Head of Data Management and Analysis
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.
Since 2013, AbbVie has expanded its commitment to the San Francisco Bay Area, now represented by three facilities in Redwood City, South San Francisco, Sunnyvale and a future new Bay Area headquarters in South San Francisco. AbbVie employees in the Bay Area drive AbbVie’s research-based, innovation driven missions in healthcare. Specifically, Bay Area employees bring deep scientific expertise and commercial excellence to advance cancer care. Current oncology areas of focus include immuno-oncology, tumor targeting, tumor dependency and precision medicine. With facilities positioned in the heart of the biotechnology industry, we are able to collaborate with the best and brightest minds in oncology.
With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and Abbvie study staff. Responsibility will focus on early clinical development program activities but may extend to later stage development activities and product lifecycle management strategies for internal programs
Key Responsibilities Include:
- Responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables.
- Contributes to design, analysis, interpretation and reporting of scientific content of protocols, investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
- May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development plan in collaboration with matrix team members.
- Participates in opinion leader interactions related to the disease area(s); partners with Research, Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies.
- Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- PharmD/PhD with 4+ years pharmaceutical industry experience.
- Oncology development experience, specifically early development, is highly preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Clinical of early phase clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
- Ability to interact externally and internally to support global scientific and business strategy.
- Must possess excellent oral and written English communication skills.
Significant Work Activities
Yes, 10 % 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.