ABOUT US
Sorrento Therapeutics is a leading biotherapeutics pharmaceutical company with a mission to develop novel therapeutic approaches that extend and enhance cancer patients’ lives, either by reducing the malignancy of life-threatening tumors, improving the safety of current treatments, or by bringing novel solutions to make living with cancer more tolerable. Sorrento is based in San Diego, California, with world class antibody engineering capabilities and a robust early stage pipeline focused on immuno-oncology, infectious disease, and non-opioid pain.
Sofusa® is a Division of Sorrento Therapeutics (www.Sofusa.com) focused on delivering superior therapeutic solutions through lymphatic drug targeting. The Sofusa (“soft infusion”) technology is a disruptive new method of treatment that represents a potential breakthrough in drug development. The proprietary nano-structured microneedle and microfluidics system are designed to access the tiny systemic and lymphatic capillaries just below the epidermis. This unique design offers the potential to deliver therapeutically advantaged drugs by precisely tuning PK profiles and delivering higher concentration of drug into the lymphatics vs traditional injections. This is particularly exciting for the Sorrento pipeline focused on the development of biologic drugs targeting the immune system (e.g. anti-TNFα for autoimmune conditions, anti-PD1 in immune oncology, and T-VIVA vaccine for SARS-CoV-2). In preclinical models, Sofusa has demonstrated the ability to improve efficacy response and/or reduce side effects vs intravenous or subcutaneous administration. In addition, Sofusa’s facility in Sandy Springs, GA leverages unique capabilities in lymphatic imaging and pre-clinical research to support development of translational models in lymphatic drug delivery.
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 by December 8, 2021, 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:
Sofusa is seeking an experienced Manager, Clinical Operations. This position will be responsible for managing clinical activities to support human clinical studies for Sofusa®. The Sofusa lymphatic drug delivery system is very novel with the potential to dramatically change clinical outcomes. Proper translation into the clinic (at the direction of the Sofusa Chief Technology Officer) and execution of Sofusa clinical programs (at the direction of the VP of Clinical Operations) will be critical for successful clinical research and development.
WHAT YOU’LL DO:
Provide proactive program management and communications with clinical operations, regulatory, and the Sofusa CTO to ensure alignment and successful execution of clinical Provide oversight for Sofusa studies to ensure progress according to study standards, budgets, quality, and timelines. Prepare and/or supervise development of study related materials, manage vendor relationships, and proactively identify project risks and development of remediation measures. Manage clinical vendor selection and deliverables including those of Sofusa CROs, contractors/consultants, and suppliers Review/Contribute to the development of study documents including protocol, ICF, amendments, training videos, and any interim/final study reports, etc. Assist in clinical site selection in alignment with Clinical MD team and CRO. Build and execute processes, procedures and capabilities needed to effectively translate Sofusa drug delivery into successful human clinical trials. Provide clinical expertise and input into design requirements of devices for clinical and commercial use. Be an expert voice and advocate for clinicians and patients during the device design process and in Design Control meetings. In coordination with the CRO, lead recuring clinical operations program management meetings, including meeting minutes and follow ups. In coordination with the CRO and Sorrento Clinical Operations, ensure approporate processes in place for data management, safety monitoring, and reporting. At the direction of the CTO, develop and standardize device clinical processes and templates to enable CROs to efficiently and consistently evaluate and report on adverse events, complaints, and failures associated with the clinical trials (e.g. device application, imaging assessments, dermatologic assessments, VAS pain scales, etc) Manage communication processes with site and organize / maintain clinical documentation for easy access by Sofusa and Sorrento stakeholders. Ensure compliance with device quality assurance and regulatory guidelines during clinical studies and in the development of documentation.
EDUCATION AND QUALIFICATIONS:
BS or MS in life sciences or health related field (biological sciences, allied health professional). 5+ years experience in clinical operations, pharma product development, CRO service and/or clinical nursing. Experience managing clinical trials (working for a CRO, trial sponsor, primary investigator, or clinical trial site) Familiarity with clinical execution of complex device clinical studies required. Strong verbal and written communication skills with attention to detail in writing content (e.g. IFU’s, training manuals) and in review of other’s work. Experience in medical writing preferred. Strong program management with problem-solving and conflict resolution skills. Experience identifying, selecting and managing CROs and/or laboratory and pathology services preferred. Familiarity with diagnostics and imaging technologies preferred. Proven leadership skills in managing project teams through Phase I-III clinical trials preferred. Strong interpersonal skills, passionate, a collaborative team player who recognizes input from others is an opportunity to learn and to grow. Strong understanding of cross-functional processes and relationships in pharma product development including clinical operations, biostatistics, data management, subject randomization, device/product supply management, and regulatory affairs. Ability to function in a lean, fast paced and dynamic start up environment. Proven ability to work independently, meet deadlines and be results-oriented. Ability to travel 35% of working hours (peaks during clinical studies) Be passionate, be flexible, enjoy the experience. This is a unique opportunity and role with a fast growing biotech company with significant opportunity for learning and rapid growth in responsibility and compensation with successful performance.
YOUR REWARD:
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!
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Sorrento Therapeutics, Inc. is an Equal Opportunity Employer