Sorrento Therapeutics – Senior Manager, Clinical Operations (BB-A0D29)

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 is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD, COVI-SHIELD, COVI-AMG, COVI-DROPS, SALICYN – 30 and MESENCHYMAL STEM CELL; and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRACE.
We attract smart people who play well with others. We are 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 are 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:
Sorrento Therapeutics (“Sorrento”) is seeking experienced Senior Managers, Clinical Operations who has direct experience running field based clinical diagnostic studies and who will be responsible for all aspects of assigned Sorrento’s clinical trial portfolios compliance with GCP’s, SOPs and ICH standards within established timelines, standards, and budgets.
WHAT YOU’LL DO:

• Manage assigned clinical protocols to ensure progress according to study standards, budgets, quality, and timelines.
• Prepare study related materials, manage vendor relationships, and proactively identify project risks and development of remediation measures.
• Manage vendor selection and deliverables including those of assigned CROs, contractors/consultants, and suppliers such as Central Lab, IRT, data management, ePRO, e-CRF, eTMF, Investigational Product, and Bioanalytical test kits.
• Ensure study progress is aligned with goals and projections. Ability to troubleshoot and correct, and alert others (communication, and/or escalation) as needed.
• Ensure proper trial documentation completed in timely and accurate manner.
• Prepare, coordinate, review and /or oversee key trial documents such as Monitoring, Project and Risk Plans, Study Communication Plan, Data Management Plan, CRFs, Pharmacy, Diagnostic and Training Manuals.
• Review/Contribute to study team-developed documents including protocol, ICF, amendments, DSMB and any interim/final study reports, etc.
• Prepare/Review key departmental SOPs and working practices.
• Ensure proper sites are selected in alignment with Clinical MD team and CRO.
• Maintain and provide relevant and accurate information for monthly study reports (including enrollment metrics, timelines, analysis of the study status and identification of potential risks) Investigational Product (IP) and Bioanalytical supplies.
• Manage budget, change orders, contracts, and financial updates.

EDUCATION AND QUALIFICATIONS:

• Bachelor’s degree plus at least 7 years of experience in pharmaceutical industry or Advanced degree plus at least 5 years clinical research experience.
• Strong interpersonal and communication skills (verbal and written)
• Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills.
• Ability to work in an international environment with internal and/or external partners (CROs, Clinical Sites, etc.).
• Ability to adapt and be flexible to change and managing internal and external impediments.
• Working awareness of ICH GCP and relevant local laws, regulations, and guidance.
• Excellent Leadership and Project Management skills.
• Excellent communication and relationship building skills.
• Knowledge of and commitment to data management excellence, compliance with all aspects of clinical trials.
• Experience and therapeutic expertise in diagnostic testing, 510 (k) products, devices and infectious disease clinical studies strongly preferred.
• Early phase 1 and 2 experience preferred.
• Knowledge of key clinical trial systems such as eCRF, ePRO, eTMF a plus.
• Computer, technical skills (Word, Excel, spreadsheets, PowerPoint, and related tracking tools) required.
• Ability to communicate fluently in Spanish is a plus.

YOUR REWARD:

• Support scientists who are on the leading edge of immunotherapies and diagnostics for the detection, treatment, and prevention of COVID-19 and other infectious diseases.
• 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 purchase plan.

If this sounds like the right career to fit your personality and interests, please apply, we are looking forward to meeting you!
Principals only. Recruiters, please do not contact this job poster.
Sorrento Therapeutics, Inc. is an Equal Opportunity Employer
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