AbbVie

Executive Director, Clinical Development

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Feb 09, 2021
Ref
2102203
Required Education
Doctorate/PHD/MD
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 .

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

As defined in the scope of the assigned development project(s), the Executive Director, Clinical Development may have global or regional responsibilities and fulfil the following roles:
  • Therapeutic Area Section Head
  • Core Team Lead (CTL)
  • Clinical Program Lead (CPL)
  • Clinical Science Lead (CSL)

The Executive Director, Clinical Development 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 employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all AbbVie policies and procedures.

YOU ARE more than just a title, YOU ARE...

First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
You Will

Therapeutic Area Section Head

(TA Section Head)

The TA Section Head is responsible and accountable for the oversight and leadership of the Clinical Development staff and Clinical Development programs in the relevant TA Section. Additional TA Section Head responsibilities for the respective TA Section include:
  • Leading and acting as the key point of accountability for the development activities across multiple compounds or indications within the TA Section.
  • Leading, mentoring and overseeing TA Section members.
  • Representing the TA Section at Regulatory agencies or other relevant meetings.
  • Establishing and maintaining a strong network of peers within the Pharmaceutical industry.
  • Representing R&D at scheduled symposia and meetings.
  • Working closely with Business development in the assessment and review/due diligence of in - licensing opportunities.

The TAH may delegate specific tasks and responsibilities to the TA Section Head as applicable to a given TA structure.

Core Team Lead (CTL)

The CTL is responsible and accountable for the leadership and results of a project's cross functional Core Team. The CTL leads the team throughout the development process as outlined in the Growth Product Flow model, including Life - cycle management. The CTL fosters an atmosphere of collaboration, mutual respect, transparent communication, and data driven analyses according to the highest scientific standards and a focus on efficient and timely solutions. He/she leads the development of the Global Development Strategy, in collaboration with the Core Team and other applicable functional and regional input. Once completed, the CTL leads the execution of the agreed Global Development Strategy and is responsible for:
  • Ensuring alignment between the Governance Board, Core Team and Sub - teams.
  • Developing the project milestones with the Core team and seeking endorsement from the Governance Board on the Global Development Strategy, Stage Gates and other decisions requiring Governance Board endorsement.
  • Guiding the project through the defined Stage Gates.
  • Analyzing, managing project risks and proposing solutions for risk mitigation.
  • Resolving project/functional conflicts.
  • Managing, together with the Project Manager, the project budget and timelines.
  • With the Project Manager and core project team members from Commercial, managing the valuation of the project.
  • Communicating any potential risks to the Governance Board co - chairs and any relevant line functions in a timely manner.
  • If applicable, managing external partnerships and ensuring alignment and preparation for Joint Development Committee (JDC) meetings

The CTL may present the project, including clinical development aspects and results, at internal or external meetings (e.g., with Regulatory Authorities, with external experts).

Clinical Program Lead (CPL)

The CPL is 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. He/she leads the development of the Clinical Development Plan in collaboration with the Clinical Science Lead and members of the Clinical Sub - Team, ensuring alignment with the agreed Global Development Strategy. Once completed, the CPL leads the execution of the agreed Clinical Development Plan and is responsible for:
  • Ensuring alignment between the Core Team, Clinical Sub - team and Clinical Trial Team(s).
  • Developing the proposed clinical milestones with the Clinical Sub - team.
  • Working towards the achievement of defined project stage gates and milestones.
  • Overseeing all clinical development activities in collaboration with the Clinical Sub - Team and Clinical Trial Team(s).
  • Managing the project - related clinical development budget with the Clinical Sub - Team and Project Manager.
  • Ensuring that decisions made by the Clinical Sub - team have functional backing.
  • Communicating project progress to their line function managers.
  • Communicating to the Core Team leader, Core Team and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) upon identification in a timely manner.
  • Providing Clinical Development oversight on clinical development aspects for ongoing clinical trials.
  • In this role, the CPL may be the Clinical Sub - Team Chair, and as such a Core Team member.

As the Clinical Sub - Team Chair, the CPL will represent the Clinical Sub - Team at the Core Team and ensures timely escalation to the Core Team (with appropriate functional representation) and the communication of information between the Core Team, Clinical Sub - team, Clinical Trial Team(s), and other functional sub - teams, as needed.

Clinical Science Lead (CSL)

The CSL is 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. In collaboration with the CPL and Clinical Sub - team members, the CSL participates 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 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).
  • The CSL may present the clinical development aspects of a project and clinical trial results at internal or external meetings (e.g., with Regulatory Authorities, with external experts).

#LI-PD1 I-P D1

Qualifications

You Bring
  • Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant herapeutic Area preferred.
  • Minimum 12 years of overall work experience or equivalent combination of experience and education.
  • Minimum 6 years of clinical/research experience in the pharmaceutical/device industry.
  • Ability to travel up to at least 30% of time, including international travel.

In this role, we're looking for a leader who will :

• Act as an Owner

• Be Excellence Focused

• Act as an Influencer

Significant Work Activities
N/A
Travel
Yes, 15 % 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.