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Director, Program Leader Late-stage Development
hace 2 semanas
For Organon we are currently hiring a:
**Director, Program Leader Late-Stage Development - Women’s Health**
- This is a global remote position and can be based in Jersey City or Plymouth Meeting (USA), or in the following locations in Europe: Oss or Amsterdam (The Netherlands), Heist-op-den-Berg (Belgium), Vienna (Austria), Lisbon (Portugal), Madrid (Spain), London or Cramlington (United Kingdom), or Dublin (Ireland). _
**The Position**
As part of a matrix organization in collaboration with CDS (Clinical Data Science), Safety, Clinical Operations, Regulatory, CMC (Chemistry, Manufacturing &Controls), Project Management, MAOR (Marketing Authorization and Official Release) and other Organon partners, the late-stage Clinical Leader will report to the Head of Program Leadership and will collaborate with various Organon partners to define asset development strategies. This role leads late-stage development programs and interacts with Regulatory Agencies for Life Cycle Management (LCM) programs, including labeling updates for in-line products.
Responsibilities include developing an aligned asset strategy, driving cross-functional program objectives, and providing input for decision-making within the governance model. You will represent ADT in discussions with governance bodies, balancing risk minimization, time-to-market, and budget reliability. Additionally, you will drive risk identification, mitigation, issue resolution, and stakeholder engagement to ensure the delivery of the development strategy and asset value.
**Responsibilities**
- In line with GCP (Good Clinical Practice), GPvP (Good Pharmacovigilance Practice) and relevant Organon SOPs, define study design, execution, data analysis, and communication of trials’ results in collaboration with cross-functional team members.
- Provide R&D leadership to the ADT(s) with a focus on building a global, high functioning team.
- Support Clinical Operations groups as needed for identification, management, executional and financial oversight of external vendors, including study-related CROs, if applicable.
- Partner with commercial regarding development and life cycle management opportunities for Organon’s pipeline and inline products.
- In line with the Organon governance structure, liaise with the senior management team for the approval of Development and LCM plans and studies.
- Engage and communicate effectively with global regulators, scientific leaders, and physicians as well as internal stakeholders.
- Provide scientific/ medical/ clinical strategic input to assessment of licensing and business development opportunities.
- Build strong, large and globally dispersed teams which are highly productive and efficient.
- Responsible for understanding global issues and helping stakeholders address them.
- Responsible for leverage internal and external networks to deliver on key priorities.
- Help Organon to develop talents and provide leadership and guidance to more junior members of ORD by sharing expertise and experience through mentoring and coaching.
**Required Education, Experience and Skills**
- MD, PharmD or PhD degree.
- At least 8 years of experience working with large global teams and in cross-functional scenarios.
- At least 5 years of relevant job experience (pharmaceutical / biotechnology). Solid experience and understanding of all levels of Clinical Development (Phase II-IV).
- Experience with the planning and execution of strategies for drug product registration and commercialization / life-cycle management.
- Drug and/ or medical device development experience.
- Demonstrated analytical and strategic skills and solid understanding of research methodology.
- Ability to work in cross functional teams and ability to organize, prioritize and work effectively in a changing environment.
- Ability to successfully influence and negotiate.
- Possess a high degree of integrity and personal ethic.
- Understand and manage, with appropriate support, the resources, time, and budgets for assigned projects; business-savvy and results-oriented.
- Proven ability to analyze, recommend, lead, and implement strategic vision, and process.
- Excellent written and verbal communication skills in English.
**Preferred Experience and Skills**
- Preference for a board certification in the therapeutic area of Women’s Health.
- Extensive product and women’s health expertise.
- Strong team leadership skills in a matrix organization.
Secondary Language(s) Job Description
**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthie
