Pre-clinical Project Manager

il y a 10 heures

Orsay, France Immutep Temps plein

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 cross-functional 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/post-doc in Immunology
- Previous experience as Project Manager
- Knowledge of international guidelines/principles/practices
- IT Knowledge Office
- Advanced English

**Skills and Attitude**:

- Team building skills
- Pro-active and goal-oriented way of work
- Excellent organisational and communicative skills
- Self-motivation

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

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