Scientific Director I, Oncology Early Development

BioSpace; South San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Long-term incentives

Paid time off

401(k)

Job summary

AbbVie is seeking a clinical development professional to oversee direction, planning, execution and interpretation of clinical trials in hematology, solid tumors or cell therapy. You will participate in cross-functional teams to deliver high-quality data supporting product strategy.

You will supervise 1-2 studies, monitor data for safety and efficacy, manage timelines, and contribute to study protocols, regulatory submissions and reports.

Qualifications

• 5+ years of clinical trial experience in pharma/biotech or academia.
• Experience overseeing global or multi-site clinical programs.
• Knowledge of regulatory and compliance requirements governing clinical trials.

Responsibilities

• Oversee design and execution of one or more clinical development programs.
• Monitor data integrity, safety and efficacy across studies.
• Ensure timelines and deliverables align with product development plans.
• Prepare and review protocols, Investigator Brochures and Clinical Study Reports.
• Coordinate with CROs and internal stakeholders on trial activities.
• Maintain knowledge of regulatory expectations and engage with regulatory discussions.

Skills

Clinical trial experience

Cross-functional teamwork

Regulatory knowledge

English communication

Supervision of research

Education

Bachelor's in sciences

Advanced degree preferred (MS/PhD/PharmD)

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

Purpose

Job Description

Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program in hematology, solid tumors or cell therapy. 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, AbbVies 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 1-2 clinical studies, monitoring overall study integrity and responsibility for data review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Overall responsibility for data review / medical monitoring to ensure quality data for both in-house and outsourced studies.
• Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• 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 Scientific Directors and/or of Clinical Scientists working on the same or related programs; provide oversight of Contract Research Organization (CRO) and other vendors on the trials
• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific 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.
• Will serve on an Asset Study Team (AST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• 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

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.
• Ability to provide input and direction to clinical research with appropriate supervision.
• At least 5+ years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to oversee 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 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 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 employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys 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.

US & Puerto Rico only - to learn more, visit https://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