Medical Director, Clinical Development - Hematology

BioSpace; North Chicago (IL); On-site; USD 240,000 - 320,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Job summary

A leading biopharmaceutical company in North Chicago is seeking an experienced Medical Director in Clinical Development to oversee clinical trials and manage a clinical development program. The ideal candidate will hold an M.D. or equivalent, have significant clinical trial experience, and bring strong leadership and communication skills. This role offers a competitive salary and a comprehensive benefits package.

Qualifications

• At least 2 years of clinical trial experience in the pharmaceutical industry or academia.
• Ability to run a clinical research program of moderate complexity.
• Strong knowledge of clinical trial methodology and regulatory requirements.
• Strong knowledge of clinical trial methodology and regulatory requirements.
• Excellent English communication skills (oral and written).

Responsibilities

• Manage the design and implementation of clinical development programs.
• Oversee clinical studies and ensure compliance with regulations.
• Act as a clinical interface and engage with opinion leaders.
• Mentor junior clinicians and collaborates with regulatory submissions.
• Ensure compliance with Good Clinical Practices and regulatory standards.

Skills

Clinical trial management

Cross-functional leadership

Regulatory compliance

Excellent communication skills

Regulatory knowledge

Education

Medical Doctor (M.D.) or non-U.S. equivalent

Completion of residency program

Subspecialty fellowship

Job description

Medical Director, Clinical Development - Hematology

Company Description: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care—and in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com.

Job Description: Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross‑functional teams to generate, deliver, and interpret high‑quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• Manages the design and implementation of one or more clinical development programs in support of an 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.
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Works with Clinical Operations to oversee study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
• Responsible for 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 Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
• Provides in‑house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in 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.
• May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross‑functionally‑aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT) and ADT Leadership Board (ALB).
• Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; 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.
• 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 all other quality standards in conducting research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non‑U.S. equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run 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, 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.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short‑term incentive programs.
• This job is eligible to participate in our long‑term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.