Scientific Director, Clinical Development, Respiratory

Role Overview

• Provide clinical and scientific leadership for potential new, established, and emerging indications for assets in clinical development with a strong focus in respiratory disease.
• Work with project teams to plan and ensure delivery of clinical research and development activities and establish efficient collaboration throughout all stages of development.
• Report to the Vice President, Clinical Research Head, Respiratory.
• Lead the clinical development strategy from a drug or program including accountability for the clinical components of the Target Medicine Profile (TMP) and leadership of the clinical matrix team (CMT).
• Ensure cohesive and comprehensive clinical development plans (CDP) for product(s) and/or indication(s).
• Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
• Contribute to the development of the Integrated Evidence Strategy (IES), including oversight of the CDP and its component clinical trials.
• Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and programs, providing strategic leadership in assuring that clinical study designs are aligned with the IES and CDP.
• Drive ambitious and achievable clinical development timelines, incorporating key decision points, risk and cost analyses, and Go/No Go criteria.
• Lead and be accountable for the evaluation of the probability of technical success (PTRS) of clinical studies/programs.
• Assess risk/benefit at the study and/or project level and take action to mitigate risk where appropriate.
• Nurture and maintain relationships with counterparts in Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics.
• Serve as a clinical point of contact for senior management and senior level matrix teams, across the internal matrix and positively interface and influence a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators).
• Lead clinical development discussions and teams at global regulatory interactions.
• Make substantial contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
• Manage technical and leadership development of Clinical Development staff via direct line management, mentoring and coaching across the organization.
• Manage and contribute to the development of strategic initiatives, specific business development activities including due diligence, and organizational initiatives in Clinical Development, championing innovative methodologies and processes including digital tools and technology, encouraging others to think differently and adopt new ways of working.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge.
• Excel in ambiguous situations by demonstrating strong problem-solving skills and innovative thinking.
• Anticipate potential challenges, develop strategic approaches, and effectively communicate uncertainty to stakeholders while guiding teams through unclear circumstances.
• Adept at identifying opportunities for synergy and innovation across the organization and influencing others to adopt an enterprise mindset.
• Use strategic thinking to analyze, interpret, and critically evaluate complex data and information.
• Anticipate obstacles and identify innovative solutions to ensure timely delivery of evidence that supports regulatory approvals and patient benefit.
• Skilled in understanding individual motivations and tailoring approaches to team members to drive commitment, a strong track record of inspiring and leading others to achieve exceptional results.
• Navigate ambiguity by anticipating regulatory challenges and proactively addressing issues.

Requirements

• Advanced Degree Required: PhD or PharmD
• Experience in Respiratory clinical research and development, may include postgrad experience.
• Experience contributing to or leading a global clinical development program in the biopharmaceutical industry.
• Medical degree preferred
• Proven track record of successfully leading cross-functional teams and executing industry sponsored clinical trials.
• In-depth knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
• Demonstrated ability to work independently to design trials to regulatory standards from concept to completion.
• Demonstrated leadership/People Management experience in clinical practice, academia and/or industry, leading line and matrix teams with a reputation of inspiring and motivating high performance
• Experience working with global regulatory agencies and managing global clinical trials in respiratory disease
• Experience in setting and executing scientific strategy preferred.
• Experience in translational medicine preferred.
• Experience in leading NDA, BLA, or MAA submissions preferred

Tech Stack

• Google Cloud Platform
• Go

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave