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VP of Clinical Operations

Arcus Biosciences, Inc.

This is a Contract position in Hayward, CA posted July 30, 2020.

Overall Description Arcus Biosciences (NASDAQ: RCUS) is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs.

AB928, the first and only dual A2a/A2b adenosine receptor antagonist in the clinic, is being evaluated in several Phase 1b/2 studies across multiple indications, including prostate, colorectal, non-small cell lung, pancreatic, triple negative breast and renal cell cancers.

AB680, the first small-molecule CD73 inhibitor in the clinic, is in Phase 1 development for first-line treatment of metastatic pancreatic cancer.

AB154, an anti-TIGIT monoclonal antibody, is in randomized Phase 2 development for first-line treatment of metastatic non-small cell lung cancer in combination with zimberelimab and AB928.

Zimberelimab (AB122), Arcus’ anti-PD-1 monoclonal antibody, is being evaluated in a Phase 1b study as monotherapy for cancers with no approved anti-PD-1 treatment options, as well as in combinations across the portfolio.

Arcus currently sponsors 9 on-going clinical trials and plans for future growth.

For more information about Arcus Biosciences, please visit www.arcusbio.com.

This leadership position is accountable for resourcing, development, training and management of a highly performing clinical operations team.

The position will provide strategic direction for, and executive oversight of, operational matters impacting Arcus’ clinical development programs, including trial planning, study / protocol design and development, execution within budget and timelines, quality and compliance.

Key Responsibilities: Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators Ensure high standards for compliance with company SOPs, ICH-GCP guidelines, governing regulations and patient safety standards Lead and mentor the multiple functions and multiple levels within the clinical operations group to ensure successful internal trainings are conducted, and project, organization and individual goals are met Serve as an advocate for professional development of Clinical Operations staff Provide continuous assessment and alignment of the clinical operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution; Accountable for establishing and maintaining inspection readiness across multiple programs Develop, negotiate, and manage the clinical operations budget Represent Arcus in external facing meetings with KOLs, vendors, patient advocacy groups and the like Collaborate with other functions including legal and finance to establish new initiatives and to ensure continuous and smooth operations of on-going activities Oversee and troubleshoot clinical development program challenges, processes, activities and risk mitigation strategies pertaining to the conduct of clinical trials and key milestone deliverables, with direct reports/functional leads Oversee and provide relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget Contribute to business development activities providing clinical expertise and strategic operational considerations Clinical representative of executive teams including development senior leadership team and applicable CRO/vendor governance and due diligence teams Clinical core team member for program-level management decisions Lead by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goals Communicate regularly and effectively with senior leaders across the R&D organization Qualifications Bachelors, Masters or Doctorate degree in a life-sciences discipline plus 10 years progressive experience in clinical drug/device development, including 7 years of Clinical Operations line management experience Domestic and international clinical trial execution experience required Post-approval clinical management experience a plus Direct management experience over clinically related functions Experience working in a matrix environment with other functional groups (e.g.

Regulatory, Medical Writing, Med Affairs, Commercial) where consensus across multiple opinions and good working relationships are important In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Experience in complex, rare and/or pediatric diseases, preferred Ability to manage early phase clinical programs up through to regulatory filing Demonstrated track record of successfully developing and executing on clinical development plans Proven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activities Proficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve functional area and/or organization goals Analytical thinker with excellent problem-solving skills Excellent verbal and written communication skills Excellent planning, organization, and project management skills Flexibility to travel domestically and internationally, as required Proficiency with project software including Excel and Microsoft Project Experience with electronic record-keeping, e.g.

Veeva Vault and eTMF, a plus