Director, Submission Program Management Leader

Job Description - Director, Submission Program Management Leader (2406224799W) Description Johnson & Johnson Innovative Medicine is recruiting for a Director, Submission Program Management Leader. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Los Angeles, CA; San Diego, CA; High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; or Allschwil, Switzerland. The Director, Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (J&J IM). The SPML will be responsible for leading global, cross-functional submission teams to meet or exceed the operational delivery goals for J&J IM’s major submissions in EU and U.S. markets and is the primary interface to J&J IM’s Compound Development Team (CDT) regarding operational submission strategy. This includes: Close partnership with the CDT, Therapeutic Area (TA) and Functional Leadership, working hand in hand with the Global Regulatory Leader (GRL) to facilitate alignment, clarity, understanding and endorsement of the overall submission strategy. Driving development of the end-to-end operational submission strategy in alignment with overall submission strategy and goals, ensuring alignment and commitment from functional leaders and team members. Oversight of operations/delivery process, leading the cross-functional submission workgroup(s) and partnering with responsible functional project managers and team members to drive planning, optimization, and execution. Close partnership with team and functional leaders to ensure adherence to best practices, proper risk mitigation and delivery enhancement strategies. Functioning as a Submission Launch Leader for new teams and engagements providing coaching and oversight to more junior SPMLs. This role may support submissions in Immunology, Oncology, Neuroscience, and Cardiopulmonary. The SPML (Director) may also take on formal direct reports. Qualifications: A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced degree preferred. A minimum of 10 years of industry/business experience is required. A minimum of 8 years of experience leading cross-functional teams in a matrixed work environment is required. A minimum of 5 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required. A minimum of 5 years of formal project management experience is required. A minimum of 2 years of people management experience is required. Demonstrated project management leadership of cross-functional submission teams is required. Experience conducting business process, scenario, and critical path analysis on complex projects is required. Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing application in the U.S. and EU is required. Project management certification preferred. Regulatory certification (RAC) preferred. Proficiency with Microsoft Project is highly preferred. Must have excellent verbal and written communication skills. Must have strong innovative and strategic thinking skills. This position will require up to 10% domestic and international travel. The anticipated base pay range for this position is 160000 to 276000. California Bay Area - The anticipated base pay range for this position is 197000 to 317400. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status.

#J-18808-Ljbffr