Talent.com
Director, CMC Asset Lead (Rare Disease)

Director, CMC Asset Lead (Rare Disease)

BiogenCambridge, MA, US
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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.

    Crear una alerta de empleo para esta búsqueda

    Director Rare Disease • Cambridge, MA, US

    Ofertas relacionadas
    • Oferta promocionada
    Director, Commercialized Asset Planning Lead

    Director, Commercialized Asset Planning Lead

    Ionis BrandBoston, MA, US
    A tiempo completo
    Director, Commercialized Asset Planning Lead.Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decade...Mostrar másÚltima actualización: hace 21 días
    • Oferta promocionada
    CMC Lead, Small Molecules

    CMC Lead, Small Molecules

    Takeda PharmaceuticalsBoston, MA, US
    A tiempo completo
    As a CMC Lead, Small Molecules (Associate Director), you will be responsible for leading and managing the engineering operations within the organization. You will focus on ensuring standards of qual...Mostrar másÚltima actualización: hace 19 días
    • Oferta promocionada
    Director, Commercial Drug Products & Life Cycle Management

    Director, Commercial Drug Products & Life Cycle Management

    AmgenCambridge, MA, US
    A tiempo completo
    Director, Commercial Drug Products & Life Cycle Management.Join Amgen's Mission of Serving Patients.At Amgen, if you feel like you're part of something bigger, it's because you are.Our shared missi...Mostrar másÚltima actualización: hace 9 días
    • Oferta promocionada
    Market Access Strategy, T1D Director

    Market Access Strategy, T1D Director

    Vertex PharmaceuticalsBoston, MA, United States
    A tiempo completo
    Job Description • • • •Director, Market Access Strategy, T1D • • • •Location • • : Boston, MA (3 days onsite, 2 days remote weekly) • •General Summary : • •Vertex currently operates at the forefront of rare diseas...Mostrar másÚltima actualización: hace 4 días
    • Oferta promocionada
    Global Medical Director - Oncology

    Global Medical Director - Oncology

    SanofiCambridge, MA, US
    A tiempo completo
    Global Medical Director Oncology.In order to pursue Sanofi's purpose of "Chasing the miracles of science to improve people's lives", Specialty Care Medical Affairs have a vision to be the leaders i...Mostrar másÚltima actualización: hace 1 día
    • Oferta promocionada
    Director, Commercial Manufacturing

    Director, Commercial Manufacturing

    Zevra Therapeutics, Inc.Boston, MA, United States
    A tiempo completo
    We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, pat...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Director, Clinical Portfolio Technology

    Senior Director, Clinical Portfolio Technology

    Alnylam PharmaceuticalsCambridge, MA, United States
    A tiempo completo
    Alnylam seeks a strategic technology leader to drive the strategy, delivery, and governance of platforms supporting Clinical Delivery, Portfolio Management, and Data Science, Statistics, & Epidemio...Mostrar másÚltima actualización: hace 1 día
    • Oferta promocionada
    Senior Director, Global Commercial Strategy – CF Pipeline Lead

    Senior Director, Global Commercial Strategy – CF Pipeline Lead

    Vertex Pharmaceuticals (San Diego) LLCBoston, MA, United States
    A tiempo completo
    Job Description • •Vertex operates at the forefront of scientific innovation.It has seven approved medicines : five that treat the underlying cause of cystic fibrosis (“CF”), a life-threatening geneti...Mostrar másÚltima actualización: hace 16 días
    • Oferta promocionada
    Associate Director / Director, Regulatory CMC

    Associate Director / Director, Regulatory CMC

    CRISPR TherapeuticsBoston, MA, United States
    A tiempo completo
    This position is a key leadership role for the development of the In Vivo franchise at CRISPR.Reporting to the Head of Regulatory Affairs CMC, you will work closely with cross-functional teams and ...Mostrar másÚltima actualización: hace 10 días
    • Oferta promocionada
    Market Access Strategy, T1D Director

    Market Access Strategy, T1D Director

    Vertex Pharmaceuticals IncorporatedBoston, MA, United States
    A tiempo completo
    Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF), Sickle C...Mostrar másÚltima actualización: hace 4 días
    • Oferta promocionada
    Senior Director, CMC Program Lead

    Senior Director, CMC Program Lead

    Scholar RockCambridge, MA, US
    A tiempo completo
    Senior Director, CMC Program Lead.The Senior Director, CMC Program Lead will serve as a strategic and operational leader, overseeing the execution of Scholar Rock's CMC development and manufacturin...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Medical Director

    Medical Director

    AVEO PharmaceuticalsBoston, MA, United States
    A tiempo completo
    Senior Vice President, Head of Clinical Development.AVEO Oncology is seeking a highly skilled and experienced Medical Director to join our dynamic team. The successful candidate will have a strong b...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    CMC Asset Lead

    CMC Asset Lead

    BiogenCambridge, MA, US
    A tiempo completo
    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 provid...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Medical Director in Cambridge, MA

    Medical Director in Cambridge, MA

    TeamHealth CorporateCambridge, MA, United States
    A tiempo completo
    Are you an anesthesiologist ready to take your career to new heights? As a facility medical director with TeamHealth, you'll lead a team of dedicated professionals who share your commitment to exce...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Director, Global Launch Lead empasiprubart in MMN

    Senior Director, Global Launch Lead empasiprubart in MMN

    argenxBoston, MA, US
    A tiempo completo
    Senior Director, Global Launch Lead.Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. Argenx is preparing for multi-dimensional expansion t...Mostrar másÚltima actualización: hace 13 días
    • Oferta promocionada
    Senior Medical Director, Clinical Development

    Senior Medical Director, Clinical Development

    Deciphera PharmaceuticalsWaltham, MA, US
    A tiempo completo
    We are seeking a dynamic and strategic.Senior Medical Director, Clinical Development.This critical leadership role will provide clinical direction across one or more programs in early and / or late-s...Mostrar másÚltima actualización: hace 21 días
    • Oferta promocionada
    Senior Director / Executive Medical Director, Global Clinical Lead

    Senior Director / Executive Medical Director, Global Clinical Lead

    Wave Life SciencesLexington, MA, US
    A tiempo completo
    Focus on the core content of the job post, removing any extra metadata, navigation mentions, and redundant headers.Keep the formatting beautiful and clean, ensuring high signal to noise ratio.Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Director, Clinical Program Compound Operation Lead

    Senior Director, Clinical Program Compound Operation Lead

    SigmaNorth Billerica, MA, US
    A tiempo completo
    The Compound Operational Lead (COL) is a global position within Global Development Operations that provides oversight and operational leadership for the planning and execution of clinical programs....Mostrar másÚltima actualización: hace más de 30 días