Associate Director, Clinical Development

Job Description

The Associate Director, Clinical Development will have global or regional responsibilities. Lead the design, development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Provides medical and/or scientific direction to project/study teams. Should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.

The position will be based in Irvine, CA with a hybrid schedule of 3 days in office. 

Responsibilities:

The Associate Director will be responsible and accountable for the development, implementation, and delivery of the global clinical development strategy for a given project within time, budget and with high quality.  This will entail leading the development of the Clinical Development Plan in collaboration with the Clinical Team and ensuring alignment with the agreed Global Development Strategy/ Integrated Evidence Plan.  

Responsibilities include the following:

• Assists in the design of clinical studies. Responsibilities may extend from early translational development activities to mature product life cycle strategies.
• In conjunction with Clinical Leader, designs, conducts, reports clinical trials in line with the development, regulatory and commercial strategy.
• May be responsible for opinion leader development within the therapeutic area Interacts with and coordinates appropriate scientific activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going clinical studies or projects.
• Assists as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
• Assists in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences or medical literature and acts as a therapeutic area resource.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, partner discussions, etc. 
• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements
• May lead cross functional sub-teams responsible for defined sub-projects within the therapeutic area (individual publications or study collaborations).
• May initiate research projects compatible with project plan goals and drive them to completion, resulting in high quality publications
• 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, in collaboration with clinical operations, 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 Integrated Evidence Strategy 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, clinical trial results.
• Collaborating with the clinical leaders, and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications).
   

Qualifications

• Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Toxins) preferred.
• Minimum 7 years of overall work experience or equivalent combination of experience and education.
• Minimum 5 years of clinical/research experience in the pharmaceutical/device industry preferred.
• Ability to travel up to 15% of time, including international travel.
   

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company