Senior Clinical Development Leader- Oncology

The primary responsibilities of this role, Senior Clinical Development Leader, are to: 

• Execution and delivery of the clinical development plan in collaboration with other cross-functional team members;
• The incumbent is responsible for developing drugs safely and effectively:
  • Translate Target Product Profile into clinical strategy;
  • Responsible for study medical/safety aspects and risk-benefit assessments; supported by Pharmacovigilance (PV) and CDS
• Assess and ensure validity of efficacy data;
• Interpret medical data to identify possible patient safety and data integrity issues; is primary contact for study medical and patient safety aspect;
• Lead and manage relationship with key internal/external stakeholder (eg Study Team, Key Opinion Leaders (KOL), health authorities);
• Responsible for medical section of protocol, train internal/external stakeholder (eg Study Team, Site Staff) and perform the protocol review during the site initiation visit;
• Ensure Clinical Study Report (CSR) medical content adheres to acceptable medical standard;
• Individual may be representing the team to other decision/governance meeting, senior management or advisory boards as applicable;
• May be responsible for supervising/mentoring multiple studies/clinician.

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:

• MD required;
• Ideal candidate will have experience in several of the following areas:
  • Experience in exploratory clinical drug development specific to Oncology;
  • Experience in the drug development and commercialization process;
  • Understanding of the complexities and recent developments in the oncology;
  • Understanding of issue related to the design and performance of technologically demanding trials;
  • Confident to discuss scientific/mechanistic aspects of drug development;
  • Familiar with the regulatory and legal environment;

• Strong communication skills (fluent in English both written and spoken) to ensure that project plan and status are transparent; risk, issue and result are clear to all involved parties;
• High level of comfort/success working in a matrix environment (global/multi-cultural/cross-functional);
• This includes contributing to a  trust environment: clarity, collaboration and results oriented;
• Demonstrated leadership skills both as an individual contributor or team leader;
• Networking and alliance management.

Preferred Qualifications:

•  PhD in addition with 5-8 yrs experience;
• Specialized experience in Oncology strongly preferred;
• Board certified in Oncology strongly preferred.

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.       

Division: Pharmaceuticals   Location: United States : Massachusetts : Cambridge || United States : New Jersey : Whippany    

Functional Area: Clinical Development & Operations     

Employment Type: Regular  Work Time: Exempt