Early Development Asset Lead Director

**Summary / purpose of the position**
The EDAL is a critical role at Ipsen that has a significant impact on the development and life cycle of a therapeutic asset. The EDAL provides leadership and guidance for all aspects of the management and execution of partnered projects from drug discovery stages to early phase clinical trials. The EDAL will also be accountable for the planning and the implementation of detailed project strategy & plans covering all aspects of early clinical trials
from study concept to reporting according to timelines, budget, operational and quality standards. The EDAL leads the Early Development Team (EDT), a matrix team, including clinical, regulatory, CMC, translational, clinical pharmacology, nonclinical safety, and biomarkers in the Early Development phase to deliver the strategy and execution of the project plan. The EDAL will be responsible for these activities by providing strategic leadership to the cross-functional EDT and partnering with therapeutic area leaders to ensure that the team has
necessary resources to execute the project strategy. The EDAL will also serve as the champion for the project by articulating the project goals, scientific rationale, and clinical line of sight both internally and externally. The EDAL will demonstrate high visibility leadership to ensure that the team is motivated, empowered, and that diverse viewpoints are actively sought and evaluated by the team. Depending on pipeline needs, the EDAL may also represent the Early Development function in late-stage assets by serving as ED Subteam Lead in a
multidisciplinary Global Asset Team.

**Main responsibilities / job expectations**
- Leads one or more Early Development Asset Teams.
- For EDT, responsible for all aspects of project strategy, including preclinical, translational, clinical, and diagnostic activities.
- Ensures alignment of project goals that align with Therapeutic Area strategies and portfolio prioritization.
- Accountable for ensuring adequate resources to deliver projects according to budgets and timelines.

Integrate input from critical functions and research teams (internal/external) to develop plans that optimize balance of risk, timelines, cost, and commercial potential. Proactively identify risks and implement mitigation strategies.
- Present robust plans and data to enable governance to make investment decisions.
- Understands the science and has ability to present the project strategy in a capable / credible way, while deferring to functional experts as needed
- Accountable for overall leadership and effectiveness of EDT. Maintains a high degree of team effectiveness through collaboration, influence, and as needed, coaching.
- Drive high functioning team by clear communication of project vision and ensuring clear roles and responsibilities.
- Contribute and support department initiatives to implement cross functional/organization processes designed to effectively deliver Ipsen’s portfolio.
- Contribute to due diligence activities related to in-licensing of pipeline assets. Depending on level of experience, EDAL may serve as ED champion to support, coordinate and

communicate due diligence findings and team recommendations to Ipsen management at governance meetings.
- Depending on pipeline needs, EDAL may be nominated to act as ED Lead for late stage clinical stage projects governed by Global Asset Teams. In this role, the ED Lead will represent ED at the Global Asset Team (core member) and ensure proper communication of project goals and timelines. The ED Lead will also be responsible leading a cross-functional team of experts responsible for coordinating / delivering ED-related activities to support the Global Asset Team.

**Knowledge, abilities & experience**
**Education / Certifications**:
**Experience**:

- PhD, MD, PharmD or relevant advanced degree with minimum of 10 years of multi-disciplinary experience including pharm/biotech and/or academic experience.
- Extensive knowledge of drug development (and/or experience in more than one functional areas such as nonclinical/translational/regulatory/clinical) with in-depth understanding of oncology, neuroscience, or rare disease desirable.
- Experience developing and delivering translational strategy, including development and execution of biomarker / precision medicine strategies as part of clinical trials [required].
- Proven scientific/leadership expertise in matrix environment [required].
- Experience in mining of large datasets, either independently or in collaboration with bioinformaticians to understand disease pathophysiology and/or establish patient segmentation hypotheses [desired].
- Experience in regulatory filings and responding to health authority questions [desired].

Experience in interacting with CROs and KOLs to manage projects and timelines [desired].
- In-depth understanding of all aspects of drug development from discovery to life cycle management [desired].

**Languages**:

- Proficient in written and or