Senior Medical Director Clinical Development

As Senior Medical Director, Clinical Development you will be a key member of the interdisciplinary development team, contributing effectively and independently to clinical development of assigned assets. This is a high visibility leadership role directly reporting to the Head of Clinical Development, Basel Site. You will lead clinical development activities relating to the design, execution, and interpretation of clinical trials and the clinical development plan. You will work with the study management teams, training internal and external staff, monitoring clinical data, and responding to health authority requests related to the assigned clinical development activities.

The successful candidate will integrate clinical and research expertise with leadership skills to advance clinical development strategy

Responsibilities:

You will be responsible for supporting the overall clinical and scientific activities regarding study planning preparation, management, evaluation, monitoring and documentation. In the role you will:

• Participate and lead clinical development, both as individual contributor and leader
• Create and guide clinical development strategy and formulate Clinical Development Plan (CDP), may be leading cross-functional team to evaluate and integrate regulatory, safety, and timeline considerations.
• Lead and contribute to preparation of key study documents, including but not limited to study protocols and amendments, statistical analysis plans, clinical study reports, regulatory filing documents.
• Lead and contribute to sponsor oversight of clinical trial execution, ensuring data quality and subject safety through trial medical monitoring or medical oversight of the studies and CROs. Assess impact of results on the development strategy, and present conclusions to management.
• Interactions with external stakeholders: Assess and support the logistics and execution of clinical and preclinical research aligned to the clinical development or medical affairs strategy, including external research collaborations and investigator-initiated research. Support the scientific communication and publication strategy. Participate in interactions with regulatory agencies, such as reporting requirements (e.g., DSUR, INDSRs, etc.) and regulatory submissions.

Requirements:

The successful candidate will be a highly motivated self-starter with strong leadership skills who thrives on working in a team environment, applies independent thought and creativity in programs or projects, and skillfully influences and holds others accountable in achieving team goals:

• Education: MD
  and eight or more years of experience in clinical drug development.
• Proven experience in design, conduct and data analysis of registration-track global clinical trials. Experience designing and conducting rare disease clinical trials is strongly preferred.
• Substantial experience as an academic principal investigator for industry-sponsored trials can be considered.
• Knowledge of regulatory requirements governing clinical trials and extensive experience in development of and writing of registration-track clinical trial protocols plus other trial related documents.
• Experience in interactions with ethics committee, regulatory authorities and other external agencies.
• Previous experience in providing oversight to vendor activities including CRO Preferably board certified (or foreign equivalent) in Gastroenterology and/or Hepatology, Internal Diseases or Pediatrics, but candidates with backgrounds in with other medical specialties who have sound clinical research experience will be considered
• Proven knowledge of clinical research methodology and biostatistics principles, Ability to analyze and interpret clinical and efficacy data and develop formal written reports and presentations of those data internally and externally.