Senior Medical Director, Clinical Development
4 weeks ago
Job Title: Senior Medical Director, Clinical Development
Company: AbbVie
Location: Illinois (hybrid, 3x per week onsite)
Job Type: Full-time
About Us: AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues.
Job Summary: We are seeking a highly experienced Senior Medical Director to lead our clinical development program. The successful candidate will oversee the direction, planning, execution, and interpretation of clinical trials or research activities.
Responsibilities:
- Manage the design and implementation of one or more clinical development programs.
- Oversee project-related education of investigators, study site personnel, and AbbVie study staff.
- Responsible for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data.
- Collaborate with Clinical Operations to oversee study enrollment and overall timelines for key deliverables.
- Responsible for assessment and reporting of serious adverse events.
- Design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses.
- Proactive monitoring of clinical trial safety in collaboration with the ABV CTPS.
- Evaluate all safety data generated in clinical trials and respond to safety questions from investigator sites and IRBs.
- May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- Provide in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders.
- May participate in due diligence or other business development activity.
- Contribute to the design and implementation of translational strategies in partnership with Discovery colleagues.
- May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan.
- Act as a clinical interface and actively solicit opinion leader interactions related to the molecule and disease area.
- Stay abreast of professional information and technology through conferences, medical literature, and other available training.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality standards in conducting research.
Qualifications:
- M.D. or equivalent (D.O.) and completion of an Oncology Residency, Board certification (or equivalent in ex-US countries) preferred.
- 5-7 years of experience in medical monitoring of clinical trials is required or having relevant clinical development/pharma experience would be considered.
- Track record of successful management of product safety matters (labeling negotiation, etc.) preferred.
- Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports, and company core safety information highly desirable.
- Advanced analytical skills.
- Basic leadership and decision-making skills.
- Advanced communication skills.
- Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials.
- Basic clinical and/or drug development expertise.
- Good organizational and prioritization skills.
- Intermediate skill in strategic thinking and planning activities.
- Basic negotiation skills and capabilities to influence.
- Good interpersonal skills (i.e., team player).
- Intermediate computer skills (MS Office); knowledge of ARGUS and Business Objects is a plus.
- Working knowledge of MedDRA.
- Basic statistics and Pharmacoepidemiology.
- Ability to work with limited supervision.
- Ability to establish sound working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds.
- Flexibility and ability to adapt and learn quickly.
- Ability to work under pressure and to tight deadlines.
- Must possess excellent oral and written English communication skills.
- Willing to travel 20%.
Additional Information:
The compensation range for this role is $195,000 - $371,000. AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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