Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Global Clinical Leader Thrombosis MD

Your tasks and responsibilities

 

The Global Clinical Development Leader will be responsible for strategic (phase II-III) and operational clinical development activities for development projects (phase II - III), as well as for clinical life-cycle management activities for marketed products, related the prevention and treatment of thrombosis. The initial primary objective of the GCL will be the clinical oversight of the on-going Xarelto COMPASS program, including continuation of the trial, its submission and labeling activities, and the companion LTOLE study, with later involvement in other development projects related to thrombosis.

 

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

 

  • Lead the Clinical Development (CD) Team, a cross functional, multinational team of internal experts, through clinical phase II – III trials, global product registration, and trials supporting product life cycle optimization;
  • Member of the Global Project Team representing CD and member of the Global Brand team, representing CD;
  • Prepare the Clinical Development Plan (CDP). Plan and manage the clinical timelines, manage clinical budget and manpower against the approved CDP and approved resources;
  • Complete risk-benefit assessment of a compound until approval in a main country;
  • Responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities);
  • Define the strategic approach and managing preparation of medical sections of key Regulatory documents;
  • Provide medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and define together with the Marketing Manager/SNPM Manager the publication strategy.

 

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:

  • The incumbent is a highly successful M.D. with extensive professional and academic experience;
  • 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, cultural diversity, 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.

     

Preferred Qualifications:

  • Board certification in a relevant therapeutic area.

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.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: NJ-Parsippany

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Oct 11, 2017   Copyright © Bayer AG
URL: https://career.bayer.us/opencms/opencms/job/Head-Study-Medical-Expert-Womens-Health-MD--SF8877.html