The primary responsibilities of this role, Global Clinical Leader Pediatric MD, are to:
Global clinical development "point of contact" for the assigned pediatric project within Oncology responsible for the overall medical and scientific direction and support of product development from early research to launch;
Serve as an internal pediatric medical expert for products and disease-related content, pharmacovigilance teams, and assessment of in and out-licensing opportunities of development projects;
Take responsibility for projects assigned, including pediatric indication selection, writing, Pediatric Investigational Plan, Pediatric study plan, clinical trial concept, IND, provide input in Safety Reports, and Investigator Brochures, data and statistical management plans.
Plan and manage the clinical timelines;
Contribute to planning of First in Man studies, determining clinical phase transition milestones, and analysis of incoming clinical data, initiating actions or decisions as appropriate;
Provide leadership in interactions with regulatory agencies. Contribute to submission strategy, regulatory dossiers, and medical oversight;
Serve as the chairperson of the cross functional pediatric global clinical or study teams. Represent the pediatric clinical and study teams at the global project team and other governing committees, as required for program performance;
Oversee and support contacts to external experts, advisory boards, adjudication committees, and data safety monitoring boards;
Review and approve publications within the project, in collaboration with the group head;
Identify the need for studies to be conducted as phase III/IV jointly with medical affairs, and provides input to medical affairs on scientific platforms, publication plans, and product maintenance;
Assure adherence to governmental regulations, company SOPs, and compliance.
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:
Possesses strong knowledge of pediatric disease state with either extensive academic or professional experience. MD required. Broad knowledge of Pediatrics is required. Board eligibility or certification in Pediatrics or Pediatric Hematology/Oncology is desired, but not a must. A candidate with strong experience across multiple therapeutic areas may also be considered, particularly any expertise or experience in women’s health, hemoglobinopathies, and hemostasis/coagulation;
Champions new ideas and initiatives. Initiates bold, yet well-reasoned projects and manages them independently;
Readily puts in extra time and effort; tackles problems and works to resolve them without delay; establishes high standards of performance;
Approaches problems with curiosity and open-mindedness; creatively integrates different ideas and perspectives; stimulates creative thinking in others; generates innovative ideas and solutions to problems;
Makes timely decisions based on accurate logic; looks beyond symptoms to identify causes of problems; makes decisions in the face of uncertainty; takes all important issues into account;
Understanding of the drug development process with a base experience of 5 or more years in medical science and drug development. Needs knowledge of study design, protocol writing, study performance, data collection and interpretation, as well as experience with interactions with IRBs, ethics committees or regulatory agencies. Broad familiarity of drug development, regulatory requirements, payer landscape and life cycle management;
Experienced and adept at working collaboratively within a matrix environment with multiple departments, including basic science, manufacturing, and commercial teams;
Flexible and able to work on multiple projects with aggressive timelines;
Must provide clear vision, direction, and purpose in the different cultures present within the global organization;
Creates plans that clearly define the organizations goals, milestones and results. Conveys clear expectations for deliverables; monitors progress of others and redirects efforts when goals are not being met; continually looks for ways to improve processes, products and services;
Executes responsibilities with knowledge, accuracy, persistence, resilience and creativity;
Establishes realistic plans, action steps and timetables for projects and assignments; identifies specific action steps and accountabilities; prepares realistic estimates of budget, staff and other resources;
Strong communication skills to ensure that project plans and status are transparent. Clearly articulates ideas, opinions and information. Keeps people up-to-date with information; encourages others to express their views, even contrary ones; speaks and writes clearly and concisely.
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.
Bayer is an Equal Opportunity Employer/Disabled/Veterans