Global Clinical Leader MD – Pulmonary/Anti-Infectives( Senior Director, Clinical Research

Location – New Jersey

Description

•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

 

Qualifications

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

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