|Job type||Full Time|
Would you like to help us bring new treatments to patients with skin conditions world-wide? And would you like to be a part of a growing CMC Design and Development organisation? LEO Pharma R&D is expanding the development project pipeline and increasing the number of projects going into clinical trials and we are looking for the right colleague to join us on the journey
You will be part of the newly established CMC & Device Project Management 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:
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.
About the Area
The CMC & Device Project Management t Area is a central part of the newly formed matrix organisation in the CMC Design & Development VP Area. The VP Area spans six Director Areas, working with API, formulation, analytical methods, devices and exploratory activities within combination products, biopharmaceuticals, small molecules, topicals and systemics, with a total of app. 160 dedicated colleagues.
Your new job role will be in reference to the Director CMC & Device Project Management, where you will join 5 other highly skilled, helpful and engaged CMC & Device Project Managers.
The Area is established to provide CMC and Device Project Management for clinical development candidates all the way to first launches and secure cross-organisational, strategic business support in support of LEO Pharma's R&D 2030 strategy. We will build our organization together, bringing in best practices from own experience and other organisations while we simultaneously secure support and guidance to our colleagues and stakeholders.
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 small molecules or biopharmaceuticals, and/or within combination products 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.
What we provide:
By joining CMC & Device Project Management you will have a unique opportunity for joining and forming a growing organisation and being part of managing projects in an expanding development project pipeline. You will join a newly formed unit with a positive, constructive and helpful environment with highly skilled, engaged and caring colleagues and bringing new treatment to patients suffering skin conditions world-wide.
Please contact Director Pernille C. Svane +45 31 34 76 01 for more information. We look forward to receiving your application. Send your application to us as soon as possible and no later than Sunday 30th of January 2022.