Senior Medical Director, Hematology Clinical Development
Waltham, Massachusetts, United States · On-site
$182k–$346k/yr
Mid level
Company Description About AbbVie 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 r…
Skills: Clinical Trial Design, Clinical Development Planning, Regulatory Compliance, Pharmacovigilance, Good Clinical Practices
Company Description About AbbVie At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables,…
Senior Medical Director, Hematology Clinical Development
Florham Park, New Jersey, United States · On-site
$182k–$346k/yr
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Company Description About AbbVie 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 r…
Skills: Clinical Trial Design, Clinical Development Planning, Regulatory Compliance, Pharmacovigilance, Good Clinical Practices
Senior Medical Director, Hematology Clinical Development
North Chicago, Illinois, United States · On-site
$182k–$346k/yr
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Company Description About AbbVie 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 r…
Skills: Clinical Trial Design, Clinical Development Planning, Regulatory Compliance, Pharmacovigilance, Good Clinical Practices
Company Description About AbbVie 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 r…
Skills: HEOR Strategy, Clinical Development, Cross-functional Leadership, Health Economics, Outcomes Research
South San Francisco, California, United States · On-site
$161k–$305k/yr
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Company Description About AbbVie 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 r…
Skills: HEOR Strategy, Clinical Research, Cross-functional Leadership, Health Economics, Outcomes Research
Company Description About AbbVie 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 r…
Skills: HEOR Strategy, Clinical Research, Cross-functional Leadership, Health Economics, Outcomes Research
Company Description About AbbVie 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 r…
Skills: HEOR Strategy, Clinical Development, Cross-functional Leadership, Health Economics, Outcomes Research
Company Description About AbbVie 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 r…
Skills: HEOR Strategy, Clinical Research, Cross-functional Leadership, Health Economics, Outcomes Research
Company Description About AbbVie 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 r…
Senior Counsel, Global Commercial Legal - Oncology
Waltham, Massachusetts, United States · Hybrid
$161k–$305k/yr
Senior
Company Description About AbbVie 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 r…
Senior Counsel, Global Commercial Legal - Oncology
Waltham, Massachusetts, United States · Hybrid
$161k–$305k/yr
Senior
Company Description About AbbVie 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 r…
Business Analyst/System Administrator – Business Continuity
North Chicago, Illinois, United States · On-site
$66k–$126k/yr
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Company Description About AbbVie 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 r…
Skills: Business Analysis, System Administration, Data Reporting, Microsoft Excel, Power BI
North Chicago, Illinois, United States · Remote OK
$85k–$162k/yr
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Company Description About AbbVie 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 r…
Skills: Okta, Microsoft Entra ID, Ping Federate, SAML 2.0, OIDC
Company Description About AbbVie 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 r…
Skills: Medical Affairs Strategy, People Management, Clinical Trial Design, Evidence Generation, Stakeholder Engagement
Company Description About AbbVie 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 r…
Responsable de domaine thérapeutique, Soins spécialisés
Montreal, Quebec, Canada · On-site
Senior+
Description de l'entreprise About AbbVie AbbVie a pour mission de découvrir et d’offrir des solutions et des médicaments novateurs pour répondre à des besoins importants en matière de santé aujourd’hui et relever les déf…
Skills: Medical Affairs Strategy, People Management, Clinical Trial Design, Evidence Generation, Stakeholder Engagement
Company Description About AbbVie 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 r…
Skills: Medical Affairs Strategy, People Management, Clinical Trial Design, Evidence Generation, Stakeholder Engagement
Company Description About AbbVie 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 r…
Director, Regulatory Affairs - Oncology Early Development
South San Francisco, California, United States · On-site
$161k–$305k/yr
Senior
Company Description About AbbVie 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 r…
Skills: Global Regulatory Strategy, Oncology Drug Development, Health Authority Interaction, Project Management, Regulatory Submission
Senior Medical Director, Hematology Clinical Development
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$182k–$346k/yr
Full-time
postgraduate degree
Paid Time Off, Vacation, Holidays, Sick Leave, Medical Insurance, Dental Insurance
Posted 32d ago
~40 hrs/week
Responsibilities
Oversees the planning, execution, and interpretation of clinical trials within hematology development programs to support product scientific and business strategies. Manages the design of clinical protocols and ensures the safety and efficacy of molecules through rigorous data review and regulatory compliance.
Requirements
Requires an M.D. or D.O. degree with a relevant therapeutic specialty and at least 2 years of clinical trial experience in pharma or academia. Candidates must possess strong knowledge of clinical trial methodology and excellent English communication skills.
Full job description
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Job Description
Purpose:
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. Along with Clinical Operations, is responsible for oversight of 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 Medical Directors 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), 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 to all other quality standards in conducting research.
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. 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
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 thisposting 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 long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical