Celgene Director, Program Lead - Clinical Research Scientist in Summit, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope:

This position serves a key role to assist the Therapeutic Area Lead CRS in effectively implementing the Global Clinical Development Strategy of the assigned program. This includes line management of an assigned CRS team, serving as key functional advisor and representative for the CRS group, and supporting the Therapeutic Area in the implementation of the clinical development plan for the assigned program. This position ensures program consistency with departmental goals and provides oversight of all clinical studies within assigned program. This position works closely with functions outside of the clinical function and with the global project team to ensure delivery of project timelines with high quality.

Responsibilities will include, but are not limited to, the following:

• Responsible for achievement of project /franchise /corporate goals related to assigned Program

• 1st Line Manager of CRS team assigned to Program

• In collaboration with TA CRS Lead, assigns CRS work & priorities for Program

• Manages team to ensure quality and timeliness of all studies conducted within assigned program; direct and indirect support of all studies in assigned program; ensures alignment within program

• Subject matter expert for TA

• Represent program at global project team meetings

• Preparation for and attendance at governance meetings as required

• Represent CRS function in cross functional activities

• Supports development of Clinical Development Plans; oversees protocol development for clinical studies within the assigned program

• Implement quality assurance plan to ensure high quality deliverables

• Provide training to colleagues and junior members of team

• Supports TA Clinical Science Lead in Sr. Management updates, resource and budget activities

• Leads high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, Regulatory Authority)

• May serve as a Clinical Document Template owner (protocol, ICF, etc)

• Ensure TMFs are properly maintained

• Clinical timeline management / project management interface

• Lead Program clinical review and interpretation of data

• Direct support of abstracts/publications

• Safety updates (PSUR/DSUR, Orphan Drug, etc)

• Clinical authorship and review of key documents (i.e. protocol concept sheet, protocol, ICF, IB, SPA, BB, CSR)

• Continuous improvement of study specific processes and/or plans

• Presents data and information to external investigators

• Identify and liaise with internal and external collaborators independently

• Act independently to identify and resolve program level current/active issues; escalates to TA Lead CRS as appropriate

• Collaborates with other functions and/or Principal II to manage escalated issues

• Proactive risk identification and mitigation at program level

• May support process improvement and functional trainings at departmental level

*LI-AG1

Qualifications

Skills/Knowledge Required:

• Degree in Life Sciences with extensive experience in clinical research or equivalent

• Demonstrated proficiency in CRD work

• Advanced degree preferred

• Proficiency in managing direct or indirect employees or leading teams

• At least 8 years of experience in CR&D roles/responsibilities

• Advanced knowledge of GCP/ICH, overall drug development process from discovery to registration, study design, statistics, clinical operations

• Experience in driving, managing and collaborating in a team/matrix work environment

• Advanced ability to analyze, interpret, and present data

• Advanced knowledge of indication, therapeutic area, competitive landscape and health authority requirements

• Advanced medical writing and presentation skills

• Ability to self-supervise

• Ability to act independently to identify and resolve program level issues

• Recognized internally and externally as a TA and Functional expert

• Effective planning and time management

• Strong verbal, written and interpersonal skills (communication skills)

• Drives for high quality results

• Adaptable and analytical

• Strong presentation skills / leadership presence

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Director, Program Lead - Clinical Research Scientist

Location: Summit, NJ, US

Job ID: 17001111