Allergan Sr Mgr, Clinical Development in Madison, New Jersey

Sr Mgr, Clinical Development

Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/7655/other-jobs-matching/location-only

Jan 08, 2019Post Date

186749Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

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

Main Areas of 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 SubTeam, 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 SubTeam 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.

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 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).

Requirements

· 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

Preferred Skills/Qualification

· Understands 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

· 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

· 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

· Identifies and resolves complex problems in a solution oriented manner

· Delegates to team and keeps them focused, as applicable • Identifies and implements best practices

· Identifies and drives priorities

· Takes charge of removing obstacles to project as appropriate with the team

· Ability to work on and communicate solutions, even in the case of unpopular business needs

· Meets corporate timelines

· Ability to make tough decisions quickly

· Demonstrates basic understanding of global pharmaceutical/ device product development environment

· Builds relationships with global colleagues

· Demonstrates understanding and respect for cultural differences and needs

· Inclusive in interaction with others

· Embraces diversity of thoughts, ideas, and approaches

Education

· 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

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.