Arbetsbeskrivning

Role summary

The Clinical Expert/Clinical Study Physician will provide medical leadership and oversight for clinical trials in patients primarily with a central nervous system (CNS) disorder. The role is responsible for strategic and operational medical aspects of assigned clinical development projects, study designs, sponsor safety surveillance and adjudication of clinical events, communication with investigators, health authorities, ethics committees, and potential other committees relating to study conduct. The role is also required to support regulatory safety reporting as applicable.

The physician will work closely with Clinical Operations, Biostatistics, Biomarkers/Imaging experts in the Research Organization and Regulatory team members to ensure high-quality, GCP-compliant study design and conduct and the timely delivery of medically informed decisions. Close co-operation with the medical monitor and other relevant members of the CRO team deployed to conduct the study will be a further critical aspect of the daily work. The role will also provide updates on study progress and report data to relevant project and leadership teams in the company and as applicable present data at scientific congresses.

The role is expected to ensure high quality medical leadership and expert input for Early Project Teams to ensure that Target Product Profiles and Early Clinical Plans for Research projects are based on medical insights on unmet medical needs as well as emergent scientific developments in the field.

Key responsibilities

• Ensure high quality strategic and operational leadership and expert input to assigned clinical development projects.

• Contribute to/be responsible for clinical study design, informed consent forms, investigator brochures and study manuals with specific indication-relevant medical input.

• Provide day-to-day medical oversight of the assigned clinical studies.

• Review and adjudicate adverse events, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs); support preparations of regulatory safety reports and aggregate safety analyses.

• Establish and maintain study and program safety management and medical monitoring plans, escalation pathways and Risk Evaluation and Mitigation Strategy actions as required.

• Provide medical input to investigator training and investigator meetings; answer medical queries from sites and global study teams.

• Support regulatory interactions and responses to health authorities on medical/scientific issues related to the study.

Qualifications

Required:

• Medical degree, specialist in neurology and PhD is preferred.

• At least 5 years clinical experience including treatment of subjects with CNS disorders e.g. neurology, psychiatry, or internal medicine.

• At least 5 years experience in a Pharmaceutical Company as a Study or Program Physician with responsibility for on-going clinical trials, preferably in neurology indications.

• Demonstrated knowledge of ICH-GCP, SAE reporting requirements and clinical trial regulatory environment.

• Strong written and verbal communication skills in English.

Preferred:

• Experience from leadership responsibility of clinical development programs in pharma development.

• Prior experience as a Clinical investigator.

• Experience with CNS-specific outcome measures, neuropsychological testing, imaging endpoints (MRI, PET) and biomarker interpretation.

• Experience interacting with Data Safety Monitoring Boards and writing medical sections of regulatory submissions (IND/CTA).

• Experience with electronic data capture systems and medical review workflows.

Core competencies

• Clinical judgement and rapid decision-making on patient safety.

• Leadership of clinical development teams.

• Clear, concise scientific and medical communication including in writing.

• Cross-functional collaboration and stakeholder management.

• Ability to interpret complex clinical and biomarker data.

• Ethical conduct and adherence to regulatory and GCP standards.

Reporting

Reports to the Head of Clinical Development and Regulatory Affair.

Works closely with colleagues in Clinical Development and Regulatory Affairs, as well as project leaders in Research & Development and other functions.

Working conditions

• Full time position: expected on-site work at least 3 days/week.

• Flexible hours to support global trial teams across time zones when needed.