AbbVie

Medical Director, Eye Care

Employer
AbbVie
Location
Irvine, California
Posted
Mar 10, 2021
Ref
2101771
Required Education
Bachelors 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.

Purpose

Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

  • Manages the design and implementation of one or more clinical development programs in support of an 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. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.

  • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.

  • Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.

  • Responsible, with limited supervision, for the proactive monitoring of clinical trial safety which is conducted in collaboration with the ABV CTPS (Clinical Trial Patient Safety).  Evaluates all safety data generated in clinical trials and responds to safety questions from investigator sites and IRBs regarding safety issues and queries.

  • May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.

  • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in 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.

  • May serve on or chair a Clinical Strategy Team (CST), 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 an Asset Development Team (ADT), ADT Leadership Board (ALB) and/or other cross-functional teams and internal stakeholders.

  • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; 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.


Qualifications

Qualifications

  • M.D. or equivalent (D.O.) 

  • 1-5 years of experience in medical safety monitoring of clinical trials is required or having relevant clinical development/pharma experience would be considered.

  • Previous experience in eye care is preferred

  • Track record of successful management of product safety matters (labeling negotiation, etc) preferred

  • Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information highly desirable

  • Advanced analytical skills

  • Basic leadership and decision-making skills

  • Advanced communication skills

  • Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials

  • Basic clinical and/or drug development expertise

  • Good organizational and prioritization skills

  • Intermediate skill in strategic thinking and planning activities

  • Basic negotiation skills and capabilities to influence

  • Good interpersonal skills (i.e. team player)

  • Intermediate computer skills (MS Office); knowledge of ARGUS and Business Objects is a plus

  • Working knowledge of MedDRA

  • Basic statistics and Pharmacoepidemiology

  • Ability to work with limited supervision

  • Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds

  • Flexibility and ability to adapt and learn quickly

  • Ability to work under pressure and to tight deadlines

  • Must possess excellent oral and written English communication skills

  • Willing to travel 20%


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.