Medical Director, Glaucoma
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.
The Director, Medical Affairs, Glaucoma is a key strategic leader within GPRD - GMA USMA. Working
under the leadership of the Glaucoma Sr. Medical/Scientific Director, this role develops a comprehensive medical strategy for each of the products within their respective area of responsibility, with a focus on evidence generation. They work closely with colleagues in Global Medical Affairs, HEOR, Patient Safety & Epidemiology and the Integrated Evidence Strategy Teams, as well
as colleagues within the broader R&D and Commercial organizations. Key deliverables include the development of the Medical Affairs strategy and tactics for the respective therapeutic area that includes data generation, scientific communications and synthesis of insights. This leader will provide medical practice insights to support the clinical development, HEOR, publications, marketing, sales, and regulatory functions to ensure that they are developing product and development strategies that will be relevant to the market - patients, payors and physicians. The Director, Medical Affairs must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regional regulatory requirements. Allergan 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 GMA SP.
KEY DUTIES AND RESPONSIBILITIES:
- Strategic and Tactical Planning
• Manage the development and implementation of the USMA evidence plan and contribute to the Global Medical Affairs strategic and tactical plans.
o Measure and communicate team performance and progress on project milestones
o Ensure alignment of broader GMA functional activities to the TA Medical Affairs strategic plans
o Provide input in the Medical Science Liaison (MSL) plans leveraging emerging data and insights from the SOC.Develop educational parameters for independent and Allergan-led medical education (if applicable)
o Support GMA staff within the US Affiliate to facilitate implementation of strategies and tactics
• Serve as the USMA Lead for assigned Core teams involving products within the TA
o Ensure implementation of the assigned rommercial sub-teams
o Represent USMA on Clinical sub-teams (incl the IEST)
• Contribute to Commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment.
o Advise and support Commercial colleagues in the development of their marketing plans and materials
2. Medical and Scientific Data Generation and Communication
• Lead the development and execution of the US Glaucoma data generation plans (e.g. Phase 4 and IIT) to provide post marketing data that support our products and the patients and HCPs that use them.
• Collaborate with the External Scientific Communications team to contribute to robust publication plans that are aligned with GMA data generation.
• Contribute to the development and review of GMA trial proposals and publications.
• Be responsible for MSL materials and content used in communications of our research interests
• Establish and maintain internal organizational links with the broader R&D, Commercial and other Allergan departments to ensure appropriate support for Allergan projects.
3. External Relationships
• Establish and maintain relationships with top tier thought leaders in the respective therapeutic area to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure thought leader development and communication is optimized, and that evidence generation opportunities are identified. Collaborate with HEOR to generate evidence that establishes scientific and clinical credibility with payers, managed market/market access and healthcare decision makers.
• Assess external IIT proposals and concepts related to the therapeutic area to ensure alignment with strategy
• Deliver portfolio-related clinical presentations and participate in prioritized scientific congresses.
Education and Experience
- Medical Doctorate (M.D.) degree or Doctor of Optometry (O.D.) degree or equivalent (D.O. or non-US equivalent of M.D meet requirements) with relevant therapeutic specialty experience in an academic or clinical practice environment.
- Typically 10-12 years’ experience in the pharmaceutical industry or equivalent preferred; substantial understanding of relevant therapeutic area required.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
- May have performed protocol design in the academic environment and/or acted as an assistant PI.
Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
Essential Skills and Abilities
• Must have a solid 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 lawsand other applicable local regulations
• Good understanding of Medical Affairs principles, study design and publications.
• 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
• Demonstrated strengths in the following areas:
o Planning, organizational, project management and analytical skills
o Oral and written communication
o Time management
o Conflict management and resolution
o Problem solving
o Attention to detail
o Interpersonal and networking skills
o Motivational skills
o Cross-cultural sensitivity
o Customer service orientation
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.