Director, Clinical Science, Aesthetics

Overview

Job Title: Director, Clinical Scientist (Neuroscience)

Division / Function: Clinical Development

Location: London UK or Paris France

Manager’s

Job Title:

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

Ipsen Job Profile: Clinical Science >
Clinical Development >
Clinical/Medical Development

• Providing leadership and management within Clinical Development 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.

• Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
• Stay up to date with pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge; ensure consistent best practice across activities.
• Provide expert scientific clinical development leadership to project teams for the development of Phase I-IV clinical programs.
• Lead development of clinical studies and review clinical protocols, related documents, and clinical study reports for scientific and operational accuracy.
• Participate in drug safety surveillance for Development projects.
• Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
• Interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.

Essential

• Expertise in aesthetic drug development highly desired, but not required.
• In-depth understanding of drug development and pharmaceutical marketing within therapy area.
• Working knowledge of regulations relating to drug development and promotional activities.
• Ability to communicate and plan effectively with other Ipsen departments and to respond to inquiries or complaints from customers.
• Ability to effectively present information to senior management, employees at all levels, 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 backgrounds to improve service to present and future customers and to deliver business results.

Preferred

• 5+ years experience of clinical research and organizational management within the pharmaceutical industry, a CRO, or similar organization.
• 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.

Essential

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

Preferred

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

Essential

• English

Preferred

• English

• 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.
• Current Working-Type Possible For The Position (tick As Appropriate): Fully on-site, Hybrid, Fully Remote. In line with Ipsen Hybrid Working Policy.

Notes

The statements contained herein reflect general details as necessary to describe the principal functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or balance workload.

This description is not intended to be exhaustive and may change. All Employees are expected to adhere to company policies and values.

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