Clinical Development Director

Basic qualifications: 

Medical degree with UK General Medical Council (GMC)/US Board Certification or equivalent status required, along with recent relevant therapeutic experience. 
Expertise in nephrology, transplantation or rheumatology is strongly preferred.  
Either pharmaceutical experience in a related field or an academic higher qualification (i.e. PhD) is preferred.

Preferred qualifications: 

Either pharmaceutical experience in a related field or an academic higher qualification (i.e. PhD) is preferred

Details: 

Clinical Development Director, Benlysta



   The Late-Phase Clinical Team comprises physicians and scientists delivering novel and transformational medicines to treat immunoinflammatory conditions. Joining our Benlysta clinical team you will be accountable for the provision of globally integrated medical governance and clinical leadership of a clinical trial, and successful delivery of the trial according to quality standards, timelines and budget measures.

The key elements of the role are to provide:
• Clinical leadership and disease area expertise in the conduct of new indication or post-approval commitment studies for Benlysta 
• Single point of accountability for the Medical Governance of the clinical trial with a global viewpoint of safety and efficacy
• Leadership of cross-functional study teams
• Input to trial design, protocol development and medical aspects of the study conduct 
• Medical monitoring of the trial to ensure subject safety and appropriate detection and management of safety related issues
• Active contribution to GSK Safety Review Team and Clinical Matrix Team 
• Medical point of contact on behalf of GSK (sponsor) for external vendors, GSK Local Operating Companies, and that investigators of the clinical trial
• Key liaison with external regulatory agencies and external experts
• Input to Integrated Evidence Generation plan and market access strategy

Additional Skills required:
- Must have strong drug development knowledge and experience: experience in the design, execution, statistical analysis, reporting and data interpretation of clinical studies.
- Therapy area expertise and experience in biopharmaceutical development in immune-mediated diseases (e.g. rheumatology, nephrology or immunology) preferred
- Strong Leadership skills: self-awareness, drive performance, work across boundaries, coach and mentor team(s) and  ability to execute the assigned role(s) in a global matrix and line environment
- Driving a disciplined approach to clinical research by ensuring a relentless focus on quality, compliance, scientific rigour and operational excellence
- Scientific Writing: ability to produce written communications with clarity, accuracy and rigour
- Excellent communication and presentation skills: ability to communicate effectively with credibility, accuracy, and confidence with internal and external stakeholders and experts.
- Discipline of forward planning, organising and managing resources to successfully deliver the goals 


                                                                    Location:        Stockley Park, Stevenage or Philadelphia based, 

                                                                     Please use the cover letter to highlight how you meet the competencies required for the role. Your cover letter along with CV will be used to assess your application.


                                                 Closing date Closing date 13th October 2016                                                                                                                                                         *LI-GSK

Contact information: 

You may apply for this position online by selecting the Apply now button.