Scientific Director, Oncology Clinical Development
About The Position
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities for a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting the product’s scientific and business strategy. Manages the design and implementation of one or more clinical development programs within an overall Product Development Plan, applying medical and scientific principles and knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues. Oversees project-related education for investigators, study site personnel, and AbbVie study staff. Has overall responsibility for clinical study oversight, including monitoring study integrity and reviewing, interpreting, and communicating accumulating safety and efficacy data. In partnership with Clinical Operations, oversees study enrollment and timelines for key deliverables. Responsible for the design, analysis, interpretation, and reporting of scientific content in protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee Associate Scientific Directors and/or Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating scientific activities with internal stakeholders. May participate in due diligence or other business development activities and, as program needs require, partner with Discovery colleagues on translational strategies. May serve on an Integrated Evidence Strategy Team, developing a rigorous, cross-functionally aligned and vetted Clinical Development Plan that considers contingencies and alternative approaches. Acts as a clinical interface and solicits opinion leader interactions related to the molecule and disease area, partnering with Medical Affairs, Commercial, and other functions as required and consistent with corporate policies. Maintains professional and therapeutic-area expertise through conferences, medical literature, and other training. Understands regulatory requirements for clinical studies and global drug development, complies with those requirements, and serves as a clinical representative in key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards. AbbVie describes its mission as discovering and delivering innovative medicines and solutions for serious health issues, with work across areas including immunology, oncology, and neuroscience. The position is eligible for long-term incentive programs. Eligible employees are offered paid time off, medical, dental, and vision insurance, and a 401(k).
Requirements
- Bachelor’s degree in the sciences.
- At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to provide input and direction to clinical research with appropriate supervision.
- Ability to oversee 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 and regulatory and compliance requirements governing clinical trials.
- Experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.
Nice To Haves
- Advanced degree, such as an MS, PhD, or PharmD.
Responsibilities
- Manage the design and implementation of one or more clinical development programs in support of the overall Product Development Plan.
- Oversee project-related education of investigators, study site personnel, and AbbVie study staff.
- Oversee clinical studies, monitor study integrity, and review, interpret, and communicate accumulating safety and efficacy data.
- Partner with Clinical Operations to oversee study enrollment and timelines for key deliverables.
- Design, analyze, interpret, and report scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- May oversee Associate Scientific Directors and/or Clinical Scientists working on the same or related programs.
- Provide in-house clinical expertise for the molecule and disease, coordinating scientific activities with internal stakeholders.
- May participate in due diligence or other business development activities.
- As required by program needs, partner with Discovery colleagues on translational strategies.
- May serve on an Integrated Evidence Strategy Team and develop a rigorous, cross-functionally aligned Clinical Development Plan that considers contingencies and alternative approaches.
- Act as a clinical interface and solicit opinion leader interactions, partnering with Medical Affairs, Commercial, and other functions as appropriate and consistent with corporate policies.
- Maintain professional and therapeutic-area expertise through conferences, medical literature, and other training.
- Understand and comply with regulatory requirements for clinical studies and global drug development; serve as a clinical representative in key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligible to participate in long-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
