Director CLinical Development- Switzerland
- Contract Type
Ideal candidate will lead Strategic Clinical development plans, oversee the direction, planning and interpretation of clinical trials and research activities within therapeutic area
- Manages the design and implementation of one or more clinical programs and support an overall Clinical Development Plan.
- May oversees CRO in terms of project-related education of investigators, study site personnel and study staff related to the medical elements.
- Responsible for design, analysis, interpretation and reporting of scientific content of protocols
- Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall scientific strategy for internal and partnered programs
- Has accountability and responsibility for oversight of the medical aspects of the clinical study including protocol deviations, medical monitoring, data integrity and review, interpretation and communication of accumulating data.
- Taking clinical leadership role in meetings with the regulatory organizations required to outline the Company position on research programs or regulatory applications.
- Contributes to the data disclosure plans including publications before approval.
- Acts as a clinical interface and actively solicits opinion leader interactions related to the study; partners with other functions in these activities, consistent with corporate policies, to ensure that broad cross-functional perspectives.
- Stays abreast of professional information and technology with expertise in the Biosimilars area.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and to all other quality standards
- Medical Doctor (M.D.). Completion of a subspecialty fellowship is desirable.
- Minimum of 5years of clinical development experience in the pharmaceutical industry in a global role, having lead compound(s) to submission and approval with key agencies, preferably in biotechnology field.
About Planet Pharma
Planet Pharma was founded by a dedicated team of seasoned professionals with extensive experience supporting the pharmaceutical, biotechnology and device industries. Our goal was to create an organization that strengthens the employer-employee dynamic by connecting clients with talent — ultimately making staffing more personal and creating enduring, valuable relationships. We are able to achieve this by leveraging cutting-edge technology and flexible service delivery models that enable us to provide personalized solutions.
At Planet Pharma, the decision makers are at the table, with the tools and expertise to go beyond expectations. Our global Headquarters is located in Northbrook, IL and we have branch offices throughout the United States and Europe. All locations operate with shared attributes that are at the heart of everything we do:
Innovative – We constantly explore new ways of working that will help us be more efficient and effective Entrepreneurial – We look at things differently, immerse ourselves in your world and devise solutions for each and every client
Expert – Everyone on our team is an expert in their field, trained and continually learning to deliver an unrivaled level of experience
Passionate – We are all incredibly proud to be part of Planet Pharma and we genuinely care about the people we work with We provide the following solutions:
Contract Staffing, Outsourced Projects, Permanent Placement and Managed Service Provider Specialities: Clinical & Scientific Staffing, Technology Staffing, Site Management & Monitoring, Clinical Project & Program Management, Clinical Programming & Data Management, Biostatistical Analysis & Reporting, Pharmacovigilance, Medical Writing, Regulatory Affairs, Quality Assurance and Validation.
CHICAGO | SAN FRANCISCO | BALTIMORE | LONDON | RTP
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