Allergan Sr Mgr, Clinical Development in Irvine, California

Sr Mgr, Clinical Development

Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/6196/other-jobs-matching/location-only

Aug 03, 2018Post Date

182041Requisition #

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 pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.

Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world’s fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description

The Senior Manager, Clinical Development – Ophthalmology 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 – Ophthalmology 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.

Main Areas ofResponsibilities

Clinical Program Lead (CPL)

  • Ensuring alignment between the Core Team, ClinicalSub‐teamand Clinical Trial Team(s)

  • Developing the proposed clinical milestones with theClinical Sub‐team

  • Working towards the achievement of defined projectstage gates and milestones

  • Overseeing all clinical development activities incollaboration with the Clinical Sub‐Team and Clinical TrialTeam(s)

  • Managing the project‐related clinical development budget withthe Clinical Sub‐Team and Project Manager

  • Ensuring that decisions made by the ClinicalSub‐teamhave functional backing

  • Communicating project progress to their linefunction managers

  • Communicating to the Core Team leader, Core Team andrelevant functions any potential issues or risks (e.g., changes or significantrisks to the Clinical Development Plan, new safety concerns) upon identificationin a timely manner

  • Providing Clinical Development oversight on clinicaldevelopment aspects for ongoing clinical trials

Clinical Science Lead (CSL)

  • Acting as a key contact for the Core Team, ClinicalSub‐teamand Clinical Trial Team(s) regarding the scientific/clinical development aspectsof a project

  • Providing scientific/clinical oversight for theclinical trial in collaboration with the Clinical Sub‐teammembers

  • Ensuring the review of clinical data, includingprotocol deviations

  • Interpreting and communicating, with the CPL,clinical trial results

  • Collaborating with the CPL, the ClinicalSub‐teamand functional representatives in the development of clinical trial, regulatoryand other scientific documents (e.g., Regulatory documents, presentations atcongresses and publications)

Clinical Scientist (CS)

  • Representing Clinical Development as a core teammember on the Clinical Trial Team

  • Providing a clinical review of study‐specificdocumentation and training materials

  • Performing clinical data reviews

  • Assessing reported protocol deviations

  • Ensuring resolution of identified issues duringclinical data and protocol deviation

  • reviews cross‐functionally and with Investigationalsites in collaboration with the Clinical Trial Team

Requirements

  • Minimum 5 years of overall work experience orequivalent combination of experience and education

  • Minimum 3 years of clinical/research experience inthe pharmaceutical/device industry preferred

  • Ability to travel up to at least 30% of time,including international travel

Education

  • Relevant science degree (e.g., MD, PharmD,PhD)

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.