Executive Director / Vice President, Clinical Operations

Position Summary: The Head of Clinical Operations is responsible for leadership of Clinical Trial Management, Data Management, Study Start-up, and execution of all clinical programs supporting Clinical Development within the R&D organization.

Duties and Responsibilities:

• Responsible for global outsourcing strategy including strategic partnerships/preferred relationships with CROs, vendors, investigators, and other external partners.
• Functional leadership and direct line management for Clinical Trial Management, including mentoring, training, performance evaluation, and career development.
• Oversees clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
• Coordinate with the Head of Data Management to deliver high quality data deliverables on time and on budget.
• Serves as chair for Executive Steering Committee and Joint Operating Committee with CRO partners
• Responsible for overall quality management systems for Clinical Operations including quality oversight, vendor oversight, SOP systems, training, documentation, and GCP compliance.
• Responsible for overseeing all clinical start-up activities including feasibility, country selection/recommendation, budget & timeline planning, supply chain, and regulatory preparation.
• Provides input in development of clinical plans, detailed study plans, synopses, and protocols; member of Clinical Document Review and Approval Committee (CDRAC) and Clinical Development Leadership Team.
• Develops, analyzes, and reports performance metrics for clinical programs. Sets operational performance goals, key performance indicators and targets.
• Responsible for Clinical Operations functional and project budget, forecasting, long-range planning, quarterly reporting with Finance, and Project Management.
• Responsible and accountable for planning and execution of clinical projects: oversight and directional alignment of timelines, budget, and key deliverables as well as contributing to overall clinical strategy.

Education, Skills and Experience Requirements:

• Ability to travel onsite multiple days per week.
• Submission experience required.
• Minimum 15+ years of clinical operations experience in a pharmaceutical, biotech, or CRO setting. Experience in Neuroscience therapeutic area preferred.
• Bachelor’s degree in life sciences required; advanced degree strongly preferred.
• Willingness to travel domestically and internationally up to 20%.
• Excellent interpersonal and communications skills, both verbal and written.
• Excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials, inspection experience preferred.
• Strong interpersonal, organizational, and multi-tasking skills.
• Effective leadership and strong management abilities, with preferably five or more years prior experience managing, mentoring, and training Clinical Operations staff.
• Extensive vendor oversight and management experience, including negotiations and contract execution.
• International trial execution experience required.

About Us

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com

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.