Location – New Jersey
•Leads the Global Clinical Development (GCD) Team, 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 GCP team 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.
•Member of the Global Project Team representing GCD and member
of the Global Brand team, representing GCD
•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 Head of the Therapeutic Area (TA) and
GPL, 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 Leader (GPL) to the Development Management Committee.
•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. Approves publications 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
The incumbent is a highly successful M.D. with extensive professional
and academic experience. Board certification in Pulmonology or in a
relevant related therapeutic area is preferred but not a must. Key
competencies needed by the
candidate 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
•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
•Executes his/her responsibilities with knowledge, accuracy,
persistence, resilience and creativity seeking to work both
independently and collaboratively