Job Description

Job Title:

Director, Clinical Scientist (Neuroscience)

Division / Function:

Clinical Development

Manager's Job Title:

Senior Director, Clinical Development Aesthetics Lead (Neuroscience) Michael Cecerle

Ipsen Job Profile:

Clinical Science > Clinical Development > Clinical/Medical Development

Location:

London UK or Paris France

WHAT -

Summary & Purpose of the Position

Providing leadership and management within Clinical Development (CD) to provide scientific and clinical development support for products within assigned therapy area. Support development and execution of medical & clinical strategy for assigned Ipsen product(s). Ensure concise written reports are provided as needed Act on behalf of Medical Monitor leading the interpretation of trial data and development and review of clinical study documents, reports etc. Support Medical Monitor to provide scientific leadership in execution of clinical trials Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, biostatistics, data management, and pharmacovigilance to ensure quality processes and deliverables Assist in the review, analysis and reporting of clinical trial data Assist with ongoing monitoring of safety data and regular medical review of clinical trial data. Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution

WHAT -

Main Responsibilities & Technical Competencies

Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings. Remains up to date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities. Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs. Leads development of clinical studies and reviews clinical protocols, related documents, and clinical study reports for scientific and operational accuracy. Participates in drug safety surveillance for Development projects. Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions. Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

Expertise in aesthetic drug development highly desired, but not required Demonstrated in-depth understanding of drug development and pharmaceutical marketing within therapy area. Working knowledge of regulations relating to drug development and promotional activities Demonstrated ability to communicate and plan effectively with other Ipsen departments and to respond to inquiries or complaints from customers. Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.
Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Ipsen; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results


Knowledge & Experience (preferred):

5+ years experience of clinical research and organizational management within the pharmaceutical industry, a CRO, or similar organization. Demonstrated ability to collaborate in a matrixed environment Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or Experience in designing and conducting Phase I-III clinical trials; and/or significant late-stage development research

Education / Certifications (essential):

Bachelor's degree or nursing qualification is required. Scientific/healthcare field preferred but not required.

Education / Certifications (preferred):

Advanced degree preferred in a relevant area to support the activities of a clinical scientist

Language(s) (essential):

English

Language(s) (preferred):

English

Other Useful Information

Key internal stakeholders:

Position is accountable to the Medical Monitor

Key external contacts:

Key academic, regulatory, professional leaders.

Travel requirements:

Availability to travel approximately 25% of time. * Availability to participate in early or late meetings/teleconferences.