Global Clinical Leader MD

.pre {white-space: pre-wrap;} Your tasks and responsibilities

The primary responsibilities of this role, Global Clinical Leader MD, are to: 

 

  • Lead 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;
  • Set project-related objectives with Global Clinical Project (GCP) team members and provides input to their annual performance evaluation (PMP completed by the functional line manager);
  • Request Global Clinical Development (GCD) team members and clarify resource availability with global functional heads;
  • Be a member of the Global Project Team and Global Brand Team, representing GCD;
  • Prepare the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower);
  • Be responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and Contract Research Organization (CRO) management fees) and manpower against the approved CDP and approved resources;
  • Proactively initiate corrective action as needed;
  • Be responsible for the ongoing risk-benefit assessment of a compound until approval in a main country;
  • Analyze incoming clinical data, relevant medical and scientific information and initiate actions or decisions as appropriate;
  • Be responsible (in consultation with the Head of the Therapeutic Area (TA) and GPL), for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities);
  • Prepare assessments and recommendations at Decision Points, and present them together with the Global Project Leader (GPL) to the Development Management Committee;
  • Be responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (ISE, ISS, expert report);
  • Consult with Global Project Head (GPH), GIAPL (Global Integrated Analysis Project Leader), Global Regulatory, Medical Science Physician, Bio Stats;
  • Compile and maintain Investigators’ Brochures (IB);
  • Provide medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (SNPM) (for development projects) and define together with the Marketing Manager/SNPM Manager the publication strategy;
  • Approve publications and ensure consistency of publications with clinical data and publication strategy;
  • Contribute to Opinion Leader development and publications strategy with implementation detail;
  • Establish and maintain appropriate external scientific advisory boards and assist in advocacy development;
  • Provide medical assessment of in-and-out-licensing opportunities of development projects;
  • Approve domestic study concepts to ensure compliance with global strategy;
  • Allocate studies to the developing and core countries together with the global heads of Clinical Operations and Biometry, including patronage countries as needed.

     

.pre {white-space: pre-wrap;} Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Highly successful M.D. with a minimum  of ten (10) plus years of professional, academic or industry experience;
  • Proven leadership, motivational and interpersonal skills;
  • In-depth understanding of the drug development and commercialization process with a base of experience of five (5) plus years in Medical Science and drug development (from protocol writing to Medical Readiness Review (MRR);
  • Must provide clear vision, direction, and purpose in the different cultures present within the global Medical Organization;
  • 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;
  • Skilled 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.

 

Preferred Qualifications:

 

  • Board certification in Anti-Infectives or in a relevant related therapeutic area.

 

jgardiner

.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.