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| Clinical Research Scientist - Oncology |
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To provide scientific expertise to development, design, conduct, and analysis of POC clinical trials/projects in accordance with Clinical Development plans agreed by the Project Team.
To contribute to and review trial related documentation such as eCRF, informed consent form, medical/statistical supervision plan, SAE reports, Investigational Brochure and Annual Safety Report updates, biomarker and pharmacogenomics plans, Gather the appropriate medical expertise within or outside the GEDU Oncology in order to provide support/input to business development activities and early development projects. Act as a scientific expert for the GEDU Oncology to ensure up-to-date knowledge in the fields related to the therapeutic area and all techniques (including biomarker assays and imaging) and outcome measures used in the Clinical Development plans. Contribute to assessments of preclinical research programs, together with the GEDU Head and Deputy, if needed. Support the GEDU Head and Deputy in communication and alignment matters between Non-clinical Research and Clinical Development.
Key Tasks and Responsibilities
Provides scientific input into clinical development plans, design of clinical trial protocols, design of case report forms, preparation of informed consent forms, medical and statistical supervision plans, review of SAE reports, Investigational Brochure updates, Annual Safety reports, and biomarker and pharmacogenomics plans.
Provides during conduct of trials data review on an ongoing basis, prepares summary analyses of study results and assists in preparing presentations at scientific meetings and publications.
Maintains close interactions with relevant related internal functions such as Toxicology, Pharmacology, Drug Safety, Regulatory, TA Oncology, Exploratory Medicine, Biomarker group and Medical Communication Experts.
Liaises with external experts as needed to keep abreast of latest clinical and scientific developments and to maintain up-to-date medical and scientific knowledge necessary to support the GEDU Oncology
Supports clinical trial related submission activities (e.g., IND, protocol submissions, amendments, response to questions from Health Authorities) and ensures medical/science/clinical trial related interactions with investigational sites.
Acts as scientific expert on the products in the GEDU Oncology and increases scientific knowledge by attending conference and appropriate international congresses.
Assists in organizing scientific development activities within the GEDU Oncology, such as journal clubs, internal educational courses and invitations to external speakers.
Contributes, if needed to the scientific/medical contributions to in-licensing opportunities under the leadership of the Head or Deputy Head of the GEDU Oncology, together with Medical Directors.
Contributes to evaluations of potential additions to the internal portfolio which could complement the range of targets and indications represented in the ongoing portfolio. |
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Doctorate
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5 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Geneva |
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Ph.D. with good translational knowledge or M.D. with strong scientific background .
Perfect command of English (oral and written).
At least 3 years experience in Clinical Development.
Solid overall experience in pharmaceutical development, with proven ability to adapt to changing environments and to respond to the requirements of multiple stakeholders.
Experience in management and strategic planning. Experience in authoring clinical study-related and submission documents.
Experience of interaction with health authorities (Europe, US) and knowledge of regulatory submission formats (CTA, IND, CTD, eCTD). Good knowledge of GCP and ICH guidelines/practices.
Ability to work in a matrix environment.
Excellent initiative and driven by the sense of the urgency.
Fast understanding of complex scientific/clinical issues.
Excellent communication skills both verbal and in writing.
Presentation skills.
Team player.
Entrepreneurial spirit and action/results driven.
High-energy level person, motivator.
Flexible.
Willing to travel when necessary (up to 20% of the time). |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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