Global Clinical Leader, Oncology
YOUR TASKS AND RESPONSIBILITIES
• Responsible for less complex clinical development programs
• Leads the Global Clinical Team (GCT), a cross functional,
multinational team of internal experts, through clinical phase II – III
trials, global product registration, and ICMP trials supporting product
life cycle optimization. Sets project-related objectives with GCT
members and provides input to their annual performance evaluation (PMP completed by the
functional line manager). Requests GCD team members and clarifies resource availability
with global functional heads.
• May be a member of the Global Project/Program Team and member of the Global Brand team, as the Clinical Development Representative
• In consultation with relevant key disciplines, prepares the
Clinical Development Plan (CDP), including an operational plan with high level resource
planning (timelines, budget and manpower). Responsible for planning and managing the
clinical timelines, managing clinical budget (external clinical grants and CRO management
fees) and manpower against the approved CDP and approved resources. Proactively initiates
corrective action as needed.
• Responsible for the ongoing risk-benefit assessment of a compound until approval in a
main country. Analyses incoming clinical data,relevant medical and scientific information and
initiates actions or
decisions as appropriate.
• In consultation with the Group Head of GCL GPH, is responsible
for communication of medical project and study strategy, study results and clinical project
results to internal and external bodies (e.g.
regulatory authorities). Prepares assessments and recommendations at Decision Points, and
presents them together with the Global Project Head (GPH) to the Global Product Development Committee (GPDC).

• Responsible for defining the strategic approach and managing
preparation of medical sections of key Regulatory documents (ISE, ISS, expert report).
Consults with GCPPL, GIAPL (Global Integrated Analysis Project Leader), Global Regulatory,
Medical Science Physician, GDS.
Compiles and maintains Investigators’ Brochures (IB).
• Provides medical expertise to Global Strategic Marketing (for
marketed products) and Strategic New Product Marketing (for development projects) and
defines together with the Marketing Manager/SNPM Manager the publication strategy.
Accoun for internal publication process and ensures consistency of publications with
clinical data and publication strategy. Contributes to Opinion Leader development and
publications strategy with implementation detail. Establishes and maintains appropriate
external scientific advisory boards and assists in advocacy development.
• Provides medical assessment of in- and out-licensing
opportunities of development projects
• Approves domestic study concepts to ensure compliance with global strategy. Allocates
studies to the D&C countries together with the global heads of Clinical Operations and
Biometry, including patronage countries as needed
• Provides oversight of the Clinical Study Teams
• In consultation with senior leadership and/or the GPT, serves as
the escalation decision maker for changes to the agreed study plan

WHO YOU ARE:
• The incumbent is a highly successful M.D. with extensive professional and academic
experience. Board certification in a relevant therapeutic area is preferred.
Key competencies needed by the incumbent include the following:
• Proven leadership, motivational and interpersonal skills
• In-depth understanding of the drug development and
commercialization process with a base of experience of 5+ years in
Medical Science and drug development (From protocol writing to MRR).
• Must provide clear vision, direction, and purpose in the
different cultures present within the global Medical Organization
• Incumbent must embrace change and be able to work in a changing
environment
• Strong communication skills to ensure that project plans and
status are transparent, and that risks, issues, and results are clear to
all involved parties. A matrix structure requires additional skills in
gathering decision information, negotiation and communicating decisions
and action.
• Executes his/her responsibilities with knowledge, accuracy,
persistence, resilience and creativity seeking to work both
independently and collaboratively.

Salary: $200,000 - $250,000 USD

Bonus: NA

Relocation : No

Travel: NA

Additional Benefit Information:
Full Benefits Package -  401K

DISCLAIMER:  The above statements are intended to describe the general nature and level of work being performed by individuals in, or assigned to, the above position and are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required, and may be changed at the discretion of the Company.

Job Location -  Hanover, NJ