AbbVie

Associate Director, Biomarker Program Management

Posted on: 11 Mar 2021

North Chicago, IL

Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.

Associate Director, Biomarker Program Management

North Chicago, IL

Purpose: The Precision Medicine Neuroscience (PMed-Neuro) organization at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to advance AbbVies innovative Neuroscience pipeline. The Associate Director, Biomarker Program Management, (BPM) leads a team that connects science and operations to manage biomarker research for the PMed-Neuro 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-Neuro 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-Neuro.
* 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-Neuro 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-Neuro efforts. Responsible for collaborating with 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, neuroscience or other life science and/or clinical trial experience or Masters Degree with 10+ years project management, neuroscience or other life science and/or clinical trial experience or Bachelors Degree with 14+ years of project management, neuroscience or other life science 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 neuroscience or other life science and biomarkers. Exposure to companion diagnostic development. Knowledge of image data relevant to neuroscience and associated testing.

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 Precision Medicine organization and the Development division
* Act as a thought leader and mentor for team members; seek to develop the skillsets of others

**Equal Opportunity Employer Minorities/Women/Veterans/Disabled**

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
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.

AbbVie

Chicago, IL

AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.

It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.

Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.