Associate Director, Centralized SDTM- Inflammation
United States – Remote
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
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The Associate Director of Centralized SDTM (cSDTM) is responsible for providing direction and oversight for the development of study level SDTM databases for the Inflammation Therapeutic Area (TA). They will accomplish this through collaborations with Biometrics TA SP Leads, Biostatistics, Clinical Programming (CP), and CDM. They will collaborate and work closely with their Vendor(s) for the production and validation of the SDTM deliverables during the SDTM development phase of the study life cycle. During the development phase the AD cSDTM will monitor status, confirm conformance to applicable standards and regulations, review and approve mapping specifications, and provide vendor oversight utilizing Gilead tools, processes, and documentation.
In collaboration with the cSDTM team, strategic service providers, Cross-TA SP, Biometrics TA SP, CDS management, and Global Clinical Data Standards (GCDS), this role supports the development, deployment, maintenance, and process of centralized SDTM development. This role supervises and is accountable for the development of end-to-end SDTM development process and RACI, drives adherence to standards processes, oversight of strategic partners, and the timeliness and quality of deliverables.
The Associate Director of cSDTM, will work closely with CP and GCDS to support department goals of SDTM automation and TA agnostic mapping that meets all Gilead, CDISC, and regulatory requirementsResponsibilities
Communicates and Collaborates with Biometrics TA SP and Biostatistics, CDM, GCDS, vendor programming team, and cSDTM Head in performance of these responsibilities:
- Oversight for day-to-day operation of Inflammation TA area
- Provides support and resource allocations for day-to-day cSDTM delivery
- Works with Senior leadership on resource LE cycle and quarter forecasts
- Vendor Management responsibilities
- Ensures all deliverables are inspection ready and as such performs quality checks as defined by quality facing documents (e.g. quality oversight plans and/or procedural documents).
- Serves as lead communication pathway between Gilead and Vendor Lead
- Vendor Relationship Partner
- Risk Management and work with Vendor Lead for mitigation
- SME for SDTM
- Ad-Hoc Member for SMT, DWG, and Analysis Team meetings
- Vendor and cSDTM Resourcing planning
- Provide input into SDTM process strategies, technology improvements, and lead/Support process initiative workstreams for their function.
- Acts as lead on regulatory submission, regulatory/compliance audits for their function
- Liaison with Cross-Functional Business Partners and GCDS
- Represent Gilead SDTM management for FMT meetings
- Execution of Vendor Oversight activities to ensure timeliness and quality
- Provided SME support as needed
- Provides project/Process level oversight
- Assessment of Risks and work with TA Lead for mitigation
- Ensures assigned work complies with established practices, policies and processes, standards, and any regulatory or other requirement
- Management of issue logs and study documents including communication with Vendor Lead and resolution strategies
- Identify Vendor issues and communicate to Vendor TA Lead. Collaborate with Vendor TA Lead on resolution/mitigation of Vendor issues
- Responsible for timeliness and quality SDTM data in preparation for study analysis
- Continual review of process to identify areas for automation and areas for efficiency
- Collaborates with Vendor programming teams during the development of SDTM datasets and mapping specifications to define priorities and provide expertise (SME) in SDTM process at Gilead.
- Support GCDS in the development of TA agnostic data mapping specifications to provide efficiencies in the mapping process
- Support CP for the automation of SDTM mapping in eClinical elluminate module to support standard and direct mapping of data in the Gilead mapping template
- Utilize quality control processes, metrics, and other measures to ensure compliance with SDTM data standards.
- Provides leadership through proper guidance and direction to technical individuals, including external vendors or third-party organizations to develop and implement strategies and/or tools.
Experience in the management, oversight, development, validation, compliance, and submission of SDTM datasets in Inflammation is highly desired
Solid understanding of regulatory guidance and industry guidance such as CDISC as applied to Inflammation SDTM deliverables is highly desired.
- 9 years of experience and a BS degree in in Biostatistics/Computer Science or equivalent health-related, life science area or technology-related fields.
- 5 years of experience and a MS degree in in Biostatistics/Computer Science or equivalent health-related, life science area or technology-related fields.
- 3 years of experience and a PhD degree in in Biostatistics/Computer Science or equivalent health-related, life science area or technology-related fields.
- At least 9 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.
- Experience in pharmaceutical industry SDTM data set development, implementation, and submission required.
- Demonstrated experience in all phases of drug development and clinical research in multiple therapeutic areas. Demonstrated knowledge of industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
- Knowledge of SDTM best practices and tools and has a track record in applying own knowledge to significantly improve efficiencies.
- Ability to work in a fast-paced environment and be influential in reaching prompt decisions to support accelerated clinical trial development.
- Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project timelines and metrics.
- Demonstrated ability to establish effective business relationships with external stakeholders.
- Strong problem-solving, verbal, and written communication skills; independent and effective working in a multi-disciplinary environment.
- Experience and knowledge in all phases of clinical trials.
- Display aptitude for creativity and innovation.
- Project management, organizational and self-management skills with a focus on results for timeline and accurate completion of competing deliverables.
- Self-motivated to identify and resolve problems with a keen eye on details.
- Proven ability to collaborate in a global environment with colleagues and functional partners across time zones.
- Demonstrated negotiation skills to reconcile differing viewpoints and opinions into actionable decisions.
The salary range for this position is: $168,980.00 - $218,680.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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