Oncology Clinical Development Lead — Senior Director

Regulatory Jobs; Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

PTO

Health benefits

401(k)

Long-term incentives

Job summary

AbbVie seeks a senior clinical development leader to design and oversee complex programs, ensuring regulatory compliance and alignment with the overall product development plan. You will guide investigators, study staff, and cross-functional teams while overseeing protocol development, study reports, and regulatory submissions.

You will collaborate with Medical Affairs, Commercial, and Discovery to shape translational strategies and maintain cutting-edge scientific leadership, representing

Qualifications

• Bachelor's degree in the sciences; advanced degree preferred.
• At least 8 years of relevant clinical trial experience in the pharmaceutical industry or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to 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.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills.

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues.
• Oversees project-related education of investigators, study site personnel and AbbVie study staff.
• May have responsibility for leading clinical study teams, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Primary responsibility for and ownership of design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents.
• May oversee the work of appropriate levels of scientific directors working on the same or related programs and may oversee direct reports.
• May serve on or co chair Integrated Evidence Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• Responsibilities may include providing clinical development expertise to appropriate governance forums and/or other cross-functional teams and internal stakeholders.
• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
• May participate in or lead clinical development contributions to due diligence or other business development activity.
• As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Skills

Clinical development leadership

Regulatory compliance

Cross-functional collaboration

English communication

Study protocol design

Education

Bachelor's degree in life sciences

PhD or MD preferred

Job description

AbbVie seeks a senior clinical development leader to design and oversee complex programs, ensuring regulatory compliance and alignment with the overall product development plan. You will guide investigators, study staff, and cross-functional teams while overseeing protocol development, study reports, and regulatory submissions.

You will collaborate with Medical Affairs, Commercial, and Discovery to shape translational strategies and maintain cutting-edge scientific leadership, representing