- Interpreting regulations related to pharmacovigilance and clinical trial development supporting all patient safety activities.
- In depth understanding and application of the pharmacology, chemistry, non-clinical toxicology, pharmacokinetics and statistics to effectively conduct and provide oversight to safety surveillance and signal detection activities and innovative early phase clinical trials design, dose selection and safety monitoring
- Responsible/oversight of safety surveillance for pharmaceutical / biological / drug –device combined products in early oncology pipeline
- Lead and oversee the safety physicians in setting the strategy for key pharmacovigilance and clinical documents, including but not limited to, medical safety assessments, regulatory responses, protocols, IB, etc..
- Apply current regulatory guidance as appropriate to guide the team in conducting safety surveillance and signal detection for early oncology products
- Ability to analyze and interpret aggregate safety data (and guiding the safety team to do that as well) and communicate these analysis and interpretation to executive leadership
- Effectively write, review and provide input on technical documents independently and provide guidance and oversight to the safety team in doing so
- Oversight and ultimate responsibility for periodic reports (DSUR’s, 6 months SUSAR LL etc.) and guide the safety physicians in leading the strategy for each document, at each product level
- Ultimately Responsible for overseeing the adequacy of risk mitigation strategies for early oncology products while overseeing the safety physicians developing it
- Proactively engaging, inspiring, coaching and mentoring direct reports, team members and colleagues
- Managing other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
- Assumes responsibility for coordinating and overseeing safety related activities at a product level, especially ADCs, across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program, portfolio of programs, especially ADCs, and for overseeing approval enabling related activities. Possibility to Leading specific Product Safety Teams (PST) and supporting one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Representing the safety organization cross functionally for early oncology products.
- MD / DO with 2+ years of internal medicine residency and direct experience in patient management required
- Clinical pharmacology fellowship or PhD is strongly preferred in addition to MD / DO, not required
- 10+ years of Pharmacovigilance / Clinical Development experience
- Early development experience (first in human/phase 1/1B trials) in pharmacovigilance/Clinical development required
- Oncology experience especially in ADCs molecules is required (3 or more years)
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendations / opinions in group environment, including executive leadership, both internally and externally
- Write, review and provide input on technical documents
- Work collaboratively and lead cross-functional teams
- Ability to lead cross-functional teams in a collaborative environment
- Fluency, both written and oral, in English
- Evaluate and make independent decisions. Ability to work effectively in situations of uncertainty and complexity, ability to multi-task.
Experiences / Leadership traits:
- Ability to work collaboratively with colleagues with different areas of expertise (e.g statistics, regulatory, clinical, toxicology…)
- Ability to make independent decisions
- Ability to influence cross functional stakeholders - internal and across industry, and regulatory authorities
- A clear and solid understanding of PV and clinical development, early development and monitoring clinical trials, post-marketing safety
- Strong understanding of oncology, including remaining up to date with disease and treatment evolving landscape
- Ability to promote an inclusive work environment, encourage diverse ideas, different point of views and collaboration towards the same goals. Ability to influence and inspire teams and colleagues
- Strong executive presence
- Previous experience in managing physicians' direct reports (including senior medical directors) and large teams.
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.