Sr Clinical Supplies Manager

**Job Title: Sr Clinical Supplies Manager**
**Location: Switzerland**

**Our Mission**:
**Summit Activities**:
We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule taking advantage of cooperative binding between the two. We initiated multiple phase-III clinical studies in the following Lung cancer indications:

- Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
- Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
- Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies._

**Overview Of Role**

We are seeking an experience clinical supplies professional to join the CMC team and support the supply chain strategy for clinical development and commercialisation preparations.

The Senior Clinical Supply Manager will be responsible for managing the planning and execution of assigned clinical supply projects and to support the ongoing development and optimization of Clinical Supplies department processes.

Travelling for the role (vendor facility visits, Investigator Meetings, etc) will be required at times and is estimated to be 5-10%.

**Roles and Responsibilities**
- **Clinical Trial Supply Planning and Forecasting**
- Develop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projections.
- Collaborate with cross-functional teams to ensure alignment of clinical trial supply plans with study timelines and milestones.
- **Vendor Management**
- Oversee relationships with external vendors, including clinical packaging and labelling partners, distribution centres, and courier services.
- Monitor vendor performance, adherence to timelines, and quality standards.
- **Inventory Management**
- Implement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chain.
- Ensure adequate and timely supply of investigational products to clinical sites.
- Oversee the planning, implementation and utilisation of effective clinical systems to support inventory management and distribution (e.g. IxRT).
- **Regulatory Compliance**
- Stay up to date on relevant regulatory requirements and guidelines related to clinical supply chain management.
- Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
- **Risk Management**
- Identify potential risks and challenges in the clinical supply chain and develop mitigation plans.
- Proactively address issues that may impact the availability of clinical trial materials.
- **Communication and Collaboration**
- Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Regulatory Affairs, Quality Assurance, and other relevant departments.
- Participate in project team meetings to provide updates on clinical supply chain status and address any issues or concerns.

**Experience, Education and Specialized Knowledge and Skills**
- Bachelor's degree in a relevant scientific or business discipline; advanced degree preferred.
- Minimum 5 years’ experience in Clinical Supplies management at a pharma, biotech or contract development and manufacturing organization (CDMO)
- Demonstrated track record of successfully managing complex international clinical studies and supply chains.
- Broad understanding of regulatory and GMP requirements for IMP product packaging and supply.
- Expertise in outsourcing and supplier management
- Proficiency with clinical supply planning and forecasting tools
- Demonstrated experience in building out an end-to-end product supply chain
- Comfortable interacting with all levels of the organization, customers, and suppliers
- Able to work with abstract global problems
- Nimble in a highly dynamic and agile organization where changing priorities are the norm
- Intuitive with well-honed interpersonal and communication skills
- Organized and demonstrates effective team leadership
- Effective with global workgroup associates
- A promotor of inclusion and collaboration
- Able to work independently
- Able to handle multiple projects simultaneously while maintaining high-quality results
- Capable of providing and implementing innovative solutions to unique and pressing situations
- Aware and compliant with FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCPs, Annex 13, and EU CT Directive
- Able to demonstrate a fundamental knowledge of drug dev