Director, Biomarker Operations

AbbVie has established and expanded core capabilities in Precision Medicine (PMed), encompassing clinical trial management, translational medicine and companion diagnostics. Within PMed, the Biomarker Program Management (BPM) team connects science and operations to manage biomarker research for multiple Phase1-3 clinical trials. The Director, Biomarker Program Management (BPM), leads the team that connects science and operations to manage biomarker research for the Precision Medicine asset leads (multiple Phase 1-3 clinical trials). This role provides vision for operational and logistical strategies across Precision Medicine to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives.The Director achieves these objectives via scientific expertise, strategic thinking, a global mindset, team building and cross-functional collaboration.

Responsibilities :

• Lead team of Biomarker Project Managers and Sample Operations Managers to facilitate the implementation of Precision Medicine research into AbbVie clinical trials. Provide leadership and mentoring for team members; responsible for developing the expertise of team members. Set a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels.
• Set Vision for Biomarker Program Management efforts for Precision Medicine that enable continuous improvement in processes and efficiency. Explore potential opportunities for expanding services and capabilities of BPM. Identify gaps and spearhead special development projects, as needed.
• Manage biomarker operations and logistics to support the clinical trial schedule. Proactively identify, resolve, mitigate, and/or escalate biomarker study-related risks and issues.
• Assign approved programs to staff members and ensure team is resourced, trained, and employed to start up, manage and close clinical trials. This includes partnering with Clinical Biomarker Leads and being responsible for editing clinical documents, sample management, data management, cross-functional teams, budget management and strategy documents. Programs are executed to meet required timelines, budgets, and regulatory requirements.
• Ensure vendors are managed per AbbVie procedures including selection, contract execution and management.
• Manage budgets, ensuring accurate projections are provided to Finance monthly, quarterly, and yearly, adjusting as appropriate to keep actual variances low.
• Engage with and influence leaders of cross-functional stakeholders within AbbVie to develop operational strategies and infrastructure that enable Precision Medicine efforts. Lead efforts to ensure consistency in operational strategies across the Precision Medicine organization.
• Coordinate training for all staff members to ensure training plans are met.
• Organize department-wide programs such as off-site meetings, as required.
• Apply and adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical
• guidelines.
• Develop direct reports to continue to grow within the organization according to their individualized development plans.

Qualifications :

• Ph.D. Degree with 8 years project management, oncology and/or clinical trial experience or Master's Degree with 10 years project management, oncology and/or clinical trial experience or Bachelor's Degree with 14 years of project management, oncology and/or clinical trial experience
• Excellent oral and written communication skills in English. Expertise in MS Office applications including Excel, Word, and PowerPoint.
• Organization, attention to detail and effective time management with an ability to adapt to changing priorities.
• Excellent analytical and interpersonal skills. Experience interacting with various levels within the organization.
• Proven success leading teams, working collaboratively in a cross-functional environment, and motivating team members to drive toward success
• Effective leadership skills with a proven ability to foster team productivity and cohesiveness. Demonstration of successful coaching/mentoring and direct people management skills
• Project Management certification a plus.
• Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
• Experience working in a quality control and regulatory-rich environment. Experience holding meetings by teleconference and working with colleagues remotely
• Scientific background in and knowledge of life sciences and biomarkers. Exposure to companion diagnostic development a plus.
• Prior people leadership

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Travel: No

Job Type: Experienced

Schedule: Full-time