AbbVie

Assistant/Associate Scientific Director

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Jan 22, 2021
Ref
2100887
Required Education
Associate Degree
Position Type
Full time

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Associate/Assistant Scientific Director, Medical Affairs

Job Description
The Associate/Assistant Director, Medical Affairs has a key role within the BOTOX Therapeutic & Migraine Therapeutic Area. Working under the leadership of the Scientific Director/Medical Director, this leader supports the development and execution of the migraine medical strategy, specifically as it pertains to onabotulinumtoxinA (BOTOX) in Migraine by providing scientific, strategic and operational input into core medical affairs activities including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation, this leader ensures tactical execution is relevant to the market- physicians, patients and payors.
The Associate/Assistant Director, Medical Affairs must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable US regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
The employee is expected to be fully capable of performing roles encompassed in the preceding grade levels within the job family as required by the organization. Additional activities, special projects and assignments may be given, as required. As a result, the percentage of time spent across key duties and responsibilities will vary depending on project assignments, therapeutic area needs and the requirements within the Therapeutic Area.

Key Responsibilities
• With oversight, contributes to the development of medical migraine strategy for BOTOX in Migraine.
• Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with atogepant strategic plan.
• Leads the US Conference planning and execution.
• May be responsible for Medical Review (MR) training for on label, clinical data and disease state for atogepant.
• Responsible for managing budget for assigned projects including consulting and vendor management.
• Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication
• Provides subject matter expertise for MSL, health outcomes and commercial teams including competitive assessments and regular scientific literature reviews.
• Aligns medical education and scientific initiatives with atogepant Scientific Communication Platform
• Contributes to the strategic and leads annual medical tactical planning initiatives.
• Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
• Contributes to all launch readiness reviews/planning.

Qualifications

Education and Experience
• Medical degree, PhD, PharmD and/or other higher scientific degree. Preferably 'board certified specialty qualification' or equivalent and pharmaceutical industry recognized qualification e.g. MSc
• At least 3-5 years of biopharmaceutical/medical device industry experience, including substantial understanding of relevant therapeutic area required.

Essential Skills and Abilities
• Should have a good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Good understanding of Medical Affairs principles, study design and publications.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
• Ability to interact externally and internally to support global business strategy.
• Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills. (both oral and written)
• Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
• Proficient with electronic systems including Microsoft Office Suite, SharePoint, videoconferencing platforms
• Ability to handle and prioritize multiple priorities
• Self-starter with ability to work independently with remote or minimal supervision
• Ability to work effectively in a team/matrix environment
• Ability to influence others without direct reporting relationships
• Works with some supervision and guidance. Exercises judgment within well-defined practices and policies.

Equal Opportunity Employer Minorities/Women/Veterans/Disable

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.