Clinical Program Leader

Vor 7 Tagen

Basel, Schweiz Sobi Vollzeit

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**

**Clinical Program Leader**:
**Role & Function**
The Clinical Program Leader (CPL) leads and manages the cross-functional clinical program team, and ensures delivery of clinical activities to agreed timelines, budget and quality for the program. The CPL ensures that a clinical strategy is developed and implemented, and provide strategic and operational clinical development expertise to the project/product program development team.

To secure an effective utilization of internal and external resources, a large part of clinical study activities are executed by external service providers

**Key Responsibilities**
- Ensure development and implementation of an innovative and effective clinical strategy for programs- Ensure knowledge of the patient´s medical need, current clinical landscape and operational feasibility by building relationships with key opinion leaders, investigators, patient organizations, other external parties and Sobi affiliates
- Lead and manage the cross-functional clinical program team and supervise that the objectives and responsibilities within the team are fulfilled and present clinical strategies, activities and deliverables internally as well as externally- Provide strategic and operational clinical development expertise at meetings with e.g., key opinion leaders, patient organizations, regulatory authorities, and pricing and reimbursement authorities- Contribute to the writing of publications and abstracts, in accordance with the publication strategy- Ensure that all clinical strategies, activities and deliverables are compliant with Sobi SOPs, ICH/GCP guidelines, GPP guidelines and regulatory requirements- Contribute to the development of processes and tools to continuously improve resource utilization and quality of clinical strategies, activities and deliverables- May assume a Clinical Study Manager role within a clinical program**Qualifications**
- University degree in Life/Health Sciences- A minimum of 10 years' experience of planning, conducting and reporting multicenter, international clinical studies- Extensive experience of developing and implementing clinical strategies for drug development programs- Experience of budget and resource forecast and management- Experience of managing external service providers (ESPs)- Experience of NDA/BLA and/or MAA- Experience from head quarter, affiliate and contract research organisation**Personal attributes**
- A high level of proactivity, commitment and energy, good influencing skills, excellent problem solving skills
- Strong individual initiative, organizational skills, and multi-tasking abilities
- Strong customer-oriented mindset
- A flexible and "can do" attitude

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 Basel, Switzerland.

**Reporting to**
VP, Head of Clinical Program Management

**Recruitment contact & how to apply**
For questions contact HR responsible for this recruitment Maria Hebert-Carrillo

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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