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.
Clinical Development Leader
Bayer U.S. LLC's seeks a Clinical Development Leader for the Late Stage Oncology Program to work in Whippany, NJ and serve as a clinical lead for the Tyrosine Kinase Inhibitor (TKI) franchise at the study level and be responsible for clinical strategy, patient safety, and data integrity.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Clinical Development Leader, are to:
- drive the design, execution and delivery of the clinical development plan in collaboration with other cross-functional team members; including internal/external stakeholders and health authorities;
- assesses and ensure validity of efficacy data;
- serve as primary contact for study medical and patient safety aspects; and
- be responsible for the medical section of protocol, protocol conduct and site initiation visit.
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:
- MD degree (or foreign equivalent); and
- Four (4) years of experience in a clinical research or drug development position in the pharmaceutical industry;
- strategic insight into drug development, including virtual collaborations with international cross-functional teams, international regulatory authorities and their requirements, GCP/ICH guidelines and working within them, basic biostatistics, and electronic data review tools;
- managing international networks of internal and external stakeholders in a matrix environment;
- writing or contributing to clinical research protocols, informed consent documents, and communications with clinical investigators;
- training study teams, monitors, site staff and CRO staff on medical aspects of the study, indication and compound;
- making scientific and medical presentations to an international audience and also internal and external committees;
- assessing the validity of efficacy data in oncology clinical trials;
- electronic medical review tool systems and development of electronic Clinical Report Forms (eCFRs);
- overseeing and performing quality control of outsourced medical review activities conducted by partner CROs; and
- providing timely medical support and clarifications about clinical study protocols and procedures to CRAs in different time zones in both oral and written form.
- Experience can be concurrent.
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. 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.
State: New Jersey
Reference Code: 249261
Functional Area: Medical Affairs & Pharmacovigilance
Entry Level : Professional