Senior Director, Medicine Development Leader

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Leads the clinical development strategy for the designated compound(s) throughout the medicine lifecycle, from proof of concept to achieving successful global regulatory approvals/market access for various treatment indications.

• Offers clinical and scientific expertise to formulate and execute the asset strategy, enhancing project success.

• Collaborates with functional team members, TA head, and CAT Leaders to create Integrated Project Plans (IPP) documents.

• Identifies program risks alongside other functions and formulates mitigation strategies to address them.

• Communicates the nephrology clinical program to both internal stakeholders (including the CEO and the Executive Committee of the Organization) and external entities (Health Authorities, Steering Committees, Independent Data Monitoring Committees, and Patient Organizations, etc.), and engages with Key Opinion Leaders across different regions as needed.

• Serves as a core member of the benefit-risk team (BRT), regulatory submission teams, and the labeling working group.

• Ensures the endorsement of clinical development plans and study documents by Sobi governance bodies (e.g., Sobi Evidence Generation Board, Study Document Review Forum).

• Leads clinical scientists and the Medicine Development Team (which includes representatives from Medical Affairs, Clinical Science, Regulatory, Safety/PV, non-clinical/PK, Biostatistics/Data management, Clinical Program Management, Health Economics and Outcome Research, RWE, Program Management) within a matrix structure, providing strategic guidance and taking ultimate accountability for: Clinical trial design (clinical study synopsis and protocol development), planning (e.g., site and country selection), execution (e.g., medical monitoring, resolution of safety issues; interpretation of statistical analyses), and internal and external communication of study results.

• Develops clinical components of essential documents (Clinical Development Plans, Clinical Study Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, Clinical Modules of registration dossiers, Briefing Books for interactions with Health Authorities) ensuring high quality and consistency with the Integrated Project Plan and Target Product Profile.

• Provides necessary input on clinical efficacy, safety, dosing/administration, mechanism of action, and more for the Target Product Profile (TPP) and supports registration and market access (Core Data Sheet, Development Safety Update Report, Periodic Safety Update Report, clinical benefit-risk assessment) while collaborating with the Regulatory team to establish an international submission strategy.

⛳️ Requirements

• Medical degree with over 10 years of pertinent clinical experience in academic and/or pharmaceutical Global Research & Development roles.

• Proven history in drug development programs, ideally within nephrology.

• Extensive understanding of clinical trial methodology, global regulatory requirements, and experience in the design and execution of clinical studies.

• Advanced knowledge of clinical trial operational aspects, including budget and timeline management.

• Demonstrated ability to develop and execute strategic and tactical plans.

• Experience in engaging with key internal and external stakeholders.

• Expertise in the relevant therapeutic area with at least 5 years of clinical experience treating patients and successful interactions with major Health Authorities leading to drug approvals.

• Strong leadership abilities with a proven capacity to lead cross-functional teams in a matrix environment.

• Ability to coach, mentor, and communicate effectively with all audiences, both internally and externally.

• Excellent organizational skills with a self-motivated drive to implement best practices.

• Proven ability to evaluate and analyze medical and scientific literature.

• Fluent in written and verbal communication in English.

🏝️ Benefits

• All your information will be kept confidential according to EEO guidelines.