Pre-clinical Project Manager - Orsay, France - Immutep

Description

Employee


Location:
Orsay (IDF, France), Home-office.


Company:
Immutep (and its affiliates) is a globally active biotechnology company that is striving
to become a leader in the development of immunotherapeutic products for the treatment of cancer
and autoimmune disease.


General objectives of the position:

Pre-Clinical Project Manager (PPM) is responsible for managing development programs from
nonclinical stage to early clinical phases and for managing the non-clinical requirements for late
development stage programs (start of phase III or BLA). PPM will develop and manage detailed
nonclinical project plans that integrate multi-functional activities from internal and external
collaborators to ensure deliverables are aligned with regulatory and clinical expectations.


Responsibilities and tasks:

• Management of the Preclinical R&D Department related to IMP761 project
• Gathering information from various stakeholders regarding the project
• Conduct gap analysis to identify weakness and provide feasible solutions in

accordance to regulatory requirements

• Involvement in the design of in vitro, ex vivo and in vivo studies to ensure

appropriateness of nonclinical package and clinical bioanalysis

• Serve as main contact for outsourced activities including technology transfer, study

plans/reports review and interpretation of generated data

• Support Clinical and Regulatory Affair Teams to achieve goals (Study

Protocol/reports, Investigator's Brochure, Lab Manual, IND)

• Facilitate crossfunctional planning of deliverables / activities across departments

to align dependencies, schedules, and budgets.

• Participate to forecast budget, track budget and timelines to ensure project

success

• Organize Team meeting

Required Skills/Experience:

• PhD/postdoc in Immunology
• Previous experience as Project Manager
• Knowledge of international guidelines/principles/practices
• IT Knowledge Office
• Advanced English

Skills and Attitude:

• Team building skills
• Proactive and goaloriented way of work
• Excellent organisational and communicative skills
• Selfmotivation

If you are interested in this challenging career opportunity, please send your CV, certificate of