Senior Project Representative, DMPK (Associate Director / Director)
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 .
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company with a mission to develop innovative therapies to address the world's most complex and serious diseases. AbbVie employs approximately 47,000 people worldwide and markets medicines in more than 175 countries.
The AbbVie portfolio consists of several marketed products in areas including eye-care, Immunology, Oncology, Virology, and Women's Health as well as a pipeline containing multiple promising new molecules being studied in hundreds of clinical trials or advancing from Discovery into Development. AbbVie is a global organization with US research sites in Boston (Worcester, MA), Chicago (North Chicago, IL), and the San Francisco Bay Area. This is a remote position, with travel to Chicago, Boston, and San Francisco.
The Drug Metabolism, Pharmacokinetics, and Bioanalysis (DMPK-BA) group is searching for a senior leader with extensive experience as a project representative to provide small molecule project support across all therapeutic areas for compounds in discovery and clinical development. The position requires close collaboration with Discovery and Development project teams, clinical pharmacology, and other stakeholders, developing and executing DMPK-BA strategies necessary to facilitate the advancement our pipeline.
- Develop and drive the DMPK-BA strategy for discovery and clinical development projects to support decisions and milestone transitions
- Serve as a DMPK-BA representative on project teams and collaborate with project team members (e.g., Discovery, Clinical Pharmacology, Clinical Development, Pre-clinical Safety) and groups within DMPK-BA to generate relevant data to support compound progression.
- Effectively communicate DMPK-BA strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions
- Demonstrate thorough understanding of the DMPK-BA aspects necessary for the characterization of modalities to support regulatory submissions.
- Coordinate and request DMPK-BA studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times
- Serve as a liaison with bioanalytical groups to ensure timely reagent generation, method development and sample analysis
- Mentor junior project reps within the global DMPK-BA organization in approaches and best practices, ensuring that support is aligned with project and functional deliverables
- Prepare DMPK-BA sections of regulatory documents (IB, IND, BLA, NDA); provide responses to regulatory questions and ensure generation of appropriate reports
- Bachelor with extensive (at least 16-18 years) experience, Masters with substantial (at least 14-16 years) experience, or Doctorate (Ph.D.) with at least 8-10 years of experience in the pharmaceutical or biotechnology industries
- Experience independently representing DMPK on project teams is required
- Established leader in the field of DMPK with a broad understanding of all disciplines within DMPK and expert in one or more of the following areas: in vitro ADME, pharmacokinetics, transporter, DDI, translational modeling, biotransformation, biomarker strategy
- Demonstrated scientific leadership including generating original scientific investigative strategies and guiding those efforts to an effective and productive outcome
- Recognized expert in his/her discipline
- Demonstrated publication record; lead/senior author contributions a plus
- Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment
- Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver
- High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills
- Passion for data analysis, solving technical problems and applying new technologies to further scientific goals
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 where indicated
- 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
Level and compensation will be commensurate with experience
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)
Yes, 5 % of the Time
Job Level Code
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.