Director, CMC Asset Lead (Rare Disease)

Pharmaceutical Operations And Technology (PO&T) Division Cmc Asset Lead

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.

What You'll Do

• 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; act as an influencer and liaison between R&D, Commercial and PO&T in support on 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

Who You Are

You are a seasoned leader with in-depth experience in drug development, supply chain or manufacturing. You will be part of ADPM, and lead teams representing PO&T disciplines and maintain critical partnerships with relevant program R&D and/or product commercial leaders. You will be instrumental in leading and facilitating key aspects of the PO&T vision including Influence & Collaborations through engagement with/oversight of collaborations and interface with BD and External Innovation; Data Access and Connectivity by driving best practices for resource management/forecasting decision gates and associated knowledge management initiatives.

Qualifications

• 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.

Job Level: Management

Additional Information

The base compensation range for this role is: $200,000.00-$275,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.