Senior Director Clinical Development

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 (any phase as required by the clinical development program, including phase IV), clinical protocol development, medical monitoring of clinical trials, analysis of study data, contribution and review of clinical study reports, of clinical modules of registration dossiers, and of briefing books for interactions with Health Authorities.

The (senior) Director Clinical Development will represent and defend the clinical strategy during the MAA regulatory review process across multiple geographies and in meetings with Health Authorities. The individual will closely work with other RD functions to ensure the successful progress of projects and clinical trials and will interact with the scientific and patient community to ensure their insights are adequately incorporated in the clinical trials.

This position will require representing Sobi clinical development strategy externally as well as in internal meetings with senior management if required. Essential to success is a strong clinical development background with previous experience in late‑stage clinical trial design and conduct and in major regulatory submission (e.g. EU, Canada, Japan); excellent medical knowledge in lipidology and cardiovascular; ability to build and maintain strong relationships with study investigators/key opinion leaders (KOLs);

and ability to collaborate cross‑functionally.

• Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standards.
• Design, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other cross‑functional teams, as applicable.
• Act as study physician responsible for Sobi-sponsored studies if required: responsible for the development of clinical study synopsis and protocols, contribute to the statistical analysis plans, perform medical monitoring, participate in investigator meetings and other study‑related activities, and provide input/review of other main clinical study documents as needed and appropriate.
• Interact and consult with key opinion leaders and patient representatives, and lead advisory boards to define the clinical development strategy and inform the clinical trial design.
• Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities.
• Contribute with high‑quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority’s questions to support e.g., scientific advice, IND application, marketing authorization across multiple geographies.
• Represent the clinical function in meetings with Health Authorities.

Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on a specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.

• 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 and intimate understanding of translating early‑stage programs into the clinic and further across the clinical development chain.
• Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making.
• Demonstrated ability to build…