Associate Director, Clinical Scientist

In collaboration with a therapeutic area Medical Director or Scientific Director, the Clinical Scientist will lead the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist 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 to supporting the registration and commercialization of a product. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities;

• Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
• 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.
• Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
• 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.
• Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
• 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.
• 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.
• 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

Oversees project-related education of investigators, study site personnel 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.

Qualifications:

• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
• Strong track record of collaboration in a cross-functional setting.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols
• Must possess excellent oral and written English communication skills.
• Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
• Ability to interact externally and internally to support global scientific and business strategy.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.