Head Strategy & Business Transformation
Company: J&J Family of Companies
Location: La Jolla
Posted on: September 24, 2022
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives
by finding new and better ways to prevent, intercept, treat, and
cure disease inspires us. We bring together the best minds and
pursue the most promising science. We are Janssen. We collaborate
with the world for the health of everyone in it, and we are guided
by our Credo: https://www.jnj.com/credo/ . Learn more at
and follow us @ JanssenGlobal. Janssen Research & Development, LLC
is part of the Janssen Pharmaceutical Companies. Portfolio Delivery
Operations (PDO), part of Global Development (GD), is responsible
for the operational strategy and delivery of the global clinical
portfolios across all the therapeutic areas within Janssen. The
Portfolio Delivery Operations (PDO) Head of Strategy and Business
Transformation reports to the VP, Head of PDO-xTA. They are
responsible for leading, in collaboration with the appropriate
stakeholders, a robust future ready strategy and continue to
identify opportunities under the global business transformation
tactical plan for the PDO organization. Evolutions in Clinical
Trials are occurring within both the internal and external
environment such as artificial intelligence, wearables, mobile
research application platforms, real-world data, home and community
alternative research locations, precision medicine (e.g.
biomarker-based trial qualification), advances in clinical trial
data and quality monitoring, and more, which impact how JnJ
conducts clinical trials worldwide. As a result, the PDO
organization is critical to the organizations adoption of
decentrialized trials and this role is tasked with partnering with
applicable stakeholders for this transformation. Additionally, the
changing regulatory and privacy landscape across our global
footprint requires constant assessment. This individual will play a
key leadership role in ensuring PDOss ability to partner with all
Global Development function to drive the adoption of future facing
initiatives that advance they way Janssen designs, deploys, and
successfully recruits for its clinical trials. Principal
Responsibilities: The PDO Head of Strategy and Business
Transformation will have the following principle
- Strategy Development for PDO
- Collaborates to develop a landscape of short-, medium- and
long-term roadmap representative of the future facing strategies
required to gobally advance the PDO organization. Creates
infrastructure (meetings, townhalls, working/strategy sessions)
that enables the successful collaboration of the three TA aligned
organizations of PDO that not only supports the three VPs but
allows for harmonized ways of working.
- Collaborates with Global Development and TA Strategy &
Operations Leads to provide insights to inform the central strategy
and approach to live into Better Trials Made Together.
- Partners with key functions to identify and implement process
improvement opportunities across PDO which includes but is not
limited to: Regulatory, Quality, Privacy, Legal, Clinical Supplies,
- Leads the planning, implementation and change management of
identified strategic iniaitives
- Acts a central point of contact within PDO for
internal/external collaborators for cross PDO inititiavives,
process improvement, and quality compliance and ensures
- Develop, deploy, and maintain suite of metrics and reports to
enable the organization to track performance and progress in
accordance with cross PDO goals and objectives
- Quality/Vendor Management & Compliance
- Serves as point of contact and partner with BQRC on PDO quality
management, compliance and concerns
- Manages team to ensure CAPA process and reporting are managed
and successfully resolved
- Identifies shared cross PDO vendors and coordinates
requirements, reporting, and relationships with PDO
- Liaise with Procurement, Legal, Privacy, etc. on vendor
onboarding, governance, and budget coordination
- Trials2You Program Leadership
- Partners with GCO Head of SBT in the designing and implementing
Decentralized Clinical Trials (DCT) in Janssen Research and
Development and Medical Affairs Operations.
- Leads a matrixed team of PDO experts in DCTs, including
individual product- or service- (capability) business owners, trial
design architects/consultants, and functional liaisons
- Serves as point of contact for PDO with a bias towards action
for Trials2You and effectively leads the organization to
- Partners with the Trials2You Process Owner as part of the
protocol concept value stream; acts signatory to PDO applicable
policies and SOPs
- Stakeholder Management
- Creates and builds collaborative relationships across the JnJ
organization in order to develop and delivery PDO strategy in an
effort to delivery innovative clinical trials.
- Pro-actively communicates with PDO leadership and draws in
expertise to advance the strategy
- Develops a robust Change Management and communication plan with
input from local and global communications partner to deliver
effective communication for/to PDO.
- Manage cross PDO strategic deliverables in a timely fashion and
in accordance with GD and PDO leaders.
- Implementation Planning and Delivery Oversight
- Influence or lead the design, structure and delivery of various
centralized capaclities, such as Standards & Methods, Processes and
Tools, Training & Coaching PDO University, Vendor Mgnt, (Training)
Compliance Principal Relationships: Primary Reporting Structure :
Reports to Head of Portfolio Delivery Operations -xTA. Leader of
S&BT Directors, Operations Excellence Directors, T2U team and
various support staff. Primary interfaces: Peers to members of the
PDO Leadership Team, Extended PDO LT members. Actively engage with
leaders of Global Development, Therapeutic Areas, and Enterprise.
QualificationsEducation and Experience Requirements:
- Bachelor's degree or equivalent required, preferably in Life
Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing,
Pharmacy). Advanced degree in a scientific discipline and/or
Masters degree is preferred.
- Minimum of 10 years of clinical research experience acquired in
pharmaceutical industry, CRO or investigational site.
- Expertise or experience working in novel clinical research
methods, particularly in digital and decentralized clinical
- Deep knowledge and experience in organizational and
- Excellent communication and leadership skills.
- P roven ability to foster team productivity and
- Ability to manage complexity under pressure.
- P roven track record of people and project management.
- Strong in strategy development , project execution, stakeholder
management, training and excellent interpersonal skills. Strong
decision-making and financial management skills.
- F lexibility to work in a rapidly changing environment with the
appropriate sense of urgency.
- E xperience in transforming organizations in response to b
- Effective issue resolution and ability to generate and
implement contingency plans for both productivity and quality
issues when required.
- Excellent knowledge of drug development, clinical research
operations and regulatory requirements including ICH-GCP, HCC and
- Ability to synthesize and evaluate data generated from various
reports and sources.
- Demonstrated skills in effective communication with various
internal and external stakeholders (e.g. investigational sites,
ethics committees, health authorities. etc.). Other:
- Operates with limited supervision.
- Proficiency in English .
- Computer literate .
- Strong interpersonal and negotiating skills.
- Excellent organizational skills and ability to collaborate and
handle multiple priorities within a matrix environment.
- Perform activities in a timely and accurate manner.
- Can travel internationally up to 25% of the time
- This position can be located in and report into an office in
the following Janssen locations: Beerse, BE, any of our offices in
New Jersey, Sping House, PA, the United Kingdom, La Jolla, CA and
San Francisco, CA. At Johnson & Johnson, were on a mission to
change the trajectory of health for humanity. That starts by
creating the worlds healthiest workforce. Through cutting-edge
programs and policies, we empower the physical, mental, emotional
and financial health of our employees and the ones they love. As
such, depending on location and subject to local legislation,
candidates offered employment may be required to show proof of
COVID-19 vaccination or, in certain countries, secure an approved
accommodation prior to the commencement of employment to support
the well-being of our employees, their families and the communities
in which we live and work. If you are invited to interview for the
position, your recruiter will advise on the vaccine requirement
status in your geographic location. Primary LocationUnited
States-New Jersey-Raritan-920 US Highway 202Other
LocationsEurope/Middle East/Africa-United Kingdom, Europe/Middle
East/Africa-Belgium-Antwerp-Beerse, North America-United States-New
Jersey, North America-United States-Pennsylvania-Spring House,
North America-United States-California-San Francisco, North
America-United States-California-La JollaOrganizationJanssen
Research & Development, LLC (6084)Job FunctionR&DRequisition
Keywords: J&J Family of Companies, San Diego , Head Strategy & Business Transformation, Other , La Jolla, California
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