- Support the preparation of clinical development plans, trial protocols, case report forms, and study operational plans that are scientifically rigorous, clinically relevant, operationally feasible, while adhering to GCP and regulatory requirements
- Establish and maintain credible relationships with clinical investigators and medical/scientific experts
- Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
- Assist Data Management with the review of clinical data and resolution of queries
- Perform medical monitoring activities and reporting in partnership with Study Responsible Physicians/Scientists, including evaluating clinical trial adverse events and reviewing clinical laboratory results
- Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials
- Draft and coordinate completion of clinical study reports
- Prepare responses to questions from Ethics Committees and Health Authorities
- Support integrated document development for marketing authorization filing
- Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
- Support preparation for FDA Advisory Committee and EU Oral Explanation
- Present relevant clinical data to internal and external stakeholders
- Review medical literature and related new technologies relevant to the assigned projects.
- Other responsibilities may include utilizing nonclinical PK and PK/PD data (including use of modeling and simulation techniques) to project optimal clinical dosing regimens, doses based on pharmacological/clinical targets, human starting doses, and biomarker exploratory data (including biochemical and molecular data from quantification of mRNA, multi-panel flow cytometry, and protein expression)
- Collaborate with early research teams in assessing PK and other data for use in future programs and to optimize experimental design
- Author regulatory documents as it relates to clinical pharmacology data and design
- Evaluate and implement necessary tools and systems to organize and analyze data
- Conduct clinical studies with utmost integrity, professionalism, and organization
- PhD/PharmD with 5+ years of industry clinical research experience, preferably in immunology or a related therapeutic area. BS/MS/RN will be considered with additional industry and drug development experience
- Experience in late-stage drug development, with a preference for experience in immuno- inflammatory indications
- Strong analytical skills coupled with communication skills to present findings and relevant data
- Ability to survey and interpret scientific literature related to assigned projects
- Strong organizational skills and ability to thrive in a fast-paced startup environment while prioritizing and responding to changing business needs
- Demonstrated ability to collaborate effectively with cross functional teams and champion and drive solutions for clinical challenges
- Excellent written and verbal English communication skills
- Ability to interface with health authorities and represent clinical programs with integrity, polish, and professionalism
- Ability to travel domestically and internationally, approximately 10-20% of the time.
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Director, Clinical Scientist - South San Francisco, United States - Human Immunology Biosciences
Description
JOB TITLE:
Director, Clinical Science
DEPARTMENT:
Clinical Development
LOCATION:
South San Francisco, California
TYPE:
Full-Time (Onsite / Hybrid)
Are you an experienced scientist with clinical research experience in kidney and/or immune-mediated diseases? Join HI-Bio, Inc.
a clinical-stage biotechnology company based in South San Francisco, California, and be part of a fast-paced organization on an outstanding team of cross functional clinical research professionals translating scientific insights into our clinical development programs across a wide range of unmet needs.
Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact.
We have a precision medicine approach akin to oncology and grounded in human genetics. Our pipeline is strong and built through in-licensing and discovery. HI-Bio's team is made up of industry experts from science and clinical development. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.
We are seeking a senior Clinical Scientist to support clinical research activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases.
This position provides leadership in program development, execution, innovation, and optimization of clinical trials by including the latest insights on disease mechanisms, diagnostic approaches, and alternative therapies.
The Director will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications.
Additional responsibilities involve assisting with regulatory documentation by collaborating with discovery, development, and commercial colleagues, as well as managing external collaborations and gaining comprehensive knowledge of the literature related to the product(s) in development.
The responsibilities of this role may vary depending on the specific indication and trial requirements.The Clinical Scientist collaborates closely with Study Physicians/Scientists as a key member of development and core team. The role actively contributes scientific expertise to cross-functional clinical teams involved in the development of novel therapies.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.
Our ideal candidate will have significant experience in clinical trials for antibodies and can strongly communicate and present relevant clinical data to leadership and core teams.
KEY RESPONSIBILITIES:
QUALIFICATIONS:
HIBIO RECRUITING:
HI-Bio, Inc. is an equal opportunity employer.
We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
We are committed to creating an inclusive environment for all employees. HI-Bio Inc. does not accept unsolicited resumes from any agency that we have not directly engaged on a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to HI-Bio, Inc. from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and HI-Bio, Inc. and do not obligate HI-Bio, Inc. to pay fees should we hire from those resumes.
