Medical Director, Oncology Clinical Development (Solid Tumors)

Allergan; South San Francisco (CA); On-site; USD 190,000 - 240,000; Full time

Job summary

AbbVie in South San Francisco is seeking an experienced physician-scientist to supervise and guide clinical development programs. You will participate in cross-functional teams to generate and interpret high-quality clinical data that support product strategy.

With supervision, you will design study protocols, oversee enrollment and data integrity, and contribute to regulatory submissions while staying current with the latest clinical science and regulatory expectations.

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 completion preferred; subspecialty fellowship desirable.
• Ability to run a clinical research study with appropriate supervision.
• Strong desire to collaborate in a cross-functional setting.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
• Ability to interact externally and internally to support global scientific and business strategy.
• Must possess excellent oral and written English communication skills.

Responsibilities

• Design and implement study protocols for a clinical development 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.
• Oversee study integrity, data interpretation, and communication of safety and efficacy data; manage enrollment and timelines for key deliverables.
• Contribute to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• May serve on a Clinical Strategy Team as the clinical representative for assigned protocols.
• Participate in opinion leader interactions related to the disease areas; collaborate with Medical Affairs, Commercial and other functions.
• Stay abreast of professional information and technology through conferences, literature, and training.
• Ensure adherence to Good Clinical Practices and pharmacovigilance standards and to quality procedures.

Skills

Clinical trial experience

Cross-functional collaboration

English communication

Education

MD/DO or equivalent

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:

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:

• With appropriate supervision, 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, 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 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.
• Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. Contributes to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
• Participates in 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.
• 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. May be asked to contribute to regulatory responses and 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.
• Ability to run a clinical research study with appropriate supervision.
• Strong desire to collaborate in a cross-functional setting.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
• Ability to interact externally and internally to support global scientific and business strategy.
• 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolute dis...

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