(Senior) Director Clinical Development

The (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product.

Responsibilities

Design, conduct and report Sobi-sponsored studies in close collaboration with cross-functional teams.

Act as Study Physician responsible for clinical study synopsis, protocols, medical monitoring and statistical analysis plans.

Interact with key opinion leaders and patient representatives, lead advisory boards to define the clinical development strategy.

Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities.

Represent the clinical function in meetings with Health Authorities across multiple geographies.

Collaborate with global safety, medical affairs, scientific communications and business development functions.

Qualifications

Medical Degree with specialty in cardiology, lipidology, endocrinology or relevant clinical development experience.

+10 years global clinical development experience in the pharmaceutical industry.

Previous experience interacting with major Health Authorities and leading to drug approvals.

Expertise in translating early stage programs into the clinic and across the clinical development chain.

Strategic mindset, excellent communication skills in English and ability to represent the company to all audiences.

High medical, scientific and ethical integrity, results-oriented and proactive attitude.

Aligned with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.

Desired Attributes

At least 5 years clinical experience treating patients.

Excellent organizational skills, self-motivated and adept at managing projects in a fast-paced environment.

Ability to work independently, prioritize, and deliver business-critical items on time.

Strong interpersonal, cultural and communication skills across virtual environments.

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