Do you have a significant experience in project management defining strategy for different project development phase and therapeutic areas?
Did you already lead cross functional teams in a global matrix environment?
Are you known for your resilience and optimism, and looking for your next challenge?
In this case, you should have a look at this opportunity!
Our client, an international biotechnology industry based in the Geneva area, is looking for a:
Director Global Project Lead
(temporary contract - from September 2021 to March 2022)
Lead cross-functional development teams, define the program strategy in alignment with relevant governance bodies and supervise Project Managers in the execution of global development programs for the Biosimilar Unit. Lead the definition and implementation of the Target Product Profile with relevant functions and the overall product development strategy (integrated Development Plan, iDP).
Lead the Global Program Leadership activities for several projects ensuring high standards of performance of the project teams and its individual members. By its central role for the programs, the person in charge is expected to make a critical contribution to the success of the Unit.
Assume accountability for the delivery of either early or late stage projects from strategic perspective. Drive and lead the project teams from a strategic stand point. Provide critical cross-functional input into project strategy and ensure cohesion of the early or late stage project activities. Lead Project strategic initiatives.
As member of the leadership team of the Program Leadership and Managemnet function, contribute to the strategy of the function.
- Act as deputy to Head of Program Leadership and Management when senior leadership input/attendance at meetings is required.
Define and get approved the strategy of either early or late stage portfolio in alignment with relevant government bodies. Active contribution in portfolio decisions.
Accountable for driving the valuation of early or late stage projects, including external opportunities, leading the creation of assumptions and the alignment for project evaluation.
Set priorities for either early or late stage project activities, escalate resource conflicts and contribute to resolution. Align resources needs and prioritization with government bodies.
Drive definition of robust and focused Target Product Profiles (TPP) together with commercial function, generate comprehensive and consistent strategic development plans (iDP) with program team, drive definition of regulatory dossier strategy plans together with regulatory function. Contribute to the creation of storyline and key messages for the regulatory submissions (dossier and consultations); work with the regulatory lead to develop a global submission strategy; align the full development team to agreed strategy.
Remain abreast of new developments in the biosimilar field, and contribute to building business insight and knowledge within the Biosimilars team
Ensure optimal steering of processes, and contribute to improvement of systems (processes, tools).
- Leading the development team, define the program strategy and driving the implementation of a global development program for the biosimilar unit with substantial impact on the success of the program and therefore the success of the whole unit.
Drive development of a Target Product Profile (TPP).
Based on the TPP, lead definition of development strategy, summarized in an iDP and ensure governance committee approval.
Lead the development and the approval of a QTTP as quality target for the product.
Lead Biosimilar Program Team (s) to ensure accountability and performance of the team and each function representative.
Make necessary decisions for the product within the frame of the approved strategy or escalate to the governance committee if appropriate.
Communicate transparently risk (changes in the risk profile), mitigations and options to ensure alignment of the Biosimilar unit behind the product strategy.
Cooperation with internal and external stakeholders:
All members of the biosimilars governance committees and functions represented in the Project Team.
Head of functions within biosimilar unit.
R&D, Controlling, Finance, Portfolio, Manufacturing.
- Regulatory agencies; CROs, CMO and licensing partners.
- Advanced scientific/business degree with 10+ years' experience in biopharma/biotech industry.
Competencies and skills:
Excellent organizational skills a must.
Strategic orientation, leadership and management competencies (problem solving, influencing and decision making, driving teams to deliverables, ...)
Entrepreneurial spirit and action/results driven.
Ability to critically evaluate scientific data obtained at different stages of development.
Excellent communication skills, both oral and written.
Strong interpersonal, networking and relationship skills required.
Dynamic, energetic and positive mindset.
Must be proficient with Microsoft Office programs and project management tools & concepts.
- Seniority in Program Leadership with minimum 5 years on complex projects having dealt with different project development phase and therapeutic areas.
- Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development.
- Experienced working in the field of biosimilars or biologics.
- Advanced knowledge of project management principles.
if you recognize yourself in this ad, don't wait any longer and apply now!
Randstad (Schweiz) AG