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Scientific Director, Clinical Scientist, Oncology Early Development
4 months ago
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
In collaboration with a therapeutic area, the Scientific Director, Clinical Science will lead the design, conduct, analysis, and reporting of clinical trials. They will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery through the achievement of clinical proof of concept and to supporting the registration and commercialization of a product. Participates in cross-functional teams to generate, deliver, interpret and communicate high-quality clinical data supporting overall product scientific and business strategy. This role is based out of our South San Francisco, CA office.
Responsibilities;
•Is central to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends conferences, reviews medical literature and undertakes other available training, to develop and augment expertise in therapeutic area
•Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and helps to identify and evaluate business development opportunities.
• Responsible for providing focused scientific and clinical study support from start-up clinical study report.
• Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leaders to build pipeline awareness and foster research collaborations.
• Formulates the Clinical Study Brief in collaboration with Discovery, clinical and cross functional colleagues. Contributes to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
• Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
• Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
• May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs. May take some administrative responsibilities, such as organization of internal clinical meetings, small group discussions and selection of candidates for open positions.
• May be responsible for onboarding and/or mentoring of new Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs.
•Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and actively participates in meetings.
Oversees project-related education of investigators, study site personnel, CRO partners 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.
•In collaboration with regulatory staff, 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.
Qualifications
Qualifications
Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
•Strong track record of collaboration 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
•Ability to interact externally and internally to support global scientific and business strategy.
•Must possess excellent oral and written English communication skills.
- Strong track record of collaboration 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
- 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 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 short-term incentive programs.
- 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 and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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