Associate Scientific Director, Oncology Early Development

AbbVie; California (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Clinical Development professional to oversee direction, planning, execution and interpretation of clinical trials within a cross-functional team. You will contribute to protocol design, safety and efficacy interpretation, and regulatory submissions to support product strategy.

With a scientific background and experience in Phase 1 or related trials, you will collaborate across Medical Affairs, Discovery and Commercial groups while ensuring compliance with Good Clinical

Qualifications

• Bachelor's degree in the sciences; advanced degree (MS/PhD) required.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is required.
• Must possess excellent oral and written English communication skills.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.

Responsibilities

• Design and implement first-in-human Phase 1 study protocols for a clinical development program under supervision.
• Review, interpret, and communicate accumulating data on safety and efficacy of the molecule.
• Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses.
• Contribute to the development of a rigorous, cross-functionally-aligned Clinical Development Plan in collaboration with matrix team members.
• Participates in investigator interactions and collaborates with Medical Affairs, Discovery, and other functions.
• Stays abreast of professional information through conferences and literature to augment expertise in the therapeutic area.

Skills

English communication

Cross-functional collaboration

Education

Bachelor's degree in sciences

Advanced degree (MS, PhD)

Job 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 first-in-human (Phase 1) 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 review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables.
• 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 be asked to contribute 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 Discovery Team, 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.

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) required.
• Ability to provide input and direction to clinical research with appropriate supervision.
• Strong desire to collaborate in a cross-functional setting.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is required.
• 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.

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:

• Note: No amount of payis considered to be wages 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 andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html