Dir, Clinical Development

Dir, Clinical Development
  • $110 - $122 per Hour
    HOUR
  • Temporary
  • Madison NJ, US Madison Morris US 07940
Job Ref: JO000105419
Sector: Science
Date Added: 15 September 2020

Dir, Clinical Development

As defined in the scope of the assigned development project(s), the Director, Clinical Development may
have global or regional responsibilities and fulfil the following roles:
• Core Team Lead (CTL)
• Clinical Program Lead (CPL)
• Clinical Science Lead (CSL)
• Clinical Scientist (CS)
The 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 Allergan policies and procedures.
Note: While this job description is intended to be an accurate reflection of the job requirements,
management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.
Key Duties / Responsibilities
Role Core Team Lead (CTL) Oversight:
The CTL is responsible and accountable for the leadership and results of a project’s crossfunctional
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).
Role: Clinical Program Lead (CPL) Oversight:
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.
Role: Clinical Science Lead (CSL) Oversight:
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. 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).
Role: Clinical Scientist (CS) Oversight:
The CS is responsible and accountable for the scientific/clinical implementation of the
Clinical Development Plan at the Clinical Trial Team level. The CS supports the CPL and
CSL 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 CS 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
• Providing a clinical review of study-specific documentation and training materials
• 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
The CS may present the clinical development aspects of a project and clinical trial results
at internal or external meetings (e.g., with Regulatory Authorities, meetings with
external experts).
Minimum Requirements
• Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred
• Minimum 10 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 30% of time, including international travel

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
15/10/2020 12:00:00
USD 110.00 110.00
Contact Consultant:
Jennifer Law

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