Associate Director, Clinical Development

Associate Director, Clinical Development
  • $80 - $90 per Hour
    HOUR
  • Temporary
  • Madison NJ, US Madison Morris US 07940
Job Ref: JO000105425
Sector: Science
Date Added: 15 September 2020


Associate Director, Clinical Development

The Associate 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.
Key Duties / Responsibilities Role Core Team Lead (CTL) Oversight:
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).

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 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).

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 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 30% of time, including international travel

Essential Skills & Abilities
The below listed skill sets are core competencies for all Clinical Development positions and the
expectations for each are proportional to both the level of position and project roles that have been assigned

Teamwork
• Understands & leverages cross-functional roles & responsibilities to effectively & efficiently accomplish team goals
• Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
• Participates in team activities
• Actively listens
• Understands and leverages cross-functional roles and responsibilities
• Ability to adapt to change in project and team strategy

Influential Communication
• Uses facts and data to validate own position
• Influences through reason
• Actively seeks to understand other perspectives
• Articulates business impact
• Matches communication to audience
• Ability to build consensus
• Communicates effectively with internal/external stakeholders
• Encourages ideas from others
• Ability to explain complex issues
• Actively influences others without a direct reporting relationship

Strategic Thinking
• Ability to make connections between organization, team, product, ideas, etc.
• Ability to understand implications of strategic decisions
• Seeks more knowledge of industry, competitors
• Welcomes change
• Encourages innovation and efficiency

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 80.00 80.00
Contact Consultant:
Jennifer Law

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