Job Description

In collaboration with a therapeutic area, the Scientific Director, Clinical Science will lead the design, conduct, analysis, and reporting of clinical trials. They will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery through the achievement of clinical proof of concept and to supporting the registration and commercialization of a product.     Participates in cross-functional teams to generate, deliver, interpret and communicate high-quality clinical data supporting overall product scientific and business strategy.   This role is based out of our South San Francisco, CA office.

Responsibilities:

Is central to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends conferences, reviews medical literature and undertakes other available training, to develop and augment expertise in therapeutic area

Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and helps to identify and evaluate business development opportunities.

Responsible for providing focused scientific and clinical study support from start-up clinical study report.

Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leaders to build pipeline awareness and foster research collaborations.

Formulates the Clinical Study Brief in collaboration with Discovery, clinical and cross functional colleagues. Contributes to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.

Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.

Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.

May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs. May take some administrative responsibilities, such as organization of internal clinical meetings, small group discussions and selection of candidates for open positions.

May be responsible for onboarding and/or mentoring of new Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs.

Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and actively participates in meetings.

Oversees project-related education of investigators, study site personnel, CRO partners and AbbVie study staff.

Has 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.

In collaboration with regulatory staff, 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.