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Mgr Sr., Clinical Development

Job Summary

As defined in the scope of the assigned development project(s), the Senior Manager, Clinical Development may have global or regional responsibilities and fulfill the following roles:

Clinical Program Lead (CPL)
Clinical Science Lead (CSL)
Clinical Scientist (CS)

The Senior Manager, 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 of the client's policies and procedures.

Job Responsibilities

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 crossfunctionally 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).

Education & Qualifications

Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred
Minimum 5 years of overall work experience or equivalent combination of experience and education
Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred
Ability to travel up to at least 30% of time, including international travel

Benefits

Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance

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