Asset Lead, Elafibranor
Title:Asset Lead, Elafibranor
Company:Ipsen Bioscience, Inc.
The “Asset” Team Leader is accountable for maximizing and delivering “Asset” value targets. As a team leader, he/she will lead/co-lead a cross-functional Global “Asset” Team to successfully define and deliver the integrated asset strategy and plan, which will include development, manufacturing, regulatory, access and commercial plans during a period of the asset life cycle. He/She will be accountable for achieving agreed upon milestones and KPIs for asset. The Asset Lead will also be a key member of alliance meeting and working group meetings with our in-licensing partner and foster the spirit of collaboration and mutual respect in order to achieve operational excellence pre, during and post transition activities. As a visionary leader with an entrepreneurial style, he/she will have passion to create opportunities, solve problems and to successfully drive complex projects. His/Her influencing and engagement skills will allow him/her to build highly motivated team and manage key stakeholders including ELT members. His/Her role will be key in the provisioning of successful product development, scientific and commercial excellence.
Main responsibilities / job expectations
Main responsibilities and tasks
- Lead the cross-functional Global “Asset” Team to build the vision and strategy to maximize value of the “Asset”
- In partnership with the Global “Asset” Team, he/she will:
- Create scientific and commercial value from early development to initial approval, from late development phase to patent expiry, adapted for each asset
- Own the overall program strategy, establishes project goals and leads a cross-functional team to meet the program objectives
- Outline an integrated development strategy that shapes the competitive and prescription landscape
- Translate the strategy into an efficiently executable high-level roadmap with clear priorities
- Oversee operations, ensure a strong alignment with all functions, and drive operational excellence in execution, with support of a project manager.
- Identifies opportunities through bold and disruptive leadership, starting with a vision translated into robust planning based on internal and external insights.
- Maintains good scientific, technical and clinical expertise in the specific therapeutic area. Critically reads and evaluates relevant medical literature with good understanding of the data and deep status from competitive products and with said knowledge develop a life cycle management strategy.
- Collaborate, co-lead and/or delegate responsibilities with (Sr)MDD regarding all alliance activities with in -licensing partner during the products life cycle with activities aligning with the licensing agreement, and support of all alliance meetings and working groups. Assist in-licensing company with ongoing Phase 3 pivotal 2L PBC study for accelerated approval inclusive of global filing responsibilities, lead the transition of Phase 3 study for open label long term safety portion; gain agreement with regulatory authorities on the study design for the second confirmatory 2L PBC study and plan life cycle management activities (eg, PSC, 1L PBC sub groups) and ensure launch readiness for all functions.
- Serve as cross-functional leadership and voice for the product within the corporation from decision to
- Set short- and long-term product strategy and operational priorities within corporate priorities. Accountable for driving and coordination of development, registration, launch and market facing activities and LCM according to product strategy and set on a course to maximize both near- and long-term value. Lead communication platform across all key internal and external stakeholders
- Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders
- Entrepreneurial, leadership and influencing skills are key to successfully mobilizing all necessary resources on the right priorities across functions
- Together with functions, outlines the resource and internal/external needs for the 5Y plan, to ensure the right allocation of efforts and resources to maximize value and to challenge resource allocation across functions.
- With the support of a strong project manager, ensures that a comprehensive risk mitigation plan is maintained and implemented to address potential risk to the Asset
- Role model and ambassador for the Asset and for IPSEN with our internal partners and external collaborators, with representatives from the scientific community and health authorities, and in any interactions with health care practitioners and patients.
- Define and implement a communication strategy / plan for asset
- Serves as the spokesperson for the Asset, reporting progress, risks and issues to functional and executive leaders.
- Represent the interests of the asset at the Governance Committee
- If appropriate, be accountable for effective management of the Company’s partners, all medical and scientific accounts including contribution to Joint Steering Committee +/- Development and/or Commercial Committees
- Builds and effectively leads high performing and motivated cross-functional teams and succeeds through authentic leadership at the highest levels
- Together with each function head, sets objectives for the dedicated members of the Global “Asset” Team and assesses individual performance for objectives linked to the asset
- Complete all above activities within the framework and in compliance with R&D SOPs, external GCPs and guidelines as well as other relevant policies in force within the Ipsen Group or under national and/or international authorities under which jurisdiction Ipsen is operating.
- Create a continuous improvement mindset and finds innovative ways of working and creating a constant learning environment leveraged through benchmarking (eg: bold regulatory strategies, open-innovation partnership, competitive intelligence)
- Set performance expectations with functions and serve as key evaluators of performance
- Leads rapid response in case of unexpected events involving products
- Requests talent from functions and solicit, accept and turn down individuals on team
Knowledge, abilities & experience
Education / Certifications:
- Advanced degree in Medical or Life Science, MD, PhD or MBA or equivalent experience. (to be adapted for each asset)
- Proven and respected leader with:
- At least 10 years in pharmaceutical industry in significant clinical development leadership positions, with proven track record (successful achievement of key milestones (Phase III; NDA submission and approval)) coupled with outstanding business acumen
- And/or at least 10 years in pharmaceutical industry in significant commercial leadership, medical affairs leadership or general management positions including working with development and manufacturing teams in cross-functional setting, with exceptional track record of delivering on business objectives, activity/milestones leading to filing and launching, and, with strong knowledge in the therapeutic area
- Outstanding sense of urgency and ability to pace the team’s work to achieve milestone achievement in highly competitive environment
- Outstanding customer and patient focus
- Market-relevant experience of therapy area, including the competitive landscape and Key External Experts is an advantage.
- Proven experience as an inspirational, empowering leader in a strategic and global environment
- Visionary, strategic, “right to left thinking” and entrepreneurial spirit with a passion to solve problems and to drive team performance
- Ability to manage and lead by influence complex projects with ambitious milestones in a cross-functional team environment and high-pressure circumstances
- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
- Cross-cultural awareness with a demonstrated ability to work with a cross-functional team to gather appropriate inputs, challenge ideas, come to a clear decision, align on priorities and track performance.
- Outstanding stakeholder management skills and confidence with senior leaders Innovative mindset (scientific & commercial)
- Global business acumen (from scientific to manufacturing to market – ability to develop full fledge BC)
- Prioritization and decision making
- Budget management and financial planification
In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated against the Covid 19 virus at the time of employment.IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.