Director/Senior Director (CART Registry), Medical Affairs Operations

Req #: 1802394
Location:Boudry, NeuchatelCH
Job Category:Medical
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene R&D Sarl
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

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.

POSITION

Director/Senior Director (CART Registry), Medical Affairs Operations

SUPERVISOR

Executive Director, Medical Affairs Communications and Operations (MACO), Celgene Worldwide Markets

DEPARTMENT

Medical Affairs, Celgene Worldwide Markets

PREREQUISITES

Graduate qualification (preferably PhD) in medical or science area or equivalent work experience. Minimum 8 years relevant business experience required (preferably in the biotech or pharmaceutical industry), including experience of managing clinical trials and observational research

The Director CAR T registry will oversee the preparation, implementation, of maintenance CAR T Registries for post-marketing observational of the commercial use of CAR T constructs in line with Celgene strategy. The role will be responsible for the CAR T registry programme globally (i.e. within Worldwide Markets and the US).

The role will need to work in close collaboration with a cross functional team to develop, implement and oversee the Celgene strategy for CAR Ts, and to ensure post marketing regulatory commitments are achieved, as well as internal data needs are fulfilled. The role will also work in close partnership with

CAR T medical leadership globally and within the regions.

The role will also work in close collaboration with external partners based on Celgene strategic needs.

This role may also include registry development for other products or constructs as needed based on

future development plans.

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

• Create in conjunction with cross functional team the strategyand project timelines for post marking data generation in line with regulatory guidance, Celgene strategy, reimbursement data needs, and legal guidance


• Implementpost marketing registry to capture required data for CAR T globally (all markets). The operational model will be in line with regulatory guidance and Celgene strategy and will need to be conducted in partnership with external academic partners, KOLs, and other stakeholders as needed


• To define in a cross functional team, the data reporting needs for Celgene internal, reimbursement, and regulatory activities and commitments. To implement the report requirements in the CAR T registry as it is developed


• To provide strong leadership internally and externally with clear communication and stakeholder engagement to ensure all milestones are developed, communicated and achieved per regulatory and other timelines


• To provide operational expertise and leadership to ensure correct functions are involved and give input into all aspects of the registry development, including but not limited to: safety reporting requirements, sponsorship model, IP and Data protection considerations, data validation and quality standards, analysis planning, HEOR/HTA data variables, regulatory requirements.


• To develop a communication plan for the ongoing activities of the registry including, in conjunction with relevant functions, publication plans.


• Development of relevant SOPs and processes (as needed) to ensure inspection ready oversight of operating model


• To develop and implement a long term operational model to ensure the 15-year commitment for CAR T registry data is integrated into current business and operational structures.


• Advanced Therapy Medicinal Products (ATMPs) related activities


• Provide clinical trial/registry expertise into Celgene broader activities related to CAR T and other ATMPs as needed. This includes, but is not limited to regulatory strategy, external projects on ATMPs, and related projects on the capture and use of real world evidence.

Skills/Knowledge Required:

• Experience in managing interventional and observational studies with good understanding of GCP and ICH guidelines and PV & other legislation affecting post marketing study activities. EMA region experience required, US and experience in other regions an advantage.


• Good understanding of financial systems, budget management, and good understanding of contacting process and management of external 3rd party contracting and relationships


• Experience in matrix management of cross functional teams and across different geographies and timezones.


• Excellent communication and interpersonal skills with ability to communicate and coordinate within a team and across multiple disciplines and countries.


• Good organizational and project management skills


• Proactive with an ability to multitask and prioritise


• Strong identification with Celgene’s values

Desirable

• Knowledge of and experience in oncology/haematology


• Experience in line management


• Experience in Medical Affairs partnership with external academic research groups on company or independent research projects

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