Medicine Development Leader

vor 5 Monaten

Home Office, Schweiz Sobi Vollzeit

**Role & Function**

The Medicine Development Leader has the overall responsibility for bringing and representing the clinical and the medical strategy for the assigned product to the Core Asset Team (CAT), including benefit / risk evaluation, PV and Safety.

**Key Responsibilities**
- Provides medical and scientific expertise and perspective to inform asset strategy and strategy execution and optimize project success
- Works with functional members and Core Asset Team (CAT) Leaders to develop Integrated Project Plans (IPP) documents
- Identifies risks and challenges for the program and interdependencies with other functions and develops mitigation strategies to address them
- Provides input on clinical efficacy, safety, dosing / administration, mechanism of action, etc. for Target Product Profile (TPP)
- Presents the assigned clinical programs to internal (including the CEO and the Executive Committee of the Organization) and external stakeholders (Health Authorities, Steering Committees, Independent Data Monitoring Committees, and Patient Organizations), engaging when necessary with Key Opinion Leaders across geographies
- Leads the Medicine Development Team (including representatives from Medical Affairs & Clinical Science (MACS), Medical Excellence, Safety/PV, PDTM, Biostats/Data management, Clinical Program Management, Regulatory, HEOR) ensuring:

- The development, planning and execution of the clinical trial strategy for successful global regulatory approval/market access for multiple treatment indications
- The development, planning and execution of the Medical Affairs strategy incl. Medical Plan and Integrated Evidence Generation Plan
- The creation of clinical components of key 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) with high quality and consistency with the Integrated Development Plan and Target Product Profile.
- Adequate support to registration, market access, and commercialization (Core Data Sheet, Development Safety Update Report, Periodic Safety Update Report, clinical benefit-risk assessment) for the assigned compounds
- Collaboration with Regulatory team to determine international submission timelines
- Definition of the medical value story and provision of clinical trial evidence for input to Patient Access Plan

**Qualifications**
- Medical Degree
- Relevant clinical experience in the academic setting and in the Pharmaceutical Industry within Global R&D roles (+10 years)
- 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 and execute strategic and tactical development and medical plans
- Experience and ability to engage with key internal and external stakeholders
- Specialty in the relevant therapeutic area with at least 5 years clinical experience in treating patients
- Successful interactions with major Health Authorities leading to drug approvals
- Experience in international Launch

**Personal attributes**
- Strong leadeship skills with demonstrated capability to lead cross-functional teams
- Excellent communication skills, capable of representing the company to all audiences both internally and externally, particularly in the context of collaborations at international conferences and scientific symposia
- Excellent organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operations
- Demonstrated ability to accurately and effectively evaluate and analyse medical/scientific literature
- Excellent written and verbal communication skills in English
- Able to demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.
- Collaborative team player with interpersonal skills, able to work effectively in a team setting and interact respectfully with people of different cultural, seniority and functional backgrounds
- Results oriented with a can-do attitude - Sense of accountability and ownership - Entrepreneurial, driven and engaged - High medical, scientific and ethical integrity
- Flexible and able to operate in a quickly changing environment
- Strong attention to detail
- Able to work independently
- Prioritization and time management skills In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**

The position will be based in Switzerland or Sweden #Li-remote

**Reportin

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