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:
- Manages design and implementation of one or more clinical development programs aligned to an overall Development Plan; oversees project-related education for investigators, study site personnel and AbbVie staff; may span translational development to product lifecycle management.
- Oversees clinical studies: monitors integrity; reviews, interprets, and communicates accumulating safety and efficacy data; with Clinical Operations, oversees enrollment and timelines; assesses and reports serious adverse events per policy and regulations.
- Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May oversee Associate Medical/Scientific Directors and Clinical Scientists.
- Provides in-house clinical expertise; coordinates scientific/medical activities with internal stakeholders; may participate in due diligence/business development; contributes to translational strategy with Discovery.
- May serve on/chair a Clinical Sub-team to develop a vetted, cross-functionally aligned Development Plan; may supervise matrix team members and serve as Clinical Research representative to cross-functional teams.
- Acts as clinical interface; solicits opinion leader interactions; partners with Medical Affairs/Commercial and other functions.
- Stays current via conferences, literature and training.
- Ensures understanding and compliance with regulatory requirements; represents Clinical on key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and quality standards.
Qualifications:
- M.D. or non-US equivalent with relevant specialty (Oncology, Hematology); Oncology residency strongly preferred.
- At least 2 years clinical trial experience.
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to lead and support a cross-functional global team.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience designing clinical strategy and study protocols.
- Excellent oral and written English communication.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.