Scientific Director, Translational Medicine Specialist
5 days ago
Absorbent AbbVie is seeking a talented individual to spearhead the planning and execution of the safety strategy for Immunology assets or potential assets in early development.
Key Responsibilities:- Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and early clinical safety findings to facilitate benefit-risk decision making and risk mitigation in clinical development through phase 2a for AbbVie GI, dermatology and rheumatology development programs.
- Reviews and/or summarizes scientific data for key safety documents (such as the Investigator's Brochure or Development Safety Update Report) for early development assets to ensure they contain high quality medical safety content and are clearly written.
- Facilitate scientific connections and interactions, info exchange across assets within the safety teams
- Prepare material on competitive intelligence, current disease state and standard of care for key indications/ disease states
- Supports PPS in assigned due diligence activities for immunology.
- Compiles draft slide presentations for internal and external safety meetings as directed by Executive Director, Translational Medicine, Immunology
- Interacts with and influences other cross functional departments (e.g. Toxicology, Pharmacokinetics, Business Development, Clinical and Regulatory Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessment to support study participants in early development programs.
- Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)
- 5+ years of experience in Pharmacovigilance / Clinical Development / Development biological Sciences experience in the pharmaceutical industry.
- Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer reviewed publication record.
- Experience participating in due diligence exercises to inform go/no-go decisions is strongly preferred.
- 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
- Ability to exercise judgment and address complex problems and create solutions across multiple projects
- Must be able to lead and manage through influence.
- Effectively provide input on technical safety documents
- Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment
- Must possess excellent oral and written English communication skills.
- Ability to work effectively under circumstances of uncertainty and complexity.
The estimated annual salary range for this role is between $120,000 - $180,000 per year, based on factors such as location and level of experience. Additionally, eligible employees will receive a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k).
About AbbVieAbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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.
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