Senior Director, Epidemiology Operations

Job Description

Responsible for the leadership and oversight of the clinical operations teams across the portfolio of Epidemiology studies supporting the end to end (study start up through publication/study close out) coordination and execution of observational or non-interventional research studies (including Post Authorization studies) in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Leads and directs team members in key study planning, development, and execution elements closely monitoring performance against objectives, quality and timelines throughout the study life-cycle. This individual will lead development and tracking of organizational KPI’s (Key Performance Indicators), provide high level performance and operational data for NIS work for the department. Collaborate with the Biostatistics and Research Decision Sciences.

Epidemiology Leadership Team in strategic planning, scientific and operational alignment, and prioritization for and delivery of portfolio goals and objectives. Responsible for facilitating and collaborating with key internal/external stakeholders in support of Epidemiology portfolio objectives. Provides oversight and guidance in managing partners and/or vendors. Builds talent and capabilities of team members through proactive coaching, mentoring and development opportunities. Establishes strategy and provides leadership and direction of initiatives which increase organizational capabilities and or support operational efficiencies. Includes management of direct reports including assignment of resources, professional development, and performance management.

Primary responsibilities for the role include:

• Demonstrated leadership in managing teams of people, research development programs and processes, leading meetings and influencing peers and direct/indirect reports in a matrixed environment. Ability to build, mentor and develop talent throughout the organization.
• Manages and provides feedback and developmental opportunities for direct reports.
• Advanced analytical skills to drive operational planning and execution.
• Strong strategic thinking capabilities, leads creation of organizational vision and empowers teams for success.
• Leads process/business improvement initiatives in collaboration with key stakeholders. Proactively identifies any gaps in current processes and or identifies areas for improvement.
• Manages a team of operational therapeutic area leaders and study managers (R2-R5) for non-interventional research, including leading/coordinating the recruitment, interviewing, hiring, training and on-boarding & coaching of new personnel.
• Leads the development of standard reporting deliverables for assigned TA(s) which support the development of performance metrics and KPI’s and assist to drive strategy for the execution of non-interventional studies (NIS), as well as resource planning/allocation.
• Provides updates and metrics for portfolio of Epidemiology studies for sharing with Biostatistics and Research Decision Sciences Epidemiology leadership, including highlighting any risks, delays and mitigation plans.
• Leader of the Global Clinical Trial Operations Epidemiology Operations Leadership Team, raise for awareness/discussion issues which need attention, contributes to development of solutions of business challenges and which contributes to the overall evolution of the organization.

Education:

• Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred. Master’s degree (preferred) in Public Health (or closely related scientific discipline such as epidemiology, health administration, biostatistics or biological sciences).
• Project Management certification / training (PMP) and / or coursework & training in Project Management strongly preferred.

Experience & Skills

• 12+ years of work experience within clinical/observational research or equivalent or MPH/MS with 10+ years’; or PhD with 8+ years’ relevant career experience.
• Significant project management experience, with demonstrated track record of accomplishments.
• Extensive experience with the planning and execution of strategies for drug / vaccine product development with demonstrated ability to translate knowledge and expertise to other development teams and functional areas.
• Minimum 3 years direct people management experience.
• Ability to effectively delegate and assign work activities to meet business needs.
• Advanced knowledge of non-interventional / regulatory requirements (e.g. GPP), company policies and SOP’s. Experience working within research compliance requirements ( Good Pharmacoepidemiology Practices , Good Clinical Practice ).
• Strong business acumen, understanding of company structure, business priorities.
• Excellent communication and interpersonal skills, able to collaborate with and influence a wide variety of stakeholders across organizational levels.
• Well-developed and effective team facilitation and leadership skills; able to establish cooperative team environments.
• Demonstrated experience in leading/oversight of diverse teams of study managers (mix of full time and contractor employees), ability to motivate teams.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

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