Associate Director, Development Operations Data Currency

Location
San Francisco, CA, United States
Posted
Dec 04, 2018
Ref
3332-530-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Manages activities across all company development programs driving towards a state of consistent data currency supporting company objectives around analyses and publication plans.

This includes contributing to the strategic and operational leadership relative to the direction, planning, and execution of clinical programs with regards to the data collection activities (including but not limited to clinical data and specialty lab data - e.g.: central imaging; central ECG). Works with senior Clinical Operations project teams and applicable vendors to develop, establish and approve process focused on data currency for all clinical protocols and provides data currency updates. Monitors vendor performance and adherence to expectations and metrics. Proactively engages with other Nektar functions or outside groups to ensure data currency is maintained on clinical programs May select, develop, and evaluate personnel to ensure the efficient operation of the function. May also represent Development Operations focused on data currency for partnered programs. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Develops and gains approval for functional processes, goals, and coordinates their implementation. Occasionally works on abstract problems across functional areas of the business. Regularly interacts internally and externally with vendors and team members, requiring negotiation of extremely critical/urgent matters.

Department management responsibilities include, but are not limited to: • Ensure the achievement of project and department objectives; collaborate with management peers across the department and company • Develop and implement optimization strategies to increase compliance, improve study team training methods to promote achievement of data currency goals and provide ongoing clinical program support • Manage resource and workload utilization of direct report and contract staff • Directs internal staffing and performance management, including hiring, training, coaching and performance reviews • Develop, monitor, and report on key performance indicators across programs • Contributes to the development of study-specific documents (e.g.: specialty lab charters; monitoring plans; data plans; other study plans). • Partners with other functions to develop and drive cross-functional data reviews tailored to the study phase (start-up; maintenance; close-out) and endpoints. Works with the CRO, GCP/QA, and internal field oversight to identify and address trends. • Harmonizes cross-functional data review and data currency activities across programs where appropriate. • Contributes to the development of a risk-based framework for select studies using data from multiple data sources (e.g.: EDC, CTMS, Protocol Deviations, Central Labs, Specialty vendors) and partners with study teams and/or field oversight organization to provide risk-based sponsor oversight of key sites.

Management responsibilities include: • Identifies functional resource gaps; devises and implements solutions • In collaboration with cross-functional management peers, develop a consistent support strategy for development projects • Drives risk analysis and develops solutions • Establish a visible Company profile representing Development Operations data currency efforts • Manage and coordinate external service providers and vendors, serving as primary point of contact, ensure thorough communication of data currency expectations, ensuring agreed deliverables are achieved on time, and monitoring key performance indicators • Ensure training and supervision for functional staff • Ensure operational excellence and integrity through adherence with policies and procedures, GCP, ICH, FDA, EMA and all relevant international regulatory requirements • Provides functional updates to Development Operations Management

A Bachelors minimally or higher degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 10+ years pharmaceutical clinical operations experience in early and/or late stage studies, at least 8 years of personnel management experience, and 4 years managing vendors is required. Additional clinical data management experience and experience managing specialty lab vendors is strongly preferred. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.