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Job Details

Senior Clinical Program Director

Company: Hobson Prior
Location: Germany
Reference: IQX-558669
Closing Date: 23 Jan 17
Type: Permanent
Salary (£): On Application
Benefits: €130-160,000

Job Summary:

Overview: My client is a global biopharmaceutical company who specialise in transforming the lives of people with severe diseases. They are currently seeking an enthusiastic and talented professional who would like to make a difference and deliver results.

Requirements:

Overview: My client is a global biopharmaceutical company who specialise in transforming the lives of people with severe diseases. They are currently seeking an enthusiastic and talented professional who would like to make a difference and deliver results.

At the earliest possible date my client is seeking a Senior Clinical Program Director.

Responsibilities include but are not limited to:

·         Accountable for all clinical aspects of their assigned programs

·         Lead and ensure adequate planning, design, defense, and implementation of the clinical development strategy including generation and appropriate revision of the Clinical Development Plan (CDP)

·         Ensures that study concepts, Protocol Summaries and final protocols related to the relevant development plans meet the requirements of related CDP(s) and TPP(s) as well as represent contemporary research approaches.

·         Contribute to the product development strategy by leading the development and subsequent revisions of the CDP and appropriate portions of the PLC while ensuring that both are compatible with the TPP and represent contemporary research approaches.

·         Lead the team in the planning and execution of high quality clinical components of regulatory submissions for the indication(s)/formulation(s) (e.g., study reports, summary documents). Review and contribute to such components. Responsible for on-time delivery of clinical components of regulatory submissions. Represent the company at meetings with Regulatory Authorities and partners, if applicable.

 

Requirements:

·         Masters with PhD preferred

·         8 years + clinical development experience including oversight of the planning and simultaneous management and reporting of multiple clinical studies.

·         Broad experience in writing and/or participation in the preparation of submission documents required (across or at time points along the continuum from original protocol to NDA/BLA to safety updates)

·         Typically, a Senior CPD has previously led a clinical program through phase 3, submission, and the regulatory approval processes.

·         Project management skills preferred.  Formal project management training a plus. Listening, coaching, mentoring, facilitation, influencing and negotiation skills.

 

Apply for the role of Senior Clinical Program Director using the form below, or contact us for more details.

 

 

 

 

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Apply for this job: Senior Clinical Program Director

Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

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