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.

Director, Lead Clinical Imaging Strategist Oncology Development

Your tasks and responsibilities

 

The primary responsibilities of this role, Director, Lead Clinical Imaging Strategist, Oncology Development, are to: 

 

  • Responsible for ensuring that oncology clinical programs are using appropriate imaging techniques from preclinical through registration phases of development, including working with preclinical groups and development teams as part of the drug development process;
  • Employ state-of-the-art imaging strategies and techniques in working with preclinical groups and clinical teams to suggest potential imaging approaches that will help in the development of new drugs;
  • Strategically influence the use of imaging biomarkers for decision making purposes from D2 through to D8 and will strive to improve the overall excellence in this area by relying on resources throughout the organization, in particular in Drug Discovery and Development and by leveraging external relationships;
  • Ensure regulatory acceptance of imaging biomarker programs;
  • Collaborate with Global Clinical Imaging Strategists (GCIS) in developing imaging strategies and support as well as monitor their operational implementation jointly;
  • Establish a Bayer internal joint oncology imaging working group with the SBU Oncology representative and the GCIS;
  • Assist in the selection of Clinical Research Organizations (CROs) for image collection and review of studies and may oversee the review of images to assure they meet Good Clinical Practice (GCP) and regulatory requirements on behalf of the Oncology SBU;
  • Act responsible for assigned development programs with regard to advising appropriate use of imaging techniques and appropriate imaging charters and image collection;
  • Serve as a member of the Global Program Team (GPT) when required;
  • Provide relevant Oncology expertise to GPT when evaluating and developing translation and imaging strategies;
  • Act as thought partner to early research leaders, proactively following early projects prior to D2, and taking an active role from D2 onwards, assembling resources for subsequent imaging activities on the project on behalf of the Oncology Strategic Business Unit (SBU);
  • Ensure coordination of all aspects of imaging delivery in synchronization with the drug R&D process, informed by deep understanding of clinical development in Oncology and state-of-the-art imaging including use as a biomarker strategy;
  • Own, source and develop imaging knowledge to support Bayer differentiation and registration strategy, when necessary;
  • Define, communicate and execute on the imaging strategy for each development program where he/she is assigned; represent imaging related aspects internally and externally in meetings with authorities and ethics committees, and with external key opinion leaders; build and maintain network with academic institutions/diagnostic companies/imaging companies including CROs in Oncology;
  • Work closely with Early Development Program Leaders/Global Development Leaders (EDPLs/GDLs) as well as Early Clinical Leader/Global Clinical Leader (ECL/GCL) and GCIS team to ensure imaging strategy has maximum success rate;
  • Lead via internal and external collaborations the development of imaging tools to measure response/effectiveness of drug being developed;

Who you are

  • Be nominated as Early Clinical Leader (ECL) if qualified; He/she may present to internal decision making committees, act as a representative to GPT(s);
  • Independently analyze, interpret and present results from imaging analyses and draw scientifically valid conclusions that support and enable decision making.

 

This position is eligible for domestic relocation assistance

 

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:

 

  • Medical Doctor (M.D.) trained in Radiology or equivalent experience as related to the industry;
  • Proven track record of research and/or clinical development in Oncology, including minimum eight (8) years of industry experience;
  • Maintain a thorough understanding of imaging and clinical development in oncology; including experience with regulatory framework for biomarkers, and use of imaging for registration of Oncology products;
  • Outstanding scientific reputation as evidenced by multiple publications in peer reviewed journals and as speaker of conferences; strong network in the academic and clinical community of Oncology;
  • Strong leadership skills, comfortable to marshal resources from different parts of the organization in the absence of formal reporting lines;
  • Excellent interpersonal and communication skills (fluency in English, oral and written);
  • Confident team player, assertive but willing to listen and to seek and learn from the views of others;
  • Strategic influencing skills with experience in stakeholder management at leadership team level;
  • Able to set and communicate a strategic vision.

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-Whippany

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Oct 10, 2017   Copyright © Bayer AG
URL: https://career.bayer.us/opencms/opencms/en/job/Senior-Feasibility-Strategist--SF9684.html