Director, Clinical Data Sciences

Alkermes Overview

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global  biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

POSITION SUMMARY:

Responsible for leading and mentoring the Clinical Data Management, Clinical Data Standards and Governance, and Clinical Data Sciences teams.  Responsible for teams who design, test, and maintain, and grant access to all clinical data collection systems, following a Risk Based Monitoring (RBM) operational framework, generating impactful data insights and implementing effective RBM, Data Quality Oversight, and Clinical Data Management best practices day-to-day with study teams across Alkermes’ portfolio of products, conforming to data regulations (i.e., FDA CFR, ICH E6, GDPR) from study start-up through to CSR/submission.

 Duties and Responsibilities:

• Supervisory and leadership responsibilities for all data management and back-end activities supporting Alkermes clinical programs from DM strategy, database start-up through database lock and CSR/submission.
• Supervisory leadership of a team of Data Scientists in support of RBM and DQO activities for studies, programs and/or across the clinical development portfolio.
• Provide oversight and guidance to teams responsible for data discovery and review processes, interpreting data signals/trends, facilitating discussion and follow-up/actions to address impactful findings with clinical study teams, program teams or Senior Leadership teams to support data quality and audit-readiness.
• Manages relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships, providing oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.
• Participate in clinical trial systems strategy/development initiatives including systems and technology integration, data sharing, access and storage including but not limited to EDC, IxRS, ePRO, eSource, Alkermes’ clinical data lake and Tableau.
• Leads the development, refinement and enhancement of Alkermes’ Risk Based Monitoring and Data Quality Oversight framework, to be utilized across Alkermes’ portfolio of products, in conjunction with Clinical Quality and appropriate functions.   
• Influences cross-functional teams (study, program level) to adopt fit for purpose processes, standards, systems and roles, based on industry best practices (i.e., CDISC, Transcelerate RACT) and data regulations (i.e., FDA CFR, ICH E6, GDPR) from study start-up through to CSR/submission.

• Champion efficient industry best practices; promote technical innovation. Facilitates change management activities and training for key systems and processes including SOP and business process development.
• Participate as subject matter expert in vendor audits for clinical data systems and represent the technical vendor oversight process in audits in meeting ALKS Data Quality and/or Data Privacy/Integrity requirements and industry regulations (i.e., GDPR).
• Direct people management responsibilities including performance evaluations, goal setting, career development, and departmental growth

Qualifications:

• Data Science and/or Computer Systems/IT background; BS required, MS preferred
• Minimum 10 years (5-7 years supervisory/leadership) experience in a pharmaceutical/biotech setting preferred
• Advanced experience in data management, data sciences, or related lead data review roles, including expertise in database design, data standards, EDC platforms, RBM tools/systems
• Advanced knowledge of RBM or DQO standards (i.e., Transcelerate RACT) or systems (i.e., Cluepoints) as well as Data Privacy/Integrity regulations (i.e., GDPR)
• Advanced knowledge of ICH standards, 21 CFR Part 11, CDISC, data reporting and submission requirements
• Strong auditing/data review experience in assessing vendors’ systems, data flow and identifying risks/mitigation in the data flow
• Strong leadership skills and demonstrated ability and drive cross-functional teams

• Demonstrated risk-based data review, systems or monitoring experience; demonstrated ability to apply in review of clinical trial data
• Strong business analysis and project management skills, professional attitude, focusing on process and quality data improvements
• Excellent written and oral presentation skills and ability to communicate effectively to other data scientists, programmers and non-technical colleagues
• Ability to be collaborative and to mentor other data scientists, along with guiding the organization in the discipline of data sciences
• Strategic mindset with the ability to influence without direct authority, form sound opinions and make sensible decisions in a dynamic environment

Physical Demands and Work Environment:

• Travel domestic and international – up to 20%
• In-house position based in Waltham, MA.  Remote candidates may be considered.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.