Director, Clinical Development

We are seeking a Director of Clinical Development to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on respiratory disease or immunology.

• Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, statistics, etc.) to support vital deliverables including the Target Medicine Profile (TMP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
• Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input (patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
• Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports, etc.
• Input to, and may lead, regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
• Provide medical monitoring and oversight of the safety of study participants.
• Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serving as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT), across internal matrix and a broad range of external experts (regulators, payors, CROs, consultants, investigators).
• Make significant contributions to global regulatory submissions/files (IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
• Evaluate specific business development activities, including due diligence and contribute to the implementation and embedding of strategic/organizational initiatives in Clinical Development, adopting innovative methodologies and processes including digital tools and technology.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK's competitive edge.

In addition to the above, you will:

• Demonstrate flexibility and adaptability in changing environments and ability to analyze incomplete information, identify potential risks and implications, and make informed decisions.
• Demonstrate enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.
• Embrace challenge as an opportunity, proactively generating ideas for innovative improvement and promoting an environment for others to be creative.
• Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
• Analyze, interpret and critically evaluate data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
• Consistently achieve desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.

• Bachelor's degree in a scientific field or Nursing.
• Experience in clinical research and drug development, including experience relevant to respiratory diseases or immunology.
• Experience in respiratory or immunology late-stage clinical development.

• Advanced Degree: MD, PhD, Pharm
  
  D.
• Medical degree with formal specialty training and board qualification/registration in Pulmonary Medicine, Pulmonary & Critical Care, Respiratory Medicine or Allergy/Immunology.
• Experience working in the global pharmaceutical or biotechnology industry within respiratory diseases or immunology.
• Experience leading global clinical trials and contributing to NDA, BLA, or MAA submissions.
• Experience in latestage respiratory or immunology drug development, including design, initiation, execution, and closure of Phase 2 and Phase 3 clinical trials.

• If you are based in Cambridge, MA;
  Waltham, MA;
  Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250.
• The position offers an annual bonus and eligibility to participate in a share based long term incentive program, dependent on the level of the role.
• Benefits include health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

If you require an accommodation or assistance to apply for a job at GSK, please contact the appropriate recruitment staff by emailing us at usre

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