Sr. Project Specialist

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!

Sorrento Therapeutics, Inc. is a federal government contractor and, in compliance with its obligations under current federal regulations, Sorrento requires all employees, including newly hired employees, to present proof of vaccination against COVID-19, unless the employee is legally entitled to an accommodation.  For further information, please refer to the Safer Federal Workforce Task Force’s September 24, 2021 Guidance for Federal Contractors and Subcontractors, available at: https://www.saferfederalworkforce.gov/contractors/.

WHAT WE ARE LOOKING FOR:

Sorrento Therapeutics (“Sorrento”) is seeking an experienced Sr. Project Specialist to join our team.

WHAT YOU’LL DO:

The Sr Project Specialist is responsible for supporting aspects of assigned Sorrento’s clinical trial portfolios compliance with GCP’s, SOPs and ICH standards within established timelines, standards, and budgets.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Work with Sorrento’s internal teams and external vendors/partners to manage aspects of assigned studies
• Work with internal teams/CRO to ensure that study timelines and objectives; escalate risk to timelines and budget are up to date per the study status
• Support internal team with revised scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.

• Support study set-up, maintain and close out study files and study information [e.g. KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries] on a variety of databases and systems.

• Support the review of study protocols, changes in eCRF design, laboratory manuals, pharmacy manuals, ICF’s, and other study-related documents.
• Support project level financial management, including review and approval of CRO and vendor invoices.
• Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
• Support the review of central clinical files and trial master file.
• Support team meetings as needed.
• Work closely with assigned Program/Molecule lead in alignment with company goals to meet timelines for FPI, LPI, CSR and other critical clinical milestones.
• Participate in the development, review and implementation of departmental SOPs and processes.

EDUCATION AND QUALIFICATIONS:

• Bachelor’s degree plus at least 3-5 years of experience in pharmaceutical industry.
• Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills
• Ability to adapt and be flexible to change and managing internal and external impediments
• Knowledge of ICH GCP and relevant local laws, regulations, and guidance.
• Self-motivated and work independently.
• Strong communication  (verbal and written) and team collaboration skills.
• Therapeutic experience in one or several areas such as immuno-oncology, pain, infectious diseases, monoclonal antibodies preferred. Early phase 1 and 2 experience preferred.
• Knowledge of key clinical trial systems such as eCRF, ePRO, TMF, Clinical and safety databases a plus.
• Computer, technical skills (Word, Excel, spreadsheets, PowerPoint, and related tracking tools) preferred.

YOUR REWARD:

• Support scientists who are on the leading edge of immunotherapies for the treatment of cancer. 
• Earn a competitive salary that allows you to focus your attention on your passion.
• A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, company paid holidays, and Flexible PTO, plus stock options.

If this sounds like the right career to fit your personality and interests, please apply, 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