Director of Clinical Development / Trial Design Lead / Clinical Evidence Principal

Role Description The Director of Clinical Development / Trial Design Lead / Clinical Evidence Principal leads the strategy, design, and generation of clinical evidence for investigational products, medical devices, diagnostics, or healthcare interventions. This role ensures that clinical-development programmes are scientifically rigorous, clinically relevant, operationally feasible, ethically sound, and aligned with regulatory, patient, and commercial objectives. The position works closely with Medical Affairs, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Safety, Quality, Translational Medicine, Biometrics, Commercial, and external research partners. Responsibilities include developing clinical-development plans, designing clinical studies and protocols, defining endpoints, assessing evidence gaps, reviewing emerging data, supporting investigator engagement, and guiding interpretation of clinical results. At leadership level, the role shapes evidence-generation strategy across the product lifecycle, oversees external clinical partners and expert advisors, and provides clear scientific input to senior governance forums. It ensures that clinical programmes meet good clinical practice and regulatory expectations, manage patient safety and delivery risks appropriately, and generate high-quality evidence to support development, approval, publication, and market access. Qualifications Medical degree, PhD, PharmD, master’s degree in Clinical Research, Life Sciences, Epidemiology, Biostatistics, Public Health, or a related field.Medical licence, specialist training, or relevant clinical qualification is advantageous where applicable.Significant experience in clinical development, clinical research, medical affairs, trial design, evidence generation, or a related field.Proven experience designing and developing clinical-study protocols, clinical-development plans, endpoints, eligibility criteria, schedules of assessments, and statistical considerations.Strong knowledge of clinical-trial methodology, study phases, randomisation, blinding, control arms, feasibility, patient recruitment, and clinical outcome assessments.Experience interpreting clinical, safety, biomarker, real-world, observational, or patient-reported-outcome data.Strong understanding of Good Clinical Practice, ICH guidelines, research ethics, informed consent, data integrity, patient safety, and applicable regulatory requirements.Experience working with regulatory authorities, ethics committees, investigators, key opinion leaders, clinical research organisations, and academic or healthcare partners.Ability to identify evidence gaps, assess scientific literature, develop evidence-generation strategies, and support publication or communication plans.Experience collaborating with biostatistics, data management, pharmacovigilance, regulatory, quality, and clinical-operations teams throughout trial delivery.Knowledge of clinical data standards, electronic-data-capture systems, clinical-trial management systems, and clinical documentation requirements.Experience supporting regulatory submissions, health-technology assessments, reimbursement evidence, product launches, or post-marketing evidence programmes is advantageous.Ability to manage clinical risks, protocol amendments, data-review processes, study governance, and cross-functional decision-making.Strong scientific writing, presentation, stakeholder-management, strategic-thinking, and problem-solving skills.High standards of scientific integrity, ethical judgement, attention to detail, and commitment to patient safety and quality.