- Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Primary responsibility for and ownership of 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 Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
- Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to 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.
- 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.
- Ability to run a complex clinical research program independently.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Extensive 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.
- Ability to exercise judgment and address complex problems and create solutions for one or more projects.
-
Director of Translational Medicine Oncology Drug
2 weeks ago
AstraZeneca Mississauga, Canada**Director of Translational Medicine Oncology Drug Project Management** · **Location: Gaithersburg, MD and Waltham, MA** · The TM Oncology Drug Project Management group within Translational Medicine Oncology is accountable for providing project and portfolio management to the AZ ...
-
Associate Director, USMAx Pipeline, Oncology
2 weeks ago
Allergan Hamilton, Canada TEMPORARYAbbVie'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, oncolog ...
-
Associate Director, Oncology Outcomes Research
2 weeks ago
AstraZeneca Mississauga, CanadaAt AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help p ...
-
Associate Director, Oncology Data Science
2 days ago
AstraZeneca Mississauga, Canada**Associate Director, Oncology Data Science** · Mississauga, Ontario · **Accountabilities**: · **Essential Skills/Experience**: · - PhD in Data Science, Statistics, Bioinformatics, Computer Science, or a related quantitative field, with more than three years of experience in Phar ...
-
Allergan Hamilton, CanadaNorth Chicago, IL · Function: Research & Development · Area of Interest: Data & Statistical Sciences (DSS) · 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 st ...
-
Allergan Hamilton, CanadaNorth Chicago, IL · Function: Research & Development · Area of Interest: Data & Statistical Sciences (DSS) · 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 ...
-
Program Management Director, Oncology R&d
2 weeks ago
AstraZeneca Mississauga, Canada**Director Program Management, Oncology R&D (ORD)** · **Hybrid Work · - on average 3 days/week from office** · **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** · At AstraZeneca, we pride ourselves on crafting a collaborative culture ...
-
Allergan Hamilton, CanadaSenior Medical Director, Oncology Early Development · 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 acr ...
-
Allergan Hamilton, CanadaSenior Medical Director, Oncology Early Development 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 ...
-
Allergan Hamilton, ON, CanadaCompany 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 area ...
-
Allergan Hamilton, ON, CanadaSenior Medical Director, Oncology Early Development · 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 acr ...
-
Allergan Hamilton, ON, CanadaAssistant (or Associate) Medical Director, Oncology Japan Development · 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 ...
-
Allergan Hamilton, ON, CanadaAssistant (or Associate) Medical Director, Oncology Japan Development · 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 ...
-
Allergan Hamilton, Canada TEMPORARYAssistant (or Associate) Medical Director, Oncology Japan Development 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 peo ...
-
Accounting Specialist
3 weeks ago
Fusion Pharmaceuticals US Inc Hamilton, CanadaFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
-
Document Control Specialist I
2 weeks ago
Fusion Pharmaceuticals US Inc Hamilton, Canada**Fusion Pharmaceuticals (NASDAQ: FUSN)** is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitt ...
-
Production Operator
3 weeks ago
Fusion Pharmaceuticals US Inc Hamilton, Canada**Fusion Pharmaceuticals (NASDAQ: FUSN)** is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitt ...
-
Key Account Manager
3 weeks ago
Bristol Myers Squibb Hamilton, CanadaAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
-
Administrative Assistant
4 days ago
McMaster University Hamilton, Canada**Schedule** · Monday to Friday, 8:30-4:30 · **Education Level** · 2-Year Community College diploma in Office Administration or related field of study · **Career Level** · Requires 4 years of relevant experience · Unit Description · Ranked as one of the world's Top 100 universiti ...
-
Project Director – Commercial Oncology
1 day ago
AstraZeneca Mississauga, Canada Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the importance of ind ...
Medical Director/Senior Medical Director, Oncology - Hamilton, ON, Canada - Allergan
Description
Senior Medical Director, Oncology Early DevelopmentAbbVie'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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.The Senior Medical Director leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.
Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex 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.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.
#
