Director Clinical Development

Director Clinical Development
Company:

Software Guidance & Assistance


Director Clinical Development

Details of the offer

Location: Madison, NJ or Irvine, CA
Bill : $176.22-171.99 HR

Responsibilities

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.

You Will

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.

Qualifications
:

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

Requirements


Knowledges:

  • PROGRESS

Rn

Overview: CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U...


From Commonspirit - St. Vincent Infirmary Med Ctr - Arkansas

Published a month ago

Multi

MULTI-SPECIALTY CODER/AUDITOR I Part-Time/Full-Time | Remote With oversight from the department manager and exercising independent judgment within the scope of...


From Managed Resources, Inc (Mri) - California

Published a month ago

Ims engineering common process lead

Description:The IMS segment Engineering Operations team requires an engineer to lead the development and maintenance of common engineering process...


From L3Harris Technologies - Florida

Published a month ago

Assistant manager of quality

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders...


From Csl Plasma - New Jersey

Published a month ago