Clinical Development Leader for Immuno-Oncology
The primary responsibilities of this role, Clinical Development Leader for Immuno-Oncology, are to:
- serve as the lead for the early clinical team and be responsible for the exploratory clinical development of drug candidates until transition to late stage development, driving the design, execution and delivery of the early clinical development plan in collaboration with other cross-functional team members;
- be responsible for the medical/safety aspects and risk-benefit assessments;
- assesses and ensures validity of efficacy data;
- review and interprets medical data to identify possible patient safety and data integrity issues;
- leads and manages relationships with key internal/external stakeholders;
- trains internal/external stakeholders and performs the protocol review during the site initiation visit and may be representing the team to other decision/governance meetings, senior management or advisory boards as applicable.
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) plus four (4) years of clinical practice experience in either oncology or immunology with clinical research experience;
- four (4) years of experience in oncology clinical drug development;
- exploratory early clinical drug development specific to Oncology;
- the complexities of and recent developments in Oncology;
- global clinical research, basic biostatistics, safety reporting, and working with/within GCP;
- writing clinical research protocols, informed consent documents, and communications with clinical investigators;
- training study teams, monitors, site staff and CRO staff (if applicable) on medical aspects of the study, indication and compound;
- developing Clinical Study Protocols and acting as a medical monitor for clinical research trials;
- electronic medical review tool systems;
- reviewing, preparing and delivering live safety data presentations for internal and external committees;
- discussing and presenting the scientific/mechanistic aspects of drug development; and
- the relevant regulatory and legal environment.
Must be able and willing to travel domestically and internationally to attend both internal and external business meetings and workshops several times per year.
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.
Location: United States : New Jersey : Whippany
Reference Code: 42102
+ 1 888-473-1001, option #5