Title:
Director, Global Clinical Development Programs, Aesthetics

Company:
Ipsen Biopharm Ltd

Job Description:

About Ipsen

We are Ipsen - a global, mid-size pharmaceutical company focusing on areas of high unmet medical need. We're 5,000 employees strong, generating over €3bn in revenue annually, and with products registered in over 80 countries. We're improving people's lives and health outcomes by focusing on areas of high unmet medical need, and we're accelerating our momentum and rapidly boosting our pipeline to bring the full potential of our innovative medicines to patients across Oncology, Rare Disease and Neuroscience.

Aesthetics@Ipsen

Spearheading the development of our new therapy area in Aesthetics, we are looking for talent for a number of key leadership positions who will play crucial roles in our strategy and execution at this exciting phase in our journey, in an environment that can offer unique career development opportunities on a global scale.

About the role

This is a key leadership position working directly for the VP, Clinical Development (Neuroscience), leading all clinical development operations aspects for current and future clinical activity with Aesthetics. You'll be hands on with study management, ensuring cross-functional oversight of all program and study related activities.

Key Responsibilities

1. Design, implementation strategy, resourcing and budgetary planning for Aesthetic clinical programs.
2. Accountable for forecasting CDO resources (internal/external).
3. Accountable and responsible for outlining the clinical operations strategy to deliver on the clinical development plans.
4. Ensures that the timelines and all key deliverables for the clinical study are followed and appropriately shared and aligned.
5. Responsible and accountable for ensuring all the clinical studies within the program are delivering on time and within budget.
6. Contributes as required to advisory boards, expert scientific committees, and on submission teams.

Experience required:

1. Extensive Aesthetics Clinical Operations experience and knowledge, specific experience in managing Ph1-3 global aesthetic medicine clinical studies/programs and managing pivotal filing studies and global submissions.
2. Proven experience in hands-on study management, executing at pace.
3. Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.#J-18808-Ljbffr