Associate Director, Biomarker Program Management

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:   The Precision Medicine Oncology (PMed-Onc) organization at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to advance AbbVie’s innovative Oncology pipeline.   The Associate Director, Biomarker Program Management, (BPM) leads a team that connects science and operations to manage biomarker research for the PMed-Onc program (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. The Associate 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 PMed-Onc 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 to team 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.  Will directly manage key clinical projects within PMed-Onc.
• 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.  Manage PMed-Onc budgets, ensuring accurate projections are provided to Finance monthly, quarterly, and yearly, adjusting as appropriate to keep actual variances low.  
• Help set Vision for Biomarker Program Management group that enables 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.
• Serve as liaison with leaders of cross-functional stakeholders within AbbVie to enable alignment for PMed-Onc efforts.  Responsible for mentoring personnel in other Therapeutic Areas in Precision Medicine to drive consistency within and between groups.   
• Apply and adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines.  
   

Qualifications

Qualifications:
Basic:

• 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 as well as vendors.
• Proven success in running meetings, working collaboratively in a cross-functional environment, and driving for success
• Effective people management and leadership skills with a proven ability to foster team productivity and cohesiveness.  

Preferred:

• PMP certification desired.  PgMP 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 oncology and biomarkers.  Exposure to companion diagnostic development.

Key Leadership Competencies:

• Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance
• Learns fast, grasps the “essence” and can change course quickly when required
• Raises the bar and is never satisfied with the status quo
• Creates a learning environment, open to suggestions and experimentation for improvement
• Embraces the ideas of others, nurtures innovation and manages innovation to reality
• Thinks beyond the program being managed to the strategy and operations of the broader Translational Oncology organization and the Development division
• Act as a thought leader and mentor for team members; seek to develop the skillsets of others
   

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.