Associate Director Clinical Development
Associate Director Clinical Development
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Salary Not Disclosed
1 Vacancy
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 may be based in Branchburg NJ or Irvine CA.
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 ongoing 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 subteams responsible for defined subprojects 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 Subteam members.
- Ensuring the review of clinical data including protocol deviations.
- Interpreting and communicating with the CPL 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 at least 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:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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 status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
