Location: Madison, NJ or Irvine, CA
Bill : $176.22-171.99 HR
The Director, Clinical Development will have global or regional responsibilities and fulfil the roles of Core Team Lead, Clinical Program Lead, Clinical Science Lead and Clinical Scientist.
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.
A strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.
First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
As the Core Team Lead, be responsible and accountable for the leadership and results of a project's cross functional Core Team. This entails leading the team throughout the development process as outlined in the Growth Product Flow model, including Life-cycle management.
The Core Team Lead 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.
You will lead the development of the Global Development Strategy, in collaboration with the Core Team and other applicable functional and regional input.
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.
As the Clinical Project Lead, 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 Science Lead and members of the Clinical Sub-Team and ensuring alignment with the agreed Global Development Strategy.
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
Working on one or multiple anti-infective clinical programs
Working in a highly matrixed environment and with various cross functional groups to include study operations, clinical pharmacology, microbiology labs, data programmers, statisticians.
As the Clinical Science Lead , be 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.
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).
Partnering and collaborating with vendors, CRO's, and KOL's .
As the Clinical Scientist , be responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The position supports the Clinical Project Lead and Clinical Science Lead 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 position 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. Writing of clinical study reports and specifically the clinical portions of regulatory submissions
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.
Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Anti Infectives) 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
In this role, we're looking for a leader who will
Act as an Owner
Be Excellence FocusAct as an Influencer
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