Senior Director of Clinical Operations

ORIC Pharmaceuticals

San Diego, CA, US
  • Job Type: Full-Time
  • Function: Operations
  • Post Date: 05/03/2021
  • Website: oricpharma.com
  • Company Address: 240 E. Grand Ave 2nd Floor, South San Francisco, CA, 94080

About ORIC Pharmaceuticals

ORIC is a pharmaceutical company dedicated to discovering and developing therapies towards overcoming resistance in cancer. It offers a small molecule antagonist of the glucocorticoid receptor, which has been implicated in resistance to various treatment modalities, including chemotherapy, immunotherapy, and anti-hormonal therapy, and across multiple cancers.

Job Description

Plan, implement and manage clinical studies and clinical research projects from concept to completion.  Contribute to the completion of regulatory and registration submissions.  Participate in project teams as the project team leader or as an active member.  Manage clinical vendors and CROs, including budgets, contracts, and timelines.

Responsibilities:

  • Management of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements
  • Recruit global study sites and foster relationships with study investigators
  • Assist in RFPs, vendor selection, and negotiation of vendor contracts and budgets
  • Manage study vendors (e.g., CRO, IRT/IXRS, laboratories)
  • Monitor the progress of trials including enrollment and clinical trial material inventory (e.g., investigational product, ePRO devices, PK/PD/PG kits, pathology kits)
  • Provide progress updates to management
  • Assist in the production of clinical documents required for the conduct of clinical studies, such as clinical protocols, informed consent documents, investigator’s brochures, and safety management plans in compliance with federal regulations and good clinical/medical practices
  • Assist in ongoing data interpretation and medical writing of study reports, conference abstracts, posters and presentations, and manuscripts for publication
  • Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
  • Assist with presentation of clinical program at Site Initiation Visits and Investigator’s Meetings
  • Assist in study and departmental budgeting
  • Review and negotiate site contracts and budgets
  • Assist with monthly accruals and projections of site and vendor budgets
  • Assist in case report form (CRF) development and programming of electronic data capture
  • Assist in reviewing project review specifications for IRT/IXRS, ePRO, and other applicable services
  • Participate in data cleaning and database locking
  • Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports
  • Develop procedural plans
  • Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator’s feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues
  • Provide direct management, leadership and mentoring of other junior Clinical Operations team members
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Qualifications & Experience:

  • BA/BS with science major, or an equivalent combination of education and related experience
  • At least 8-10 years of relevant oncology experience in clinical operations in pharmaceutical/biotechnology company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3)
  • Must be able to thrive in an entrepreneurial, fast-paced, and dynamic work environment
  • Must be organized and be able to communicate effectively
  • Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities
  • Experience with managing study vendors (e.g., CRO, IRT/IXRS, laboratories)
  • Ability to work well with global, multi-disciplinary teams
  • Experience in practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations
  • Experience with electronic data capture and data management software
  • Experience in the management of CRAs
  • Excellent oral and written communication skills
  • Up to 25% travel

About ORIC Pharmaceuticals:
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer.  ORIC’s lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors.  ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. ORIC’s other product candidates include (1) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, and (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.