Clinical Research Scientist (CRS)

Sorrento Therapeutics • New York, NY 10007

Posted 1 week ago

Job Description

ABOUT US

Sorrento Therapeutics Inc. is a fast growing, clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its' extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB library"), clinical stage immuno-cellular therapies ("CAR-T"), intracellular targeting antibodies ("iTAbs"), antibody-drug conjugates ("ADC"), and clinical stage oncolytic virus ("Sephrevir").

We attract smart people who play well with others. We're small enough for your ideas to make a big impact, and large enough to offer you opportunities to grow professionally at any stage of your career.

If you're a quick learner, enjoy working in the biotech industry, and share our mission of providing ground-breaking impact to medicine, each other, and our patients, Sorrento Therapeutics is the place for you!

WHAT WE ARE LOOKING FOR:

The Clinical Research Scientist (CRS) provides scientific insight and clinical research experience in support of clinical trials. This position requires a scientific or medical background as the CRS works closely with the physician leading the study. Previous experience working in a pharma or biotech company in a similar role as this job description is preferred. The CRS is expected to work collaboratively with other study team members including but not limited to Clinical Operations, Data Management, Biostatistics, Drug Safety, Drug Supply and Regulatory.

YOUR DAY-TO-DAY WORK INCLUDES:

* Prepare study protocols and informed consent documents. This includes authoring with some guidance, reviewing, and facilitating cross-functional review as appropriate.

* Contribute to CRF development, review of data management deliverables (crf design, edit checks, CRF completion guidelines, etc);

* Perform medical data review and author queries from a medical perspective. May monitor for safety and efficacy trends;

* Review and interpret study data (with guidance) as it relates to efficacy and safety;

* Review Statistical Analysis Plan; collaborate with statisticians for development of tables, listing and graphs;

* Assist the Medical Monitor (MM) in ensuring MM guidance is followed by sites/ study team; may draft responses to sites, IRBs and agencies;

* Along with the Study Team, provide relevant support to CROs in the management of clinical studies;

* Actively participate and contribute to study/project team meetings;

* Review scientific literature related to assigned clinical programs;

* Provide clinical and scientific expertise to other departments and line functions;

* Provide scientific input, review, and edits to clinical study reports (CSR) Investigator Brochures (IB), narratives, INDs, NDAs, briefing documents, annual reports, and other regulatory submissions. May assist in writing these documents;

* Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent.

* Assist with scientific preparations and presentations for, Investigator Meetings and Advisory/ Scientific boards. May prepare and present clinical data in these venues as needed.

* Prepare Data Monitoring Committee or similar committee charters. Prepare deliverables for meetings and present at meetings.

QUALIFICATIONS:

* Bachelors degree, Masters degree, PhD or Pharm D. required (in life sciences), and at least 3 years of biotech/pharma experience with at least 2 years in clinical research;

* Able to work independently, exercise sound judgment, and escalate issues when appropriate;

* Medical/scientific writing skills; Medical/scientific and clinical research knowledge;

* Analytical skills/ Ability to interpret data;

* Understanding of global clinical study design and drug development processes;

* Knowledge of GCP and ICH Guidelines;

* Good presentation skills;

* Detail-oriented, well-organized;

* Proficient in: Microsoft Word. Excel, PowerPoint.

YOUR REWARD

* The chance to grow your career in a dynamic, growing, and collaborative environment on the cutting edge of cancer immunotherapy development.

* Earn a competitive salary while allowing you to focus your attention on innovative science

* A comprehensive benefits package including: full medical (HMO, PPO, HSA, and FSA options), dental, vision, life and disability insurance, company-matching 401(k), 10 paid holidays, three weeks paid vacation, plus stock options.

If this sounds like the right career to fit your personality and interests, we're looking forward to meeting you.

Principals only. Recruiters, please don't contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

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