Senior Managager - Immunotherapeutics BU (Late Oncology Clinical Development) GlaxoSmithKline Biologicals - Rixensart,Brussels

Job Description

The Immunotherapeutics BU:

Cancer remains a major cause of death and there remains a need for highly efficient and safer therapies. Therefore, GSK Biologicals is developing a novel approach to treat cancer based on Antigen-Specific Cancer Immunotherapeutic(s). ASCIs aim at educating the patients’ own immune system to fight the tumor. This process, which is common for pathogens such as viruses and bacteria, is intended to be harmless for the organism and therefore should elicit very few side-effects when compared to the other common anti-tumor treatments. ASCIs are investigational compounds.
The same Immunotherapy approach is also valid for the treatment of other disease like Alzheimer or Smoking Addiction, and this is also part of the program pursued by GSK Biologicals.

JOB PURPOSE/KEY RESPONSIBILITIES:Currently looking for high-potential candidates to join our ASCI (Antigen-Specific Cancer Immunotherapeutics) Team.
The candidate will lead the Clinical Development activities for a program or product/franchise within the context of the GSK Biologicals’ process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK Biologicals standard operating procedures (SOP).

1. Lead the Clinical Development Activities for a ONE OR MORE PROGRAM / FRANCHISE

Responsibilities include the following activities that are related to a large program or Franchise:

- Responsible for the oversight, development and execution of studies linked to a worldwide clinical development plan. Responsible for integrating global considerations into strategic and operational decisions.
- Leads the matrix team covering all clinical study activities (protocol, data cleaning, statistics, monitors, investigators, regulatory…) and also participate in pan-matrix team activities to draft regional input into worldwide clinical development plans.
- Completes tasks in support of those activities as necessary, such as leading KOL and investigator recruitment processes, developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience at a senior level.
- Drives the integration of relevant regional clinical strategies and propose strategic decisions to GSK Bio Governing Bodies (CLIRA, VSMB,…)
Responsible for the clinical portion of file submission and its registration process.
- Comprehends the strategic needs of Biologicals and wider strategies for registering and marketing vaccines world-wide.
- Accountable for writing clinical expert reports, signing off regulatory documents as clinical expert, negotiating content of clinical regulatory documents with external experts.
- Coaches and develops senior and junior Clinical Development Managers that may be assigned to the project.

2. Is the scientific and management reference for the therapeutic area / franchise (internally/externally)

- Represents GCRD on global/regional Project teams. Liaises internally with Regulatory, R&D, manufacturing, QA&QC, etc and externally with KOL and regulatory authorities worldwide, to ensure proper delivery of the project (s).
- Delivers comprehensive study status reports and communicates them accurately and succinctly as requested.
- Supports internal process improvement activities and initiatives involving coordination of multidisciplinary working team across departments (clinical, safety, regulatory) and maintains contacts with internal and external stakeholders
- Accountable for the medical/legal and human safety aspects of the clinical program.

3. Publishes clinical data in peer review journals and presents in external scientific meetings / congresses. Budget, resourcing and timing- Accountable for consistently achieving high standards in attainment of project timelines in global programs.
- Oversees preparation of investigator agreements and participates in key budget/forecast activities in collaboration with Clinical Project Manager (CPM)..
- Interfaces with the Clinical Project Manager to ensure milestones realization and resource optimization

4. Leads the Clinical Project Team(s)

- Leads at least 1 Clinical Project team (matrix teams including CDM’s, Science Writers, Biostats, Clin Study Coordinators, Cleaning Coordinators) with a spirit of creativity and instills optimism and a can-do attitude. Delegate to CDM reporting to him/her the leadership of some CPT’s when appropriate.
- Provides formal feedback, which encourages team member develop their skills. Provides performance feedback on matrix team members to responsible line managers
- Enhances the knowledge level of the entire team by developing project-specific training programs.
- Consistently displays creative and innovative leadership skills while working in a matrix team.
- May delegate leadership of the clinical project team to a Director, clinical development or a Senior Manager, clinical development
- Provide support to Marketing/Business Development throughout product life cycle
- Influence internal and external groups to meet defined program/project targets.
- Represent the company by gathering crucial information externally that can influence the project and by defending the company position.
- Actively follows-up the product-related Environment
- Responsible for follow-up of project related literature, discussions with KOL and authors, participation in congresses and presenting GSK data.
- Reviews and approves labeling and related promotional materials where applicable.

ACCOUNTABILITY:

Job scope:

The incumbent will manage multiple clinical trials running concurrently, most of which are in early to late Phase III; the total number of subjects enrolled at any time in trials under the incumbent’s supervision can amount up to 50 000; the number of Principal Investigators / sites to manage will typically be in the range of 5-20, but may exceed 50.

Span of accountability:

The incumbent will directly manage at least one matrix clinical project team ( Biostatisticians, Central study coordinators, Scientific Writers and members of Data Management team) and provide advice and consultation to GSK Biologicals for a whole Franchise or a large scope of smaller projects

Desired Skills & Experience

- Candidates MUST Have an MD/Physician’s degree

- Other additional degrees a plus (PhD/ MBA/…)

- Experience in Oncology is a MUST (Lung/ Melanoma/ other therapeutic areas…)

- Over 5 to 10 years expertise in clinical research is a MUST & complete familiarity with international Good Clinical Practice Guidelines, knowledge of human experimentation laws and regulations.

- Sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology, or diseases (oncology, chronic disorders, …)

- Mastery of epidemiological and statistical tools

- Good technical writing and teaching skills; good stage presence for public speaking

- Executive capability to manage people in the future and budget responsibilities

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