Early Clinical Lead- Immuno Oncology in Whippany, New Jersey | DiversityInc Careers
 
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Early Clinical Lead- Immuno Oncology

.pre {white-space: pre-wrap;} Your tasks and responsibilities

The primary responsibilities of this role, Early Clinical Lead – Immuno Oncology, are to: 

 

  • Lead the early clinical team and be responsible for the exploratory clinical development of drug candidates (until transition to late stage development);
  • Be accountable and responsible for coordinating the design, execution and delivery of the exploratory clinical development plan, through Proof of Technology (PoT) as well as the clinical pharmacology plan in partnership with other Translational Medicine Oncology (TMO) and Strategic Business Unit (SBU), with input from and consensus with other groups e.g. Therapeutic Research Groups (TRG), Global Early Development (GED), Global Regulatory Affairs (GRA), and commercial functions;
  • Act as the primary TMO team representative to the Global Project Team (until transition);
  • Ensure clear definition of the early clinical development plan (until transition) and clinical pharmacology plan, its milestones and, in particular, go/no go decisions and PoT deliverables, and ensure that the early clinical plan as well as the clinical pharmacology plan fits within the overall therapeutic area strategy;
  • Partner with other TMO functions for cost effective and optimal design, implementation and conduct of exploratory studies;
  • Be actively involved in interpretation of clinical and clinical pharmacology data and formulation data-driven development decisions, with full responsibility for all mentioned aspects;
  • Work independently with all TMO and SBU functions for developing, recommending, and adhering to the study budgets;
  • Provide input to and final review of, as well as the clinical approval for clinical documents: protocols, investigator brochures (IBs), Annual Program Reviews (APRs), study reports, statistical analysis plans, publications, clinical sections of Investigational New Drug (IND) / Clinical Trial Application (CTA) submissions;
  • Be responsible for expert panel meetings and advisory boards to give input into exploratory clinical and clinical pharmacology plans;
  • Present to senior management and external audiences on exploratory clinical and clinical pharmacology aspects of compound development, specifically milestones, strategies, and study results with conclusions and interpretation, of note the medical/clinical interpretation.

     

.pre {white-space: pre-wrap;} 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:

 

  • A highly successful M.D. or M.D.-Ph.D. with extensive professional and academic experience;
  • At least four years’ experience of exploratory clinical drug development and/or therapeutic specialty;
  • Significant experience in immuno-oncology;
  • Early clinical team membership experience;
  • Track record of designing, executing and delivering excellent, focused development plans and clinical studies, to produce both timely and good quality data;
  • Record of good managerial and leadership experience;
  • Proven ability to get results in a matrix management environment;
  • Very good knowledge of written and spoken English;
  • Track record of achievement and innovation in pharmaceutical medicine;
  • Demonstrated understanding of the complexities and recent developments in the medical area(s) germane to the Therapeutic Area (TA);
  • Understanding of issues related to the design and performance of technologically demanding trials;
  • Confident discussing scientific/mechanistic aspects of drug development;
  • Demonstrates ability to present clinical data, development plans and strategies clearly and accurately to relevant audiences;
  • Ability to manage clinical activities to milestones and budgets;
  • The ability to set a vision for the successful progression of drug candidates and inspire others to excel and constantly strive to succeed;
  • Must be a role model for behaviors consistent with the core values;
  • Set and revise goals, and measure team and individual performance;
  • Mentor team members to optimize both technical capability and personal effectiveness;
  • Able to relate broad exploratory development issues to the Research & Development (R&D) organization and facilitate evidence-based  governance decisions;
  • Constantly challenges existing paradigms in clinical research and encourages use of breakthrough designs based on an understanding of clinical methods, biomarkers and new technologies (including Pharmacokinetic/Pharmacodynamic (PK/PD) modelling and simulation, physiological measurements, imaging, and biochemical/drug assays).

 

Preferred Qualifications:

 

  • Significant experience in immuno-oncology at the translational level;
  • Experience with cellular therapeutics;
  • Command of a second major language.

 

 

#KRT

.pre {white-space: pre-wrap;} 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.