Associate Scientific Director, Oncology Early Development

Employer
AbbVie
Location
Redwood City, CA, US
Posted
Sep 18, 2019
Ref
1906275
Discipline
Science/R&D, Oncology
Required Education
Bachelors Degree
Position Type
Full time
In AbbVie Oncology Early Development (OED), we strive to develop a rich and innovative pipeline of transformative cancer therapies by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners - scientists, clinical experts, industry peers, and patients - to discover and develop medicines that drive groundbreaking improvements in cancer treatment.

We are growing our team and are seeking an Associate Scientific Director for our Redwood City, CA site. In this position you will manage the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, oversee 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
Detailed responsibilities include:
  • 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.
  • Contributing 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 contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development plan in collaboration with matrix team members.
  • Participating 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.
  • Staying abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
  • Understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May provide support with regulatory responses and discussions.
  • Ensuring adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

  • Bachelor's/Master's degree in Science related to field with 11+ years or 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.
  • 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 design of study protocols is desirable.
  • Ability to interact externally and internally to support global scientific and business strategy.
  • Excellent oral and written English communication skills.