Medical Director, Hematology Clinical Development

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 product scientific and business strategy.

Responsibilities:
- Manages design and implementation of one or more clinical development programs in support of the Development Plan; oversees project-related education of investigators, study site personnel and AbbVie study staff; may span early translational to mature product lifecycle management.
- Oversees clinical study integrity and review; interprets and communicates accumulating safety/efficacy data; with Clinical Operations, oversees study enrollment and key deliverable timelines; assesses/reports serious adverse events per policy and regulations.
- Responsible for design, analysis, interpretation and reporting of 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 with Discovery to translational strategies.
- May chair a Clinical Sub-team; develops rigorous, cross-functionally-aligned, vetted Development Plan; may supervise matrix team members; serves as Clinical Research representative to Asset Strategy Teams and other cross-functional stakeholders.
- Acts as clinical interface; solicits opinion leader interactions; partners with Medical Affairs/Commercial and others to incorporate cross-functional perspectives into plans/protocols.
- Stays current via conferences, medical literature and training.
- Understands and complies with regulatory requirements for clinical studies/global drug development; serves as clinical representative for key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and other quality standards.

Qualifications:
- M.D. or non-US equivalent with relevant therapeutic specialty (Oncology, Hematology); Oncology residency completion strongly preferred.
- At least 2 years clinical trial experience (pharma industry, academia, or equivalent).
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to perform and bring out the best in others on a cross-functional global team.
- Ability to interact externally/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.

Benefits (as stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees; eligible for long-term incentive programs.

Application instructions:
- None provided in the posting.