molecule program in psoriasis and multiple sclerosis in both US and Europe. Responsible for preparing European regulatory strategy for MRP, including meetings with the Reference Member State and Concerned Member States, establishing regulatory strategy for MAA content, and working with European co-development partners to ensure consistency in regulatory strategy. In the US, responsible for regulatory activities and strategy for initiating Phase III clinical trials, including End-of-Phase II meeting with FDA and IND filings. (this project was the result of an extensive global due diligence program) • Regulatory Team Leader for IDEC Oncology Collaboration, prior to the merger with IDEC. This collaboration included the joint development of a portfolio of oncology products including a cytokine gene therapy product and monoclonal antibodies for multiple oncology indications (glioma, pleural metastases, liver metastases from colorectal cancer, and solid tumors). Responsible for program related regulatory strategy, including pre-clinical, clinical, and CMC, to support global product development. • Regulatory Team Leader for gene therapy program. Primary FDA and NIH contact responsible for regulatory filings, including FDA briefing documents, IND and 2 NIH RAC submissions (glioma and prostate cancer), clinical and CMC amendments (including a major CMC amendment for a change in manufacturer and cell line), and safety reports. Responsible for managing regulatory related manufacturing, product development, pre-clinical and clinical issues specifically related to the development of gene therapy products. Lead numerous FDA meetings. • Regulatory Team Leader for ICOS Co-Development Partnership, developing a small molecule for the treatment of psoriasis. Primary FDA contact, lead face-to-face pre-IND meeting, coordinated pre-IND activities and IND filing. Participated on joint development project team, and CMC and clinical working teams. Provided clinical and CMC regulatory development strategy for the initiation of worldwide Phase IIb program. (this development partnership was the result of an extensive due diligence project) • Provided regulatory guidance for early stage biologics and small molecule projects in oncology and autoimmune disease indications, including the toxicology IND-enabling requirements and CMC product development requirements necessary for transitioning products from research into early clinical development. Responsible for pre-IND and IND activities and submissions. Participated on research and CMC product development teams. Filed 2 US IND submissions in psoriatic arthritis and Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) for previously approved biologics. • Collaborated with Business Development group on due diligence efforts for in-licensing, partnering, and out-licensing initiatives. Conducted 11 regulatory due diligence assessments for small molecules and biologics in the areas of oncology, multiple sclerosis, and psoriasis. Prior to the IDEC collaboration, led the regulatory due diligence for the oncology product portfolio. Extensive involvement in partnering discussions, including potential development of a venture funded NewCo, and the regulatory due diligence that ultimately resulted in the IDEC Oncology Collaboration. Established the regulatory strategy for the Biogen Oncology Business Unit, including fast track and accelerated approval development and registration strategies. • Regulatory liaison for BIO and Massachusetts Biotechnology Council (MBC). Active participant on the BIO Regulatory Affairs Committee (RAC) participated in committee meetings, CDER/CBER liaison meetings, and subcommittees involved in drafting industry responses to FDA draft guidance documents.

What they like about Biogen Idec:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing

Skills

These are some of the questions we asked our climbers about their experiences with Biogen Idec: