Clinical affairs manager Jobs in Wetter (Hessen)

Description

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Director of Clinical Portfolio Execution? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. It is a Hybrid role. You will have multiple direct reports. You will report to the Senior Director of Clinical Portfolio Execution.

Responsibilities :

You will establish and manage standards and processes for main study operations activities (e.g., clinical trial support, clinops human biological sample management).

Facilitate global resourcing for clinical portfolio execution roles to support the Head, CPE in ensuring appropriate and resource allocation aligned with project priorities. In collaboration with Business Operations, includes demand planning and utilization across all programs. Ensure there is a communication strategy laterally and vertically for resource management and utilization.

Utilize lessons learned from prior study conduct, site visits, audits, and inspections to develop and implement process improvements. Collaborate with Operational Excellence and Clinical Compliance to ensure CSL expectations adhere to ICH GCP guidelines and industry best practices. Manage framework / standardized tools that enable best practice approach.

Lead CPE capability building by supporting onboarding. Ensure Harmonization of practice at study level, to ensure consistency, high quality, and efficiency.

Set-up and make the interface with any Functional Service provider for study delivery activities. Ensure oversight of vendor activities including FSO. May contribute to train FSP staff on CSL expectations.

Responsible for quality practices, management monitoring, control documents development, improvement support and training related to Study Delivery roles People Management

Experience

A Bachelor’s degree in Science or Pharmacy.

12 or more years of relevant clinical research (or related) experience in the pharmaceutical industry.

An understanding of the drug development process, and specifically, each step within the clinical trial process.

Experience in study management, clinical-ops, human biological sample management and related process development.

Knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives.

• LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.