For our Swiss customer located in Basel we are currently looking for (m/f) an Clinical Scientist for iPODD pediatric oncology team - PHARMA
- Type of placement: 15 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 2, please ask us for the exact rate range
PHARMA: (monthly gross salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
The iPODD team is responsible for the clinical development of the late stage oncology prtfolio for children with cancer. The iPODD CS teams consists of 10 members (CS and medical directors) which together have the responsibility for the active clinical development of 6 molecules in children, ranging from first-in-child ph1 studies to ph2 signal-seeking and pivotal trials and filings.
The contractor CS will be take over the responsibility for 2 molecules in active ph1/2 development, both at the SMT (study management team) level and the GDT (global development team) level in close collaboration with the medical monitor of our team. The main activities of this position will be contributing to SMT discussions on trial protocol and patient data, responding to site/monitor queries, assessing protocol deviations, reviewing and querying study data, leading discussions in investigator calls, authoring protocol amendments, contributing to PIP modifications, responding to health authority questions, liaising with external CROs in relation to ongoing study activities, preparation and presentation of data/information at various study level (eg IDMC and CSR) and strategic level meetings (GDT updates, life cycle team meetings, investigator meetings), abstract preparation for upcoming congress.
Furthermore, it is expected that during the contract period also new molecule projects with CD plan development and protocol writing could be started.
Our customer's Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - IIIA) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Clinical Scientist participates in development of the Clinical Development (CD) strategy and plan and supports the assigned PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s).
PD Clinical Scientists have primary responsibilities for supporting PD Medical Directors/Clinical Development Physicians with clinical documentation, representing PD Clinical Scientist CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/ safety data reviews, and providing clinical science inputs into study reporting. PD Clinical Scientists are expected to perform their responsibilities independently. PD Clinical Scientists are likely to have regular external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc. They may also, alongside the PD Medical Director/Clinical Development Physician, participate in external interactions with health authorities (HAs).
PRIMARY DUTIES AND RESPONSIBILITIES:
- 1. Cross-Functional Team Leadership & Management
- 2. Global Clinical Development Planning
- 3. Clinical Development Plan Implementation
- Bachelors Degree required (life sciences preferred)
- Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
- 8 or more years clinical trial experience (must demonstrate a minimum of
- 4 years clinical trial experience in pharma/biotech industry)
- Data listing review experience
- Experience working on a clinical team (or equivalent)
- Experience authoring aspects of a global clinical development plan or full clinical study protocol
- Experience publishing results of a clinical drug trial in a referred journal
- Strong relevant therapeutic area experience (typically demonstrable with 2 or more years relevant experience)
- Has extensive knowledge of clinical research and has successfully worked across Phase II - III drug development projects
- Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- Well-versed in medical aspects of GCP (Good Clinical Practice),
- ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
- Previous people management experience is a plus