Affibody is a clinical stage Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
The company operates a focused innovative medicines model and currently has three clinical proprietary programs. The first two are therapeutic programs that target psoriasis, and B-cell driven autoimmune diseases. The third program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.
In addition to its portfolio of innovative drug projects the company offers the half-life extension technology, Albumod™, for outlicensing.
Affibody has ongoing commercial relationships with several companies such as AbClon, Alexion, Biotest, Daewoong, Daiichi Sankyo, GE Healthcare, and Swedish Orphan Biovitrum.
Affibody is currently offering a very exciting possibility to join their journey, as Global Program Director (GPD).
The Global Program Director is the strategic leader for the global development program ABY-035, responsible for the full life cycle of the program.
The GPD is responsible for management and delivery of the integrated development plan, encompassing the strategy for the medicine across indications and ensuring alignment across strategic/operational/tactical plans, in support of the overall objectives and priorities of the program.
You will be the leader of the Project Team, a cross functional, multidisciplinary team with the assignment to deliver the overall Project Development Plan.
- Drives development of global project level goals that contribute to the overall goals of R&D
- Leads the development of an Integrated Development Plan, encompassing the overall R&D strategy for the compound and ensuring alignment between the overall product vision, strategy, and goals
- Drives decision point planning and the associated deliverables across all functions of the team and contributes to the R&D strategy planning process for the project
- Leads decision analysis with the team including development and assessment of outcome scenarios and alternative development options, robust go/no go decision criteria, probability of technical and regulatory success, value, and investment implications
- Proactively recommends and drives the operational plan and resource adjustments to improve productivity and return for the program.
- Drives development of the global project level goals that contribute to the overall objectives for the R&D portfolio. Monitors and reports on progress of the program goals
- Leads generation and alignment of a Global Integrated Development Plan across functional lines
- Drives milestone decision point planning and associated deliverables across functions to achieve the overall program objectives. Clearly defines the critical path and generates clear decision criteria for the project
- Leads the process for evaluation of alternative development options to operationally deliver plan. Influences and drives development of solutions, criteria, and implications
- Leads the Project team to ‘pressure-test’ assumptions and integrate planning across development into the overall project plan, (e.g. Medical Sciences, Regulatory, Clinical Operations, Biostatistics, Technical Operations, Commercial, Global Medical Affairs (GMA), Toxicology, Research functions, etc.). Defines the interdependent deliverables and ensures that quality, risk, cost, time are managed within the overall pproved plan to drive delivery of project milestones and objectives on time and on budget.
- Manages an integrated project budget and resource plan and is responsible for the overall project timelines
Project Resource Management
- Leads and negotiates project-level budgets and resource plans on behalf of the team. Proactively manages the project budget and resource demand including investment buy-ups/buy-downs in partnership with the Team Leader, Finance, and Functional lines.
- Manages against an approved budget and resources for the project to ensure it is in alignment with the overall R&D budget.
- Engages robust project management skills to drive projects to key decision points and milestones. Proactive management of the critical path, operational feasibility of strategic plans, active identification and management of project risk, and alignment of operational execution.
Project Risk Analysis and Management
- Leads the team in the preparation, implementation and maintenance of integrated project level risk management plans including risk identification, assessment, and action plan with negotiated trigger criteria, resource requirements, and impact.
- Leads the assessment of project risk (technical and regulatory success and operational) in collaboration with the Team Lead, R&D Functional Lines, Technical Operations, Commercial, Legal, and other functions.
- Leads the team to identify contingency and risk mitigation strategies for project/program level plans and negotiates the preferred team option to achieve this most rapidly for the lowest cost while maintaining acceptable quality.
Information & Communication Management
- Responsible for development and management of the communication plan for the program, including stakeholder management.
- Defines and aligns project messages and major communications (internal and external) with the RMT ( leadership team Affibody). Responsible for ensuring effective, accurate and timely communication of project information in order to facilitate development of action options and team recommendations to governance.
- Responsible for ensuring effective, accurate and timely communication of project information.
- Effectively communicates project issues and opportunities.
- Identifies team performance issues in order to recommend and develop appropriate corrective actions.
-Experience in managing and leading multiple complex projects/programs of relevant experiences within the biopharmaceutical industry.
-Demonstrated success in leading and negotiating in a matrix-based organization.
-Empowering leader who engages others to take ownership of projects and drives decisions that achieve shared goals through teamwork.
-Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective.
-Strong track record in executing effective project management in cross-functional drug development teams or clinical, regulatory, medical functions, pharmaceutical sciences/technical operations in the biopharmaceutical industry.
-Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality, and risk management to teams.
-Fluently in English, written and oral
-Energetic, entrepreneurial, teamplayer
-Must thrive in creative and growing organisation
The position is office based at the Affibody HQ in Stockholm.
To apply, please send your CV and letter to email@example.com as soon as possible!
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