Director Clinical Development (MD) - Switzerland
- Contract Type
Why work for my client?
- Be part of one of the most exciting biotech’s in the world specialising in Biosimilars
- Be part of a start-up environment with HUGE financial backing
- Have great exposure to regulatory agencies
- See products go through development to market in as little as 3 years
- Work alongside some of the industries most experienced and knowledgeable Biosimilars experts
- Be part of a company who are destined for great things
Overview: Lead clinical strategy/Clinical development plans for the dedicated compounds, leads and oversees the direction, planning and interpretation of clinical trials or research activities within therapeutic area via internal and external parties
- Manages the design and implementation of one or more clinical programs /clinical studies in support of an overall Clinical Development Plan, based on strong medical and scientific principles. May oversees CRO in terms of project-related education of investigators, study site personnel and study staff related to the medical elements. Responsibility may extend from early development activities to mature product lifecycle management
- Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall scientific strategy for internal and/or partnered programs including external regulatory interactions
- Has accountability and responsibility for oversight of the medical aspects of the clinical study including but not limited to medical monitoring, protocol deviations, data integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.
- Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures Clinical Study Reports, ISE, ISS, pediatric plans as needed
- Taking clinical leadership role in meetings with the regulatory organizations required to outline the Company position on research programs or regulatory applications.
- Leads as needed and 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 Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into protocols as appropriate.
- Is accountable and responsible for the medical elements within CRO selection and RFPs.
- Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the Biosimilars area.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Education: Medical Doctor (M.D.). Completion of a subspecialty fellowship is desirable.
Work experience: At least 5years of clinical development experience in the pharmaceutical industry preferably in biotechnology in a global role having lead compound(s) to submission and approval with key agencies.
Office based Switzerland / French region
Permanent / Full-time
Competitive salary plus benefits
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sam Chapple on +44 (0)203 868 8607 or e-mail on email@example.com
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
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