Associate Clinical Director

For our client, a multinational late-stage biotech company,

we are seeking an experienced clinical professional to help us lead in the clinical aspects of project management activities in close collaboration with her/his counterparts in CMC and regulatory.

**Essential duties and responsibilities**:

- Manage clinical data (tables, listings, SAP, IB, PK, safety ), clinical content of dossiers and clinical documents with focus on details and understanding of basic statistics
- Implement the project management control and tracking by coordinating vendors, consultants and internal resources
- Develop and maintain submission content plans, track documents from authoring to approval
- Manage the clinical pre
- and post-submission activities, preparations for health authority meetings and additional major regulatory milestones
- Manage submission dossier deliverables in collaboration with the CMC and regulatory team
- Identify and assess risks associated with development programs and define strategies to mitigate risks

**Qualifications**:

- Graduate degree in a healthcare discipline and ideally a strong background in Project Management
- 5-8 years of relevant clinical operations experience
- Medical background
- Extensive knowledge of global submission standards (FDA, EMA, etc.)
- Thorough knowledge of ICH and GCP requirements
- A minimum of 5 years of industry/business experience, including a minimum of three years in pharmaceutical / device R&D
- Experience in development of clinical strategy, and clinical support of global regulatory submissions and processes in various phases of the drug/device development cycle
- Ability to drive and expedite team decision making and translating strategy into a clear and executable action plan
- Clinical operations experience ideally in rare diseases preferred, as well as a track record in supporting NDA submissions to FDA