Global Program Head

Posted 2 years ago

Key responsibilities

  • Guide innovation, provide drug development expertise and strategic leadership to the programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercial disciplines
  • Define the vision, overall development strategy and operational implementation for the assigned technology innovation programs based on regulatory and market requirements to obtain drug approval and maximize the out-licensing value of the programs
  • Identify Improved Therapeutic Benefits opportunities to expand product Life Cycle including product differentiation strategy.
  • Anticipate internal and external drivers of changes to strategy, and respond by making rapid, well-judged adjustments to the programs roadmap
  • Identify potential issues and risks; develop, align and implement mitigation plans in a transparent and timely manner
  • Drive proactive scenario planning and risk taking paths across the project teams
  • Develop team effectiveness and lead high performing project teams to achieve superior results
  • Jointly with the Global Line Functions and the Project Managers, align on staffing of Project Teams. Identify, resolve and escalate resource issues
  • Set goals, actively coach and contribute to the performance appraisal of the project team members in close partnership with the line-functions
  • Oversee execution of the Program strategy across all functions and sub–teams
  • Drive project operations in close partnership with the Project Managers
  • Communicate the strategy to the global project teams and functions, and ensure that the agreed strategy is reflected in the operational activities
  • Drive and steer the implementation of the Program strategy in close collaboration with the relevant functions within agreed timelines, budgets and resources
  • Define and implement clear measurable goals for program execution
  • Propose and manage, with the support of the Project Managers, the management of internal and external budgets related to the programs
  • Ensure adherence to quality and compliance
  • Represent the Programs internally and externally with objective advocacy of their potential and transparent disclosure of their risks
  • Secure internal alignment on vision and strategy with governance bodies, board members and across functions and departments
  • Develop and maintain external communication strategy around the Programs targeting different stakeholders such as patients and potential out-licensing partners
  • Shape the external environment to strengthen the company position related to the program by developing strong evidence and trust-based relationships with key stakeholders (regulators, KOLs, patient groups, scientific societies)
  • Maintain and develop a positive organizational culture, by promoting the values of the focus on patients, science, collaboration and people Alliance management leader for in-licensed, out- licensed or co-development projects.
  • Member of new opportunity evaluation due diligence team.

Your profile:

  • Scientific background, PhD and/or MD preferred
  • At least 7 years of experience in pharmaceutical drug development in areas such as pharmacology, clinical studies, CMC, ADME, Toxicology or translational medicine
  • Extensive end-to-end global drug development experience in Oncology, endocrinology, infectious and rare disease or bio-betters/biosimilars product development. Additional therapeutic areas, and/or proprietary drug development experience is a plus
  • At least 5 years of experience in Project Leadership from preclinical stage up to registration and launch or out license. Track record leading Life Cycle management project including formulation improvement, product delivery or combination opportunities improvement, including medical devices.
  • Experience in out-licensing and external opportunity assessment (development and business). Exposure to regulatory, manufacturing, pricing requirements/ challenges for development, registration and commercialization in US, EU and RoW
  • Solid business acumen and competitive landscape understanding in the relevant therapy area
  • Integrated strategic thinker across drug development functions with ability to scope and challenge their plans and deliverables
  • Understanding of multiple drug development disciplines (e.g. translational medicine, regulatory, pre-clinical pharmacology, CMC, clinical development and operations, market access, marketing, business development, project management)
  • Excellent strategic agility, willingness to experiment and take smart risks
  • Insight into and understanding of principles related to evaluating business deal structures including commercial collaborations, in-licensing and out-licensing deals, and divestitures
  • Experience in budgetary management and decision-making
  • Project management experience, mastery of risk management and deep understanding of the requirements for successful commercialization of biosimilars Proven ability to successfully deliver projects in a fast-paced environment with competing priorities under tight deadlines
  • Decisiveness, ability to lead cross-functional teams, and to drive results collaboratively in a matrixed team environment
  • Excellent communication and presentation skills, ability to interact at all levels of the organization
  • Strong ability to influence and align stakeholders at all levels and establish collaborative relationships with the external scientific and business community.
  • Outstanding scientific and analytical skills combined with superior problem-solving skills
  • Proven ability to manage, mentor and coach experts from different functions
  • Ability to communicate seamlessly with scientific and business stakeholders, to negotiate timelines, resources and to foster effective collaboration to deliver results

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