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Position Summary:
The Therapeutic Area (TA) Leader is the single point of accountability for the delivery of the TA portfolio for Global Development (GD). The scope of the position includes R&D clinical programs in development through registration and approvals. The TA Leader is ultimately accountable for the successful GD delivery of all clinical programs within the assigned TA and will drive cross-functional operational strategies within GD to execute the TA, Integrated Solutions trials and / or Business Area portfolio.
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Successful delivery means within timelines and budget and with good quality. This position ensures common operational issues/challenges are identified across programs and across GD functions and addressed through operational risk mitigation / appropriate escalation to the TA, including proposals for alternative solutions. This position is accountable for ensuring operational execution for all programs regardless of delivery model.
This position ensures there is alignment of TA goals with GD organizational objectives. This position partners closely with TA leadership to drive and operationalize compound development strategy and to optimize portfolio value. This position ensures the GD functions have a good understanding of the portfolio and priorities to allow the functions a pro-active capability building. This position will be responsible to deal with conflicts in priority setting and related resourcing.
This position has direct interface with the correspondent SDS, IDAR, Clinical Supply Chain, DPDS, TA and GD Finance, Functional Planning, Procurement, Quality & Compliance and senior management in the management of the portfolio.
This position leads both clinical and project leadership roles, including Project Management Leaders (PMLs) and Program Delivery Leaders (PDLs). The incumbent serves as GD representative to TA governance, contributing strategic insights to prioritization and decision-making based on accurate data. TA Leader is accountable for the management and development of staff within his/her scope of responsibility while fostering a diverse workforce that works seamlessly in a highly matrixed environment.
Manages portfolio across multiple indications within a given TA. Within Medical Affairs Operations manages >60 internal budget owners at the Global/Regional/Local level.
Principal Responsibilities:
- Accountable for the delivery of the TA portfolio and ensures risk (regulatory, CMC and/or clinical) mitigation/escalation and mitigation of critical issues across assets is managed
- Brings deep drug development experience and expertise to provide early input into the development of integrated asset plans and business development (L&A) opportunities
- Ensures common operational issues/challenges are identified across programs and across functions and addressed through operational risk mitigation / appropriate escalation to the TA, including proposals for alternative solution
- Partners closely with other GD liaisons (e.g., SDS, GCO, IDAR) and TA leadership to drive and operationalize compound development strategy and to optimize portfolio value
- Provides strong leadership, functional management and people development responsibilities in a cross-functional matrix organization with leads both clinical and project leadership roles reporting to the TA Leader, and ensures staff and resources are deployed according to TA priorities
- Adopts, practices, and strengthens PM, Engagement and Feasibility strategies from Anchor Points and across JRD to enable optimal delivery of the TA portfolio
- Serves as representative to TA governance, contributing strategic insights to prioritization and decision-making based on accurate data
Principal Relationships:
Internal: Contacts in the organization include but are not limited to: R&D Portfolio Delivery Head, Head of Global Clinical Operations, Global Development colleagues, Quantitative Sciences TAL, Finance Department, Quality & Compliance, Project Management Organization and appropriate members within the Therapeutic Areas (TA Head, development Head, DAS and Commercial stronghold leaders, SOSL), Strategic Partnerships, JRP. This position reports to the Delivery Unit Head and has a dotted reporting line into the Therapeutic Area.
External: Multiple vendors, CRO's.
Qualifications
BS. Degree required. Advanced degree preferred (MS., MBA, PHD, MD).
Experience in a scientific discipline, with clinical and/or biologics drug development, strategic planning specifically in the pharmaceutical or biotech industries is preferred. Experience in managing external stakeholders/CROs as well as experience in leading registration programs is preferred.
Required Knowledge, Skills and Abilities:
- A minimum of 15 years with progressive leadership experience in the Pharmaceutical industry. Specific experience in clinical trial operations required.
- Demonstrated Clinical Trial Operations experience in Medical Affairs required.
- Successful demonstration of leading large groups successfully through change management is required
- Successful track record of developing talent and leaders of leaders is required
- Strong ability to make, impact and influence difficult decisions, proven experience in establishing and maintaining executive level relations and managing a diverse set of stakeholders leveraging a broad base of tactics is required
- Strong ability to develop, maintain and influence stakeholder relationships internally and externally with Sr. Management (TA Leadership, Finance, GD Leaders, Business Development etc) is required
- Proven track record of collaboration across organizations to innovate, implement efficiencies and drive complex change
- Experience in working in cross-functional teams and managing large projects - change management/leadership experience in driving change and influencing in a complex environment
- Trusted, inclusive leader with demonstrated experience in managing and mentoring cross functional, global teams is required
- Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environment is required
- Excellent communication skills required
- Sound financial acumen is required
- Driving a Credo-based culture, including building and developing a diverse and inclusive environment is required
- Proven track record of enterprise leadership and ability to build high performing teams. Creating a culture of collaboration, transparency and enterprise mindfulness.
- Establishing an outside in approach for both external and internal partnerships
- Other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
Location:
The position can be based in Raritan NJ, US; Beerse, Belgium or Allschwil, Switzerland and will require up to 20% domestic and international travel as needed.
The anticipated base pay range for this position in US is 187,000 to 322,000 USD.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.