The Portfolio Manager (PFM) initiates, develops, and manages the product strategies for clinical projects/studies. The PFM is accountable for ensuring vaccine/product availability and readiness in the context of clinical projects/studies.
- Perform feasibility and risk assessment related to study timings, study design, availability of products, regulatory submission strategy and documentation associated, technical product development, milestones as well as logistics operations in partnership with the key stakeholders; Asset Leader (AL), the technical team and Global Regulatory Lead (GRL).
- Follow-up milestones determined in collaboration with the key stakeholders and inform them in case of issues / changes impacting the project timing.
- Provide a calculated budget covering the end-to-end supply chain activities (Vaccines, Ancillaries, Labelling/Pack, Warehouse & Distribution) aligned with the clinical design and based on quantities/products forecasted.
- In collaboration with Product Process Expert (PPE) and the technical team, define if a clinical production is specifically required for a clinical study.
- In collaboration with the analytical team and the technical team, ensure the stability plan and supply strategy of clinical products.
- Follow-up with Planner for the clinical productions, associated release and shelf-life extensions of clinical products.
- Accountable for the product flows of all vaccines (Clinical, commercial, competitor) to ensure the traceability of the products and allow to the quality release of vaccines for clinical projects/studies.
- Collaborate with the Clinical Trial Supply Manager (CTSM) on the establishment of Clinical Supply Strategy.
- Establish and clearly communicate/escalate the end-to-end supply chain development progress and anticipate issues.
- Provide clear project management leadership, and drive accountability among project team representatives.
- University degree in Life Science/Healthcare or relevant work experience in pharma/clinical environment is required.
- At least 3 years of relevant project management experience.
- Languages: English proficiency required (verbal and written), French is an asset but not required.
- Good leadership, strategic thinking, communication and advance problem-solving skills.
- Demonstrate the ability for leading initiatives with cross functional teams and implementation of recommendations.
- Ability to work within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.
- Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.
- Ability to work in multi-cultural teams; positive team spirit and interpersonal skills
- Is self-driven by successful execution of different tasks.
- High level of flexibility and sense of urgency.
- Operates with a high degree of integrity, responsibility, independence and initiative.
- Experience in clinical study, Risk Management and Management Monitoring is an asset.
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.