Assoc Dir, Clinical Supply Integrator

Vor 5 Tagen

Zug, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson Innovative Medicine Supply Chain is recruiting for a(n) Associate Director, Clinical Supply Integrator, located in Zug, Switzerland.

Clinical Supply Chain (CSC) holds the responsibility of global clinical supplies of the Janssen Research & Development portfolio and the Global Medical Affairs portfolio. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product, Packaged and Labeled Clinical Supplies), demand forecasting, supply planning, and global distribution of supplies. Through a global network and organization, we are responsible for the clinical supplies of Synthetics, Molecules and Bio Therapeutics and Advanced Therapies products in development and low volume commercial supply and secure the supply to more than 60.000 patients in more than 330 clinical trials every year.

Key Responsibilities:
This matrix team leader leads the end-to-end supply chain management of clinical supplies.

Sets direction as the clinical supply chain project and team leader for one or more complex or accelerated compounds, from NME to Life Cycle Management.

Through the Clinical Supply Sub-Team, develops supply strategies matching needs of clinical programs and trials to ensure on time delivery and optimal supply for API, DP and Packaged materials.

For each compound, leads the monthly cS&OP cycle and takes leadership over the escalation and (as appropriate) resolution of critical risks and issues, including communication to key stakeholders.

Represents Clinical Supply Chain at the CMC team and the Clinical team leading the product strategy. Communicates and implements the strategy and development plan. Collaborates with the TAs, GDO, and DPDS to ensure translation of customer needs to fit-for-purpose.

Represents DPDS at the Clinical team, ensuring clinical strategy can be implemented. Influences the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction, and coordinates, escalates & communicates to the clinical team as needed.

Manages activities and budgets at a compound or trial level to meet key CSC/CMC/CT milestones.

**Qualifications**:
**Qualifications**:
**Education**:

- University/Bachelors Degree plus 8-12 years related experience. Or Masters Degree plus 6+ years related experience. Technical degree and/or experience a plus.

Experience and Skills:
Required:
Clinical supply design expertise (e.g., influencing clinical protocols, designing patient kits, developing distribution strategy) or equivalent (manufacturing, planning, supply chain, drug product development experience a plus) is required.

Excellent knowledge of CMC drug development process and roles or equivalent experience is required.

Experience communicating and implementing strategy / product development plan with high level of autonomy and accountability is required.

Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written and oral forms is required.

Experience leading late stage compound teams or multiple early projects for process development, tech transfer and regulatory filings is required.

Strong project execution and cross-functional coordination skills, able to build strong collaborative teams and relationships, leading cross functional/ virtual teams where required, contributes to employee engagement is required.

Experience interfacing directly with CMC/Tech team members, internal operations, Regulatory, JSC, external service providers and internal DPDS customers such as GDO and TA with limited or no guidance is required.

Experience influencing or persuading others to accept new ideas, approaches or concepts or gains alignment on divergent issues is required.

Experience managing a limited number of complex projects with potentially accelerated priority OR Leads complex Phase 3 clinical programs is required.

Advanced understanding and management of the E2E clinical supply budget, GXP principles, estimates and reporting is required.

Ability to work in a high-pressure environment, act with speed, flexibility, and accountability to achieve goals, solutions oriented, Integrity and Credo Based Actions is required.

Preferred:
Experience with the following functions: clinical supply chain packaging & distribution, clinical trial operations, project management, pharma/bio research and development, inventory management is preferred.

Experience with clinical supply demand management tools (e.g., IVRS, SAP, OMP+) is preferred.

Intermediate to advanced software skills (e.g., Microsoft Excel, OneNote, PowerPoint) is preferred

  • Assoc Dir, Clinical Supply Integrator

    Vor 2 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson Innovative Medicine Supply Chain is recruiting for a(n) Associate Director, Clinical Supply Integrator, located in Zug, Switzerland. Clinical Supply Chain (CSC) holds the responsibility of global clinical supplies of the Janssen Research & Development portfolio and the Global Medical Affairs portfolio. Our activities include all in-house...

  • Manager, Clinical Supply Chain

    vor 5 Monaten

    Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    This is an office-based role and will based in one of our offices located in Lexington, London or Zug. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. **Responsibilities **_(including, but not limited to)_**: - Ensure continuous supply of clinical trial material for assigned studies globally - Ensure on-time...

  • Manager, Clinical Supply Chain Mgmt

    vor 5 Monaten

    Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. **Responsibilities **_(including, but not limited to)_**: - Ensure continuous supply of clinical trial material for assigned studies globally - Ensure on-time startup of new studies by having supplies available as...

  • Sr. Clinical Project Manager/associate Director

    vor 5 Monaten

    Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    The Senior Clinical Project Manager/Associate Director, Clinical Operations will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the...

  • Mgr Supply Chain Transfer Mgmt

    vor 5 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    In this role, the Manager Supply Chain Transfermanagement represents all plan functions in the E2E Project team and is responsible and accountable for leading all plan aspects. The Manager SC Transfermanagement is the Global Planning leading contact to partner with the various functional areas (Local Operating Companies, Regulatory Affairs, Manufacturing...

  • Manager, External Manufacturing Operations

    vor 5 Monaten

    Zug, Schweiz Seagen Vollzeit

    **Manager, External Manufacturing Operations** Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer...

  • Supply Chain Manager

    vor 2 Monaten

    Zug, Zug, Schweiz IQVIA Vollzeit

    Job OverviewIQVIA is seeking a highly skilled and experienced professional to join our team as a Pharma Export and Import Specialist. This role will be responsible for coordinating and organizing the temperature-controlled transportation of national and international shipments.Key ResponsibilitiesCoordinate and plan shipping activities in close collaboration...

  • Sr Mgr, Global Npi

    vor 5 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    Innovative Medicine Supply Chain is recruiting for a Senior Manager - Global NPI and Launch Planning Process, to be located in Zug, Switzerland or any other EMEA location; Titusville, NJ or Horsham PA. As the Innovative Medicine division of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways...

  • Hospital Logistics Manager, Medtech Sc

    vor 5 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    **Hospital Logistics Manager, EMEA MedTech Supply Chain**: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine...

  • International Product Manager

    vor 2 Wochen

    Zug, Schweiz Roche Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Global External Manufacturing Director

    vor 5 Monaten

    Zug, Schweiz Galderma Vollzeit

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Manager, External Quality

    vor 5 Monaten

    Zug, Schweiz Pfizer Vollzeit

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Buhr, Emea Eth and Css

    vor 5 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    **BUHR LEADER - EMEA Ethicon & CSS** **Location: Zug, Switzerland - Birkerod, Denmark** **Contract: Full Time** **Johnson and Johnson, MedTech **has immediate opening for **BUHR Leader - EMEA Ethicon & CSS **which will be based in **Zug, Switzerland - Birkerod, Denmark **. **Overall, Purpose of this Job**: The **HR Leader, EMEA ETH & CSS Franchises is...

  • Buhr, Emea Eth and Css

    vor 5 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    **BUHR LEADER - EMEA Ethicon & CSS** **Location: Zug, Switzerland.** **Contract: Full Time** **Johnson and Johnson, MedTech **has immediate opening for **BUHR Leader - EMEA Ethicon & CSS **which will be based in **Zug, Switzerland.** **Overall, Purpose of this Job**: The **HR Leader, EMEA ETH & CSS Franchises is **responsible for two regional commercial...

  • Manager, QA Lifecycle Lead

    vor 3 Monaten

    Zug, Schweiz Apellis Pharmaceuticals Vollzeit

    **Overview**: The Manager Quality Assurance is responsible for providing the quality oversight of tech transfer and routine GMP batch production activities at our Contract Service Provider (CSP) located in Germany. The Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the support for the...

  • Emea Marketing Director- Sports

    vor 5 Monaten

    Zug, Schweiz Zimmer Biomet Vollzeit

    -Requisition Number EMEA10705 Employment Type Full-time Location Zug **What Is It Like To Work at Zimmer Biomet**: At **Zimmer Biomet**, we believe in **The Power of Us**, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. **Zimmer Biomet...

  • Emea Marketing Director- Sports

    vor 5 Monaten

    Zug, Schweiz Zimmer Biomet Vollzeit

    **Requisition Number**: EMEA10705 **Employment Type**: Full-time **Location**: Zug **What Is It Like To Work at Zimmer Biomet**: At **Zimmer Biomet**, we believe in **The Power of Us**, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and...

  • Senior Manager, Regulatory Affairs CMC

    vor 4 Monaten

    Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Description   The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Zug, Switzerland in the capacity of  CMC   Regulatory Affairs Senior...