Reporting to the Vice President of Clinical Development and Translational Medicine at ChemoCentryx the Clinical Department at ChemoCentryx is seeking an Associate Director/Senior Clinical Scientist (PhD, PharmD or MD degree required, title dependent on the level of experience) to support the Clinical Development activities for a number of robust and innovative drug development programs (Phase 1-3). Experience with clinical trials in an established industry organization is a must, and experience or training in immunology or cancer-related research is highly preferred. The candidate will be able to work in a highly scientific and vibrant clinical research environment, join at a time of substantial growth of the organization, and have the opportunity to get exposure to a wide spectrum of clinical pharmaceutical development activities.
The Associate Director/Senior Clinical Scientist will work independently with appropriate supervision of the VP of Clinical Development and Translational Medicine, in responsibilities associated with all aspects of design, setup, and analysis of Phase 1 – 3 clinical trials, write up of scientific or regulatory documents or publications, and the support of monitoring activities where appropriate. The candidate will have excellent analytical and communication skills, and the ability to interact effectively with internal stakeholders including Clinical Operations, Regulatory and Clinical Pharmacology, as well as with study investigators and their staff, CROs and vendors operating on behalf of ChemoCentryx. The individual may also be involved in other activities in the department including clinical plan development, potential partnering discussions, regulatory meetings, departmental meetings, planning and preparation for scientific meetings, staff training, and patient recruitment initiatives. The candidate is expected to work independently and efficiently in a dynamic, fast-pace work environment of a rapidly growing organization and deliver the highest standard of quality work.
- Work closely with the VP of Clinical Development and Translational Medicine and the Clinical Science team, to interface internally and externally as the primary clinical science lead of assigned studies and programs.
- Design, author and review clinical protocols, protocol amendments, informed consent documents, CRFs, monitoring plans, data analysis plans, interpretation of results, clinical study reports, and supporting work for sections of regulatory submissions, such as, INDs, CTAs, NDAs, MAAs and regulatory agency briefing packages, etc.
- Will be actively involved in planning, preparation and participation of regulatory meetings, e.g., End-of-Phase 2 meeting or other regulatory adhoc meetings.
- Prepare, present, and defend complex aspects of protocol design and/or study data at investigator and internal meetings.
- Responsible lead for the scientific execution and monitoring of the clinical trials under appropriate supervision hereby partnering closely with representatives of Clinical Operations, Regulatory Affairs, Clinical Pharmacology, etc.
- Closely collaborates with clinical trial investigators and key opinion leaders during all phases of the clinical trial and program.
- Prepare and review draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators.
- Assist in researching, drafting and authoring of sections or entire documents, as assigned, such as clinical study reports and documents, investigator brochures, etc.
- Critically analyze and synthesize complex information from reviews of the scientific/clinical literature.
- Excels working in cross-functional teams as the science lead together with representatives of Clinical Operations, Regulatory, Biometrics, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
- Includes travel up to 30% at times..
Required Skills and Experience:
- Requires a PhD, PharmD or MD degree required with a minimum of 5 years of pharmaceutical/biotech industry experience.
- Experience in one or more of the following area(s) is desirable: Immunology, oncology, nephrology, and rheumatology.
- Has routinely developed, authored and reviewed Clinical Study protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, and other regulatory documents.
- Has successfully conducted clinical trials in a GCP/ICH compliant environment in a cross-functional team environment including representatives of Biometrics, Clinical Operations, Regulatory, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
- Has applied important concepts associated with the clinical development process, e.g., clinical trial design, randomization, masking, data collection, quality control, basic statistical methodology supporting study design, data interpretation and presentation and publication.
- Has demonstrated the ability to analyze, interpret, and present complex scientific clinical data to both subject matter (e.g. key opinion leaders) and non-subject matter experts and is able to draw scientifically robust and defendable conclusions.
- Has advanced the development strategy of clinical programs and pivotal clinical trials.
- Has demonstrated solid understanding of biostatistics, trial planning and sample size generation in collaboration with the biometrics group.
- Has basic understanding of clinical pharmacology.
- Has worked directly with Clinical investigators and is able to lead protocol-related discussions (e.g. entry criteria of the protocol) with representatives of clinical operations, investigators and investigators trial staff.
- Has demonstrated scientific expertise in the presentation and publication process with a track record of publishing peer-reviewed scientific data, e.g., posters, oral presentations, review articles, and manuscripts.
- Prior training and work in an environment applying Good Clinical Practices (GCPs) is necessary.
- Has outstanding ability to present and communicate scientific clinical data in a clear and concise manner.
- Has excellent business presence and demonstrated the ability to build/maintain relationships with internal and external stakeholders.
- Track record of creativity, high performance, and demonstrated ability to work independently and meet deadlines in a dynamic, fast-pace work environment and deliver the highest standard of quality work.
- Excellent verbal and written skills along with the ability to work collaboratively in a dynamic and creative environment is essential.
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