Associate Director, Clinical Operations

Sunnyvale, CA
Feb 15, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
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.

General Position Summary/Purpose:

The Associate Director/Director leads Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs) and/or Clinical Trial Assistants (CTAs) with regard to the planning, resourcing, implementation and management of clinical trials according to timelines, budget and applicable regulations. This position will be responsible for managing the overall operations of a clinical research program, which may involve multiple simultaneous clinical studies of all phases of clinical development (phases 1-4).

Key Accountabilities/Core Job Responsibilities:

Study Planning and Conduct:

    Ensures that proper activities are properly aligned with corporate objectives Collaborates interdepartmental and scientific activities specific to implementation and conduct of clinical programs Accountable for quality data and meeting timelines and providing guidance to study team as needed. Oversees the review of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures Oversees the review and the approval of the vendors, vendor on-boarding and management throughout the life-cycle of the study Provides oversight for timely follow up to CQM/CQA, site and vendor audits as required Responsible for hiring, training, mentoring and managing study team Develops effective and collaborative working relationships environment amongst internal/external team members and vendors Serves as point of contact for issues escalation and resolutions on assigned projects Participates in interim and final report preparation for regulatory submissions Ensures that sponsor monitoring quality oversight visits to sites are conducted by qualified team members for adherence to protocol and GCP, as required

Project Management:

    Provides project management leadership for contracted vendors Reviews reports timelines for milestone deliverables generated by CTMs Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders Approves metrics and updates for reporting to management, as required

Financial Planning and Management:

    Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocation Oversees the development/management vendor scope of work (SOW) per contract, quality, budget, and detailed timelines Reviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sites


    Actively contributes in Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs, WIs and department level training and cross project initiatives. Presents at departmental, interdepartmental and investigator meetings Actively participates in the departmental goal setting and ensures individual goals align with the overall departmental and corporate goals Conducts ongoing performance management, performance reviews/appraisals and career development planning for all direct reports Responsible for taking required training, updating and maintaining own training records and setting the example for others to maintain their training records Performs other work-related duties as assigned


    In-depth knowledge of clinical research operation, including interpretation and implementation of ICH/GCP guidelines and Food and Drug Administration (FDA)/European Medicines Agency (EMA)/Other Health Authority (HA) regulations, is required Demonstrates advance knowledge of design and phases of clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices Excellent attention to detail and accuracy in work, ability to multiple tasks, strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality Understands line management function Understands, identifies, mitigates, and communicates risks at the study or program level Proven experience working in a global, matrix organization on a global/international clinical development program Excellent sense of urgency to deliver at/surpass study conduct targets Strong leadership skills, self-motivated, adaptable to a dynamic environment, interpersonal, organizational and supervisory skills Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools Proficient in Sharepoint with filing systems is highly desirable

Education and Experience Requirement:

    BA/BS or equivalent degree in scientific discipline. Advance degree preferred. 10+ years of clinical trials research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting for Associate Director; 13+ years for Director Minimum 5 years experience in a management/supervisory role Previous experience with development of SOPs, Work Instructions, and procedures Demonstrated financial acumen in planning and managing clinical program budgets Proven ability to successfully plan, implement, and manage multiple clinical programs/studies Experience at/or oversight of outside clinical research vendors (CROs, central laboratories, imaging vendors, IXRS, etc.) Extensive experience and accomplishments in the pharmaceutical or related industry, e.g., with proven Global Phase 1, 2, 3 and 4 study experience and with filing INDs and NDAs is required Regulatory inspection support experience preferred Experience in various therapeutic areas; Oncology is preferred