Director, Platform Lead, Clinical Data Management (Ivac)

Open for hire at one of the following locations

• Cambridge Erie Street.

• Job ID: 7055

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Director, Platform Lead, Clinical Data Management (iVAC)

Responsibilities

As Director, Platform Lead, Clinical Data Management, you will be responsible for the effective leadership, strategic planning, and oversight at the platform level within the Global Clinical Data Management function. In this role you will ensure the execution and alignment of the data management strategy at the platform level to meet evolving business needs. You must have sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. This position requires working cross-functionally with other key stakeholders and leading DM activities to support regulatory submissions and inspections. You must have experience s as a people manager.

• Supports Director/Senior Director of Clinical Data Management to manage portfolio level DM strategies and execution.

• Liaises with various internal and external groups (Clinical Development, Clinical Operations, Statistics, Statistical Programming, Pharmacovigilance, and external vendors including CROs) for the implementation of data management activities needed for clinical studies within his/her platform.

• May represent Data Management in governance bodies externally with CRO partners and stakeholders, and internally in Core teams.

• Serves as the Data Management Subject Matter Expert representing R&D during regulatory inspections and submissions, and internal audits pertaining to R&D activities within his/her platform.

• Contributes to departmental SOP and process development and improvement, and integration of technology; Support GCP inspection readiness.

• Facilitates internal information sharing to promote learning and best practices.

• Identifies major themes and escalates unresolved data or compliance issues to the functional manager(s).

• Hires, develops, and retains talents. Responsible for the performance management of the Data Management function at platform level, including performance of outsourced data management activities. Line manager of CDM staff, accountable for the recruitment, development and succession planning of staff.

• Provides highest level of CRO/vendor oversight to ensure project plans are executed with high quality.

• Contribute to the efforts to implement and develop Data Management processes and tools based on emerging trends, technology, and best practices.

• Champions Data Management and related expertise to promote best practices across the Drug Development lifecycle.

• Updates skills continually with respect to evolving industry standards, best practices, and therapeutic area knowledge.

• Provides input to and help develop short-term and long-term strategies to improve vendor oversight practices

• Provides input on vendor and technology evaluation, selection, and utilization that aligns with scopes of work

• Oversees and manages the platform clinical data management activities and ensures consistency across the different trials within his/her program; ensures the development and readiness of personnel to deliver on existing programs

• Maintains continued engagement at the core team and platform level to assess needs and build/maintain a capability for data management and analytics

• Support the professional development of direct reports

• Supports significant levels of business change, within own organization and across the broader organization, e.g. standardization

• Strong leadership skills with a passion for people development and an ability to prioritize and provide clear direction to team members in a highly dynamic environment

• Strong interpersonal skills and proven ability to effectively partner with other cross functional departments, includes Clinical Operations and Biometrics to create a best in-class organization

• Focused and versatile team player who is comfortable under pressure, ambiguity, frequent change, or unpredictability

• Proactive and detail-oriented mindset with the ability to ramp up and problem solve across different projects

• Familiarity with Microsoft Office

• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …)

Qualifications

Professional training/ academic degree:

Natural / life sciences, scientific, or bioinformatics / computer science background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position.

Professional experience: Minimum qualification with period (e.g. 3 years in regulated environment).

• A minimum of 12-15 years' experience in a pharmaceutical industry or other clinical research setting with clinical trials; at least 10 years working with clinical data and clinical development processes

• Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timely and quality regulatory submissions

• Highly competent in clinical data management, various EDC systems, CDASH/CDISC standards and medical coding dictionaries.

• 3 years of supervisory experience required; preferred experience with global teams located in several offices

• Experience with function/departmental resource allocation and labor requirement assessment.

• Must have relevant technical skills, CRO oversight, QA/QC, and submission preparation experiences within the pharmaceutical/biotechnology industry.

• Specific cross-study level management expertise is a plus

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations

• Cambridge Erie Street. Apply now for your preferred job and location through our careers site.

• BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!