Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs for Phase 1 studies at AbbVie Clinical Pharmacology Research Unit (ACPRU). Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
- Manages the design and implementation of one or more clinical development programs with respect to Phase 1 and clinical pharmacology studies in support of an 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 AbbVie study staff.
- Principal investigator or sub-investigator for all Phase 1 and clinical pharmacology studies conducted at the ACPRU with oversight of all clinical study activities.
- Responsible for clinical decision-making including eligibility assessment, adverse event adjudication, medical management of enrolled subjects, completion of safety follow-up, and review of safety data (including pharmacokinetics).
- Case report form (CRF) review and approval.
- Review, edit, and act as primary signatory for clinical study reports (CSR’s) for all studies at ACPRU and selected studies performed at other sites.
- Responsible for interacting with central IRB members, concerning protocols, informed consents, and associated documents.
- Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
- Along with ACPRU Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
- Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Responsible for design, analysis, interpretation, and reporting of scientific content of phase 1 protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Provides in-house clinical expertise for the molecule and study volunteers, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
- May participate in due diligence or other business development activity.
- As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
- Effectively present recommendations in cross-functional/group environments based on medical and scientific principles/evidence.
- Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and study volunteers; partners with Development, Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
- Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in clinical pharmacology and the therapeutic areas of interest to AbbVie.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
- May serve as ACPRU representative for key regulatory discussions related to clinical pharmacology studies.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run a clinical research program of moderate complexity with minimal supervision.
- Ability to perform and bring out the best in others on a cross-functional global team.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced