Company Description
The (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include design of clinical trials across all phases (including phase IV), clinical protocol development, medical monitoring, analysis of study data, and contribution to clinical study reports, registration dossier modules and briefing books for Health Authority interactions.
The Director will represent and defend the clinical strategy during regulatory review processes (MAA) across multiple geographies and in meetings with Health Authorities. The role requires close collaboration with other research and development functions, scientific and patient communities to incorporate their insights into the trials.
This position also involves external representation of Sobi’s clinical development strategy and internal discussions with senior management when required.
Job Description
* Shape and develop clinical development plans while maintaining the highest scientific and ethical standards.
* Design, conduct and report Sobi-sponsored studies in collaboration with the clinical development team, study teams, regulatory, safety and other cross‑functional teams.
* Act as study physician for Sobi-sponsored studies: develop study synopsis and protocols, contribute to statistical analysis plans, perform medical monitoring, participate in investigator meetings and review other key clinical documents.
* Interact with key opinion leaders and patient representatives, lead advisory boards to define clinical strategy and inform trial design.
* Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities.
* Contribute high‑quality scientific and medical input to regulatory submissions, responses to Health Authority questions, and support scientific advice, IND applications and marketing authorisations across multiple geographies.
* Represent the clinical function in meetings with Health Authorities.
* Provide scientific and medical support to other functions (global safety, medical affairs, scientific communications, business development) as needed.
Qualifications
Experience / Competencies
Required
* Medical Degree.
* Specialty in cardiology, lipidology, endocrinology or relevant prior clinical development experience (+7 years) in these therapeutic areas.
* 10+ years of global clinical development experience in the pharmaceutical industry.
* Prior interaction with major Health Authorities.
* Strong record of accomplishment in drug development programs within the relevant therapeutic area.
* Expertise in translating early‑stage programs into clinical and regulatory milestones.
* Ability to develop strategic and tactical clinical plans.
* Proven stakeholder engagement skills.
Highly Desired
* At least 5 years clinical experience treating patients.
* Successful interactions with major Health Authorities leading to drug approvals.
Skills / Languages
Required
* Excellent communication skills; able to represent the company to all audiences.
* Strategic mindset.
* Excellent organisational skills; self‑motivated and proactive.
* Excellent written and verbal communication in English.
* Alignment with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.
Personal Attributes
Required
* Good team player with respect for diverse cultural and functional backgrounds.
* Highly flexible and able to work in a fast‑paced, rapidly changing environment.
* Self‑managed, proactive, and accountable in virtual settings.
* Results‑oriented with a can‑do attitude.
* High medical, scientific and ethical integrity.
* Strong prioritisation skills.
Additional Information
* Strong teamwork, project management, interpersonal and communication skills.
* Analytical, problem‑solving and collaborative mindset.
* Forward‑looking mindset to continuously improve PV ESP systems and operations.
* Independent, prioritising business‑critical items to deliver on time.
* Demonstrates Sobi values across all interactions.
Seniority level
* Director
Employment type
* Full‑time
Job function
* Science
Industries
* Pharmaceutical Manufacturing
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