Director, CMC Asset Lead (Rare Disease)

Biogen Idec • Cambridge, MA

80d • $200,000 - $275,000 • Hybrid

About The Position

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership across PO&T's line functions for an asset. The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for the commercial program. This PO&T Asset Lead role is specifically responsible for leading early and late-stage Rare assets through development and commercialization. This is a hybrid role that could be based in Cambridge, MA or RTP, North Carolina.

Requirements

• Bachelor's degree and a minimum of 12 years of relevant experience with a focus on matrix management.
• Advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline.
• Track record of effective matrix leadership experience in the setting of program teams across the full product life cycle, e.g., (CMC) PO&T line functions sub-teams or other cross-functional teams operating in a matrix environment ideally across an organization.
• Experience with CMC, supply chain, or LCM development extending from IND to NDA/BLA and global launch including a solid understanding of global registration processes.
• Technical expertise in a relevant biopharmaceutical development discipline.
• Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory).
• Excellent strategic, political, organizational, and relationship development skills.
• Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
• Excellent communication, negotiation, problem solving and decision-making abilities.
• Demonstrated ability to identify critical program risks and develop mitigation plans - strategic or tactical to mitigate risk, costs, and reputation of Biogen.

Responsibilities

• Serve as the PO&T 'asset owner' with accountability for delivering a 5-year PO&T Asset Strategy, maintenance of an 18-month rolling Tactical Plan, monitoring key program risks and development of risk mitigation plans.
• Lead the cross-functional PO&T Asset Team (i.e., including representatives from each PO&T Line Function) in the development of and delivery on the PO&T Asset Strategy & Tactical Plan.
• Serve as PO&T's representative on the R&D Program teams and PDC teams; acts as an influencer and liaison between R&D, Commercial and PO&T in support of asset(s).
• Proactively manage conflicts with the Asset Strategy (e.g., driven by other Assets and/or Line Function priorities) in consultation with the PO&T Governance Committee.
• Ensure alignment and accountability of PO&T Line Functions for providing support for their needs balanced with the needs of the Asset Strategy.
• Monitor asset-related impacts on the P&L (e.g., COGS, E&O, OPEX) and collaborate with the PO&T Line Functions to develop tactics to improve them.
• Develop business cases for key Asset initiatives and secure management endorsement at the PO&T Governance Committee.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees