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Manager Operational Excellence - Global Development Operations

Company name
Pharmacyclics LLC

Sunnyvale, CA

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Job Description
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer. More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer. Summary: The Global Development Operations (GDO) Operational Excellence Manager is responsible for identifying, facilitating and managing continuous process simplification and optimization initiatives across Clinical Operations (both US and ex-US) in close collaboration and consultation with the business and under guidance of the Director and Sr Director of Operational Excellence. The role will report into the Director of Operational Excellence and will be particularly focused on ensuring our Clinical Operations training platform is fully compliant with global standards throughout the entire study process. The ideal candidate will be proficient in taking initiative, have a hands-on approach and must demonstrate strong cross-functional facilitation skills to continuously drive improvement and ensure the Ways We Work values are integrated throughout GDO's culture. Responsibilities: •Collaborates with Pharmacyclics GDO to identify and address CTA, CRA, and CTM training needs. •Assists with the development of specific curricula as related to the CTA, CRA and CTM roles. •Works to implement ongoing training as related to the CTA, CRA and CTM roles. •Assists with education, training, and mentoring of GDO clinical operations personnel. •May facilitate co-monitoring site visits (PSV, SIV, IMV, COV, Oversight Visits, Quality Oversight Monitoring Visits) with CO team members and accompany team members for training purposes. •Creates objectives, goals, and evaluations to be used to measure performance outcomes for all site visits conducted for training purposes. •Assists with providing oversight of CROs, independent CRAs and vendors, including managing cross-functional teams. Provides guidance on site issues and ensures issues are escalated to the specific study team CTM in accordance with the project escalation pathway. •Collaborates and assists with any other process simplification and optimization initiatives taken by the Operational Excellence team as needed. Requirements: •Mentoring of junior GDO staff to include, but not limited to, IMV Report Review, Protocol compliance, IP Accountability, bio-sample reconciliation, and issue(s) escalation. •Coach members of the CTA and CRA job families. •Act as a change agent who is dedicated to inspiring positive change. •Motivate and influence others to gain support for ideas and strategies. •Establishes productive relationships and partnerships across the organization to ensure alignments of goals and deliverables. •Make sound decisions that are consistent with the Ways We Work. •Seeks opportunities to develop oneself and others to continue to achieve sustained growth. •Maintains completion of required corporate training on standards, policies, work instructions by due date. •Performs other work-related duties as assigned. Qualifications: •Minimum of 10 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 5 years on-site monitoring experience) •Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision •Proven ability to effectively teach complex information across participants with experience and capabilities •Good organization and project management skills •Good interpersonal and communication skills (both written and oral) •Expert knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines •Strong leadership skills, self-motivated, adaptable to a dynamic environment •Able to collaborate effectively with internal project teams and Pharmacyclics business partners •Proficiency in MS Word, Excel, PowerPoint and SharePoint. •Ability to establish priorities, excellent sense of urgency and ability to collaborate (interpersonal, relationship management) with study teams, cross functional team members and external partners/vendors •BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but is not required •On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 20 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Company info

Pharmacyclics LLC
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Company Profile
Pharmacyclics Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are synthetic small-molecules designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three candidates in clinical development and several molecules in preclinical development.

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