Manager, Clinical Development

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.

The Manager, Clinical Development will have global or regional responsibilities and fulfil the roles of Clinical Science Lead and Clinical Scientist. The Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as provide guidance to other team members. 

Key Responsibilities

As the Clinical Science Lead, be responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications associated with the clinical trials. You will participate in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, the CSL is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan and is responsible for:

• Acting as a key contact for the Core Team, Clinical Sub-team and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project.
• Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members.
• Ensuring the review of clinical data, including protocol deviations.
• Interpreting and communicating, with the Clinical Program Lead (CPL), clinical trial results.
• Collaborating with the CPL, the Clinical Sub-team and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications).   

As the Clinical Scientist, be responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The position supports the Clinical Project Lead and Clinical Science Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The position is the key Clinical Development contact for the Clinical Trial Team and is responsible for:

• Representing Clinical Development as a core team member on the Clinical Trial Team
• Working towards the achievement of defined project milestones
• Providing a clinical review of study-specific documentation and training materials. Writing of clinical study reports and specifically the clinical portions of regulatory submissions
• Performing clinical data reviews
• Assessing reported protocol deviations
• Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team.
   

Qualifications

Qualifications: 

• Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Aesthetics) preferred.
• Minimum 5 years of overall work experience or equivalent combination of experience and education.
• Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred.
• Ability to travel up to at least 30% of time, including international travel

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
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.