You will assist by leading projects related to R&D, Manufacturing and/or Clinical activities and contribute to the company’s pipeline by identifying scientific and business opportunities and aligning activities with the corporate strategy. You can anticipate collaboration and frequent communication with external stakeholders, such as academic collaborators, CROs and CMOs. In particular:

· Manage and drive priority projects by leading cross-functional project teams, which include team members from R&D, Manufacturing, Clinical, Regulatory, Quality, Supply Chain.

· Develop and consolidate the company’s pipeline by performing competitive intelligence activities and aligning activities with the corporate strategy. Keep up to date with the latest developments in the field of tumor glyco-immunology (academic and industry-driven) and integrate this knowledge into the pipeline to maintain company’s competitive advantage.

· Lean internal project management meetings such as progress and stage-gate meetings.

· Contribute to, Review and archive all project documentation, such as project inputs/outputs (e.g. TPPs, protocols, study reports, regulatory submissions) or documentation related to the management of the projects (e.g. meeting minutes, action items, risk log, issue log, change log).

· Implement good management practices, such as creating and maintaining an overarching project management plan, which integrates the various aspects of a project (e.g. scope&requirement, budget, schedule, quality, risk, team, communication, procurement, stakeholder).

· Drive and monitor critical path activities toward the achievement of milestones with clear timelines and budgets.

· Perform risk management activities and communicate to the upper management identified project risks and develop mitigation and contingency plans.

· Ensure effective communication with strategic partners such as CROs, CMOs, academic collaborators, industry/business partners and external vendors and consultants on outsourced workstreams. Interface with their team to manage expectations, ensure compliance with quality standards and timelines.

· Assist in intergating the GMP, GCP and GLP to the various activities to meet quality and regulatory expectations.

· Participate in the selection process of CROs and CMOs.

· Ensure compliance with company policies and procedures, as well as applicable laws and regulations.

· Foster a culture of ownership and accountability internally and externally.

 

QUALIFICATIONS, EXPERIENCE & SKILLS

RES

· PhD in Chemistry or Immunology or a related field.

· 5+ years in project management within an industrial setting for product development in the field of biotechnology, pharma, IVD, or healthcare. Past experience in leading the transition of early-stage pharmaceutical research programs into development, manufacturing, and IND-enabling studies is a strong plus.

· A PMP certification is a plus.

· Solid understanding of drug development critical path. Experience with immuno-oncology project management is a plus.

· Demonstrated experience in identifying, planning, executing and monitoring activities in a regulated and stage-gate environment.

· Excellent communication and interpersonal skills, with the ability to work collaboratively with internal and external cross-functional teams.

· Ability to work independently and as part of a product development team.

· Strong organizational skills and attention to detail with the goal in mind.

· A track record of managing external strategic partners.

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