【ジョンソン・エンド・ジョンソン株式会社】Program Delivery Leader, MA DU
仕事内容
形容
Program Delivery Leader (PDL)
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
The Program Development Leader (PDL) is crucial in the operational execution of the Clinical Development Plan (CDP). Acting as a disease area thought partner, the PDL is responsible for developing program-level strategies, ensuring cross-functional alignment, and identifying and resolving risks that could impact timelines or budgets.
Major Duties & Responsibilities
Program Strategy Development:
Develop and implement the program-level operational strategy, ensuring alignment across functions, delivery units, and therapeutic areas. This includes maintaining end-to-end connectivity from Global Development and non-Global Development partners, sharing lessons learned for program-level consistency, and monitoring critical metrics to track program-level success.
Operational strategy execution:
Deliver the operational strategy in alignment with the Clinical Development Plan, ensuring it meets business goals and clinical trial delivery objectives. This includes resourcing, budgeting, change control, and collaborating with CDT sub-teams on timeline creation. Attend CDT meetings and co-lead Clinical Teams (CT) in collaboration with clinical leaders.
Risk management and scenario planning
Lead scenario planning and mitigate program-level risks that could impact timelines or budgets. Ensure appropriate quality oversight and bring up issues to clinical teams, CDT, quality, and functional leadership as needed.
Communication and advocacy
Optimally communicate the operational strategy and defend the operational plan and associated costs to CDT, therapeutic area leadership, and governance meetings.
Other duties:
Ensure inspection readiness through risk identification and readiness review.
Lead Health Authority inspections and develop risk mitigation plans for key issues.
Support licensing and acquisition activities as appropriate.
Mentor and support onboarding of new team members, particularly in Trial Management.
Foster employee engagement, inclusion, and Credo behaviors.
応募資格(必須経験など)
資格
Required Qualifications
Education:
BS degree or equivalent.
Experience:
Minimum of 10 years in the pharmaceutical industry.
Knowledge, Skills, and Abilities:
Extensive knowledge of the pharmaceutical development process.
Clinical research operational knowledge and experience across multiple study phases (Phase I-IV).
Proven leadership skills with the ability to foster team efficiency and cohesiveness.
Experience leading without authority in multifunctional, matrixed, and global environments.
Strong decision-making, analytical, and financial leadership skills.
Capable of operating and executing with limited supervision.
Experience in mentoring and coaching others.
Excellent project planning, management, communication, and presentation skills.