Purpose:
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan; oversee project-related education for investigators, study site personnel, and AbbVie study staff.
- Oversee clinical studies, including study integrity and review/interpretation/communication of accumulating safety and efficacy data; oversee study enrollment and timelines for key deliverables (with Clinical Operations).
- Design, analyze, interpret, and report scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May oversee Associate Scientific Directors and/or Clinical Scientists.
- Provide in-house clinical expertise for the molecule and disease; coordinate scientific activities internally; may participate in due diligence/business development; contribute to translational strategies with Discovery as needed.
- May serve on an Integrated Evidence Strategy Team (IEST) to develop a vetted Clinical Development Plan.
- Act as clinical interface; solicit opinion leader interactions and partner with Medical Affairs, Commercial, and others to incorporate cross-functional perspectives into plans and protocols.
- Stay current via conferences, medical literature, and training.
- Understand and comply with regulatory requirements; serve as clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards.
Qualifications:
- Bachelorβs degree in sciences; MS/PhD/PharmD preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- 5+ years clinical trial experience in pharmaceutical industry, academia, or equivalent.
- Ability to oversee a moderate-complexity clinical research program with minimal supervision.
- Ability to lead effectively on cross-functional global teams.
- Ability to interact externally and internally to support global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.