(Senior) Director Clinical Development

Company Description

(Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and registration dossiers, briefing books for Health Authority interactions. The Director represents and defends the clinical strategy during MAA regulatory reviews across multiple geographies and in meetings with Health Authorities. The individual works closely with other RD functions to ensure successful progress of projects and clinical trials and interacts with the scientific and patient community to incorporate their insights. The position requires representing Sobi clinical development strategy externally and internally. Essential to success is a strong clinical development background with late‑stage trial design and conduct, experience with major regulatory submissions (EU, Canada, Japan), excellent medical knowledge in lipidology and cardiovascular, the ability to build relationships with investigators/KOLs, and cross‑functional collaboration.

Responsibilities

• Shape and develop clinical development plans while adhering to the highest scientific and ethical standards.
• Design, conduct and report Sobi‑sponsored studies in close collaboration with the clinical development team, clinical study teams, regulatory, safety and other cross‑functional teams.
• Act as Study Physician responsible for Sobi‑sponsored studies if required: develop study synopsis and protocols, contribute to statistical analysis plans, perform medical monitoring, participate in investigator meetings and provide input on other main clinical study documents.
• Interact and consult with key opinion leaders and patient representatives, and lead advisory boards to define clinical development 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 delivery of clinical parts of submissions and other regulatory documents, and respond to Health Authority questions to support scientific advice, IND application, marketing authorization across multiple geographies.
• Represent the clinical function in meetings with Health Authorities.

Experience / Competencies – Required

• Medical Degree.
• Specialty in cardiology, lipidology, endocrinology or relevant previous clinical development experience (+7 years) in these therapeutic areas.
• Relevant global clinical development experience in the pharmaceutical industry (+10 years).
• Previous experience in interactions with major Health Authorities.
• Solid record of accomplishment in drug development programs within the relevant therapeutic area demonstrating outstanding understanding of translating early‑stage programs into the clinic and beyond.
• Expertise in bringing the medical and scientific perspective to business development, corporate strategy and leadership decision making.
• Demonstrated ability to build and execute strategic and tactical development and medical plans.
• Experience and ability to engage with key internal and external stakeholders.

Experience / Competencies – Highly Desired

• At least 5 years clinical experience in treating patients.
• Successful interactions with major Health Authorities leading to drug approvals.

Skills / Languages – Required

• Excellent communication skills, capable of representing the company to all audiences internally and externally.
• Strategic mindset.
• Excellent organizational skills, self‑motivated driver of best practices and processes in project and operations management.
• Excellent written and verbal communication skills in English.
• Able to demonstrate behaviours in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.

Personal Attributes – Required

• Good team‑player, able to work effectively in a team setting and interact respectfully with people of different cultural, seniority and functional backgrounds.
• Highly flexible and comfortable working in a fast‑paced and quickly changing environment.
• Able to work well in a virtual environment; proven self‑management by showing initiative, good organisation and willingness to be held accountable.
• Results oriented with a can‑do and proactive attitude.
• High medical, scientific and ethical integrity.
• Able to prioritise.

Additional Information

• Driven, flexible and with strong team working and project management skills.
• Strong interpersonal, cultural and communication skills.
• Analytical, with a problem‑solving and collaborative mindset.
• Forward‑looking mindset, to ensure that our PV ESP systems and operations environment is continuously developed to ensure ongoing compliance and to deliver high‑quality and cost‑effective outcomes.
• Strong ability to work independently and to make priorities to deliver business‑critical items in time.
• Demonstrate the Sobi Values: Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.