BioSpace
Medical Director, Clinical Development - Oncology
BioSpace, Florham Park, New Jersey, us, 07932
Medical Director, Clinical Development - Oncology
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Company Description
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. Our therapeutic areas include immunology, oncology, neuroscience, and eye care.
Job Description
With supervision, 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 overall product scientific and business strategy.
Responsibilities
Manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles.
Oversees study‑related education of investigators, site personnel, and study staff.
Reviews overall study integrity, accumulating safety and efficacy data, and reports serious adverse events per corporate policy.
Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, investigator brochures, clinical study reports, regulatory submissions, and other program documents.
Serves as the clinical representative for protocols and contributes to the development of a rigorous, cross‑functional Clinical Development Plan.
Participates in opinion leader interactions related to the disease area(s) and partners with Medical Affairs, Commercial, and other functions in these activities.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and all other quality standards.
Qualifications
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non‑US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Residency strongly preferred; fellowship desirable.
Ability to run a clinical research study with appropriate supervision.
Strong desire to collaborate in a cross‑functional setting.
Experience in the design of study protocols, clinical trial methodology, regulatory and compliance requirements, and clinical trial industry experience preferred.
Excellent oral and written English communication skills.
Benefits
Paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Eligibility to participate in short‑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.
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Company Description
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. Our therapeutic areas include immunology, oncology, neuroscience, and eye care.
Job Description
With supervision, 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 overall product scientific and business strategy.
Responsibilities
Manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles.
Oversees study‑related education of investigators, site personnel, and study staff.
Reviews overall study integrity, accumulating safety and efficacy data, and reports serious adverse events per corporate policy.
Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, investigator brochures, clinical study reports, regulatory submissions, and other program documents.
Serves as the clinical representative for protocols and contributes to the development of a rigorous, cross‑functional Clinical Development Plan.
Participates in opinion leader interactions related to the disease area(s) and partners with Medical Affairs, Commercial, and other functions in these activities.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and all other quality standards.
Qualifications
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non‑US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Residency strongly preferred; fellowship desirable.
Ability to run a clinical research study with appropriate supervision.
Strong desire to collaborate in a cross‑functional setting.
Experience in the design of study protocols, clinical trial methodology, regulatory and compliance requirements, and clinical trial industry experience preferred.
Excellent oral and written English communication skills.
Benefits
Paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Eligibility to participate in short‑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.
#J-18808-Ljbffr