Senior R&D Project Manager

A leading clinical-stage biopharmaceutical company that focuses on cancer therapy is recruiting a Senior R&D Project Manager. The organisation specialises in developing medicines that seek to block tumour immune evasion and offers patients benefits that are far more advanced than current immuno-oncology treatments. Based in Cambridge, this is an exciting opportunity to join this company during a period of expansion in the US, as they have recently opened an office in Massachusetts. The role will be a perfect fit for applicants with significant experience in project management, in particular early clinical stage projects and biologics drug development.

The Project Manager will manage the delivery of all aspects of clinical projects, working closely with key clinical, translation, manufacturing & supply, medical and research functions, and third-party providers.

Job Responsibilities:

• Project managing early clinical programmes.
• Project managing the delivery of robust clinical and translational packages for the company's bispecific antibodies in close collaboration with cross functional team members and in particular, clinical operations.
• Being responsible for Target Product Profiles (TPP) and strategic development plans.
• Working with the CMC team, clinical operations, and translational science team to project manage clinical activities for Phase I and II clinical studies.
• Working with the team to develop and translate project strategy into operational plans and budget that meets internal and external stakeholder requirements.
• Managing project team interaction with key collaborators and ensuring effective communication to maximise value of collaboration.
• Monitoring all project activities at external contractors and ensure appropriate timelines, budget and quality standards are met.
• Managing project budgets (forecast and active tracking) and maintaining active project plans (using MS Project), risk registers, and gap analysis.
• Contributing to the preparation of regulatory briefing documents and preclinical/clinical elements of regulatory submission documents.

Skills and Requirements:

• Project managing early clinical programmes including;
• Project managing the delivery of robust clinical and translational packages for the company's bispecific antibodies in close collaboration with cross functional team members and in particular, clinical operations.
• Being responsible for Target Product Profiles (TPP) and strategic development plans.
• Working with the CMC team, clinical operations, and translational science team to project manage clinical activities for Phase I and II clinical studies.
• Working with the team to develop and translate project strategy into operational plans and budget that meets internal and external stakeholder requirements.
• Managing project team interaction with key collaborators and ensuring effective communication to maximise value of collaboration.
• Monitoring all project activities at external contractors and ensure appropriate timelines, budget and quality standards are met.
• Managing project budgets (forecast and active tracking) and maintaining active project plans (using MS Project), risk registers, and gap analysis.
• Contributing to the preparation of regulatory briefing documents and preclinical/clinical elements of regulatory submission documents.
• Demonstrable project management skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Chidozie Orji at +44 207 440 0671 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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