Associate Director, Biomarker Program Management
AbbVie
Summary
The Precision Medicine (PMed) Immunology and Neuroscience organization at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to advance AbbVie's innovative Immunology and Neuroscience pipeline. The Associate Director, Biomarker Program Management, leads a team within the Immunology and Neuroscience therapeutic area that connects science and operations to manage biomarker research for multiple Phase 1-3 clinical trials. This role provides vision for operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives.
Job description
Responsibilities
- Lead team of Biomarker Project Managers and Sample Operations Managers to facilitate the implementation of PMed research into AbbVie clinical trials.
- Provide management 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.
- Assign approved programs and trials to team members and ensure team members are resourced, trained, and employed to start up, manage and close clinical trials.
- Partner with PMed Biomarker Leads and be responsible for editing clinical documents, sample management, data management, cross-functional teams, budget management and strategy documents.
- Manage biomarker operations and logistics to support the clinical trial schedule.
- Proactively identify, resolve, mitigate, and/or escalate biomarker study-related risks and issues.
- Ensure vendors are managed per AbbVie procedures including selection, contract execution and management.
- Assist in the management of Oncology budgets, ensuring accurate projections are provided to Finance monthly, quarterly, and yearly.
- Help set vision for Biomarker Program Management group that enables continuous improvement in processes and efficiency.
- Serve as liaison with leaders of cross-functional stakeholders within AbbVie.
- Apply and adhere to ICH/GCP, biosample storage procedures, biosample management best practices and ethical guidelines.
Qualifications
- Ph.D. Degree with 8+ years project management, life science and/or clinical trial experience or Master's Degree with 10+ years project management, life science and/or clinical trial experience or Bachelor's Degree with 14+ years of project management, life science and/or clinical trial experience.
- Excellent oral and written communication skills in English.
- Expertise in MS Office applications including Excel, Word, Project 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 as well as vendors.
- Proven success in running meetings, working collaboratively in a cross-functional environment, and driving for success.
- 3+ years of people management experience.
- Effective people management and leadership skills with a proven ability to foster team productivity and cohesiveness.
Preferred
- PMP certification desired.
- Competent in application of standard business procedures (standard operating procedures, 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 and knowledge of biomarkers.
- Exposure to companion diagnostic development.
- Knowledge of image data and associated testing.
Requirements
- Ph.D. Degree with 8+ years project management, life science and/or clinical trial experience or Master's Degree with 10+ years project management, life science and/or clinical trial experience or Bachelor's Degree with 14+ years of project management, life science and/or clinical trial experience
- Excellent oral and written communication skills in English
- Expertise in MS Office applications including Excel, Word, Project 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 as well as vendors
- Proven success in running meetings, working collaboratively in a cross-functional environment, and driving for success
- 3+ years of people management experience
- Effective people management and leadership skills with a proven ability to foster team productivity and cohesiveness
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.