Clinical Development Medical Director - Neruology

• Provides effective support / oversight of R&D evidence generation activities to assure patient safety and study delivery.

• Contributes to the study team discussions on indication planning, incorporates input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to contribute to vital deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection. May assist clinical evaluation of business development opportunities

• Designs clinical development plans across all phases of development, and early phase study protocols, reflecting internal and external stakeholder input (e.g. patients, evidence generation, regulators, payors, pharmacovigilance)
• Develops clinical study protocols, amendments, investigator brochures, clinical study reports etc.
• Inputs to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
• Provides medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician. If physician, accountability for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

• Accountable for leading the clinical matrix team (CMT) on an EPU program. Serves as a clinical point of contact both internally and externally for an indication of an asset (i.e. PrePOC and single indication) or for a clinical study. Represents the clinical matrix team at early development team (EDT) or clinical study at CMT.
• Collaborates with cross-functional teams, including biology, translational, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive translational and clinical development plans. Act as clinical lead at study level.
• Actively leads the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as the primary point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
• Serves as the primary clinical interface with the relevant internal RIIRU/GSK review board (ie Technical Review or governance) and/or Protocol Review Board.
• Stays abreast of advancements in neurology and neurodegeneration research, clinical trial methodologies, competitive environment and regulatory space to maintain GSK’s competitive edge. Identifies and highlights transformational opportunity where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
• Consistently contributes to solving study and overall clinical development plan problems. Analyses, interprets and critically evaluates data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
• Contributes to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

• Primary medical qualification (MBBS or equivalent) and completion of Neurology specialty training (CCT and fellowship or equivalent level)
• Minimum of 3 years of experience in clinical research and development (may include postgrad experience)
• Robust knowledge of neurology specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
• Experience working with global regulatory agencies and managing global clinical trials in neurology.
• Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
• Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.

• In addition to Neurologist credentials, holding a higher research degree (e.g., PhD) or other demonstrable research expertise (e.g., Faculty appointments)
• Experience in contributing to NDA, BLA, or MAA submissions preferred
• Strong personal network across relevant scientific and clinical thought leaders, institutions and consortia in neurology

GlaxoSmithKline