Senior Medical Director, Clinical Development (m/f/d)

Coopers Group AG; Basel-Stadt; Vor Ort; CHF 120’000 - 170’000; Vollzeit

Zusammenfassung

A leading clinical research organization is seeking a motivated individual for a role in clinical development in Basel, Switzerland. Responsibilities include supporting clinical study planning, managing and executing clinical trials, and ensuring compliance with regulatory requirements. The ideal candidate will hold an MD and have over 8 years of experience in clinical drug development. Strong leadership skills and a deep understanding of clinical research methodologies are essential for this position. This role offers a dynamic environment to impact clinical research outcomes.

Qualifikationen

• MD and 8+ years of experience in clinical drug development.
• Proven experience in registration-track global clinical trials.
• Substantial experience as a principal investigator for industry-sponsored trials.
• Knowledge of regulatory requirements and clinical trial protocols.
• Experience interacting with ethics committees and regulatory authorities.

Aufgaben

• Support overall clinical and scientific activities for study planning and management.
• Create clinical development strategy and Clinical Development Plan (CDP).
• Lead preparation of key study documents and ensure data quality.
• Assess logistics and execution of clinical research aligned with the strategy.
• Participate in interactions with regulatory agencies.

Kenntnisse

Leadership skills

Clinical research methodology knowledge

Data analysis

Regulatory requirements knowledge

Ausbildung

MD

Thorough experience in clinical drug development (8+ years)

Jobbeschreibung

Stellenbeschreibung

Contract Duration: 1 year/possible extension

Location: Basel

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.