AbbVie Associate Scientific Director, Oncology Early Development in Redwood City, California
Associate Scientific Director, Oncology Early Development
USA, California, Redwood City
2 additional locations
Research & Development
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Biotherapeutics, AbbVie's immuno-oncology center in Redwood City, CA.
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.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled