Global CMC and Device Project Manager, Small Molecules Development Projects

Ballerup, Denmark
Job Description

You will be part of the newly established CMC & Device Project Management and Business Support organisation in the CMC Design and Development VP Area in R&D, and you will work in close collaboration with colleagues across LEO Pharma, external partners, CDMOs and CROs. You will represent CMC Design and Development in Global Asset Teams and have strategic as well as tactical impact in CMC and Device aspects of the projects you are heading. The development projects can be within small molecules, biopharmaceuticals, or combination products, and for topical, oral or systemic treatment.

An overview of your primary responsibilities are:

  • Full accountability for Project Management of defined key drug candidate development projects within CMC and Device development
  • Full accountability for CMC (Chemistry, Manufacturing and Control) and (as relevant) Device activities as applicable during development and IMP production from pre-Phase 1, Development Candidate Selection to MAA/BLA and initial Launch activities including Health Authority interactions where relevant. Overall this means that you will be responsible for securing timely supply of non-clinical and clinical test material to relevant non-clinical and clinical studies and to provide corresponding documentation packages for Health Authorities, securing that the products are of appropriate quality to treat human beings during clinical development and when on the market
  • As a Global CMC & Device Project Manager you will prepare and execute the CMC and Device development strategy and plan incl. building project scenarios. You will be responsible for the cross-organisational execution of project activities and in this connection interact with internal stakeholders and external CMO/CROs and Partners
  • A Global CMC & Device Project Manager typically covers 1-2 early stage projects, 1 late stage project or a mix of early and late stage projects, depending on project complexity
  • Establishing/leading cross-functional project teams ensuring and selecting adequate competences and resources in collaboration with the line organization.
  • Establishing and executing activities according to project plans supporting the objective of the projects, with a continuous focus on value creation and optimization of time to market/ project finalization.
  • Project budgeting, resources planning and overview.
  • Project stakeholder and relationship management, often with Global Asset Team members, Global Leadership Team members and VP/Directors.
  • Ensuring that the development of product solutions follow internal processes.
  • Stage Gate reports and presentations.
  • Ensuring establishment of project plans and recommendations in support of strategic decisions to be made by the appropriate governance structure.
  • Project reporting and communication
  • Project risk management
  • Project visualization
  • Additional to product development projects, the Global CMC & Device Project Manager must, as required, provide project management / leadership for larger, organisational improvement projects with the aim of developing/improving business processes corresponding to the complexity level of product development projects

You will work across the expanding CMC Design & Development organisation as well as with internal stakeholders in Global Asset Teams, Global Regulatory Affairs, Global Clinical Operation, Global Product Supply and External Manufacturing and with CROs/C(D)MOs or Partners and be in contact with colleagues in various departments and functions. Depending on project stage and activities, interactions with Health Authorities can be expected.

Desired Skills & Experience

You hold an academic degree (usually at Masters or PhD level) in a relevant scientific discipline with a minimum of 5 years’ experience with project management in the pharmaceutical or biopharmaceutical industries.

Broad knowledge within development of primarily small molecules or biopharmaceuticals, gained from working a number of years within several relevant fields of expertise.

Good understanding of the biopharmaceutical, pharmaceutical and/or medical device value stream.

Ability to include different perspectives through professional standard knowledge of areas across functions.

Experiences with leading different types of projects and with working in a matrix organization across cultures and time zones.

Relevant formal project management education and knowledge of project management principles and practices.

Strong organisational and business understanding.

Effective facilitation skills.

Excellent communication skills - internally and externally, orally and in writing in English and preferably Danish. Speak with authority in front of any audience and in be able to have convincing dialogues with Health Authorities.

Formalised LEAN or Continuous Improvement training and certification corresponding to Green Belt will be considered an additional advantage.

Leo Pharma
New York