Director*, Risk Management Strategy, Global Clinical Development Operations

  • BioNTech Careers
  • Cambridge, Massachusetts
  • Research, development, teaching
  • Published: 18.11.2022
scheme imagescheme imagescheme image

Become a member of the BioNTech Family!

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

Director*, Risk Management Strategy, Global Clinical Development Operations

The Director, Risk Management Strategy, Global Clinical Development Operations (GCDO), is responsible for leading, developing, and implementing of integrated risk management strategy inclusive of considerations for a Risk Based Quality Management (RBQM) framework in Global Clinical Development Operations and support of ongoing cross-functional risk assessment and management across the study lifecycle.   
This is a leadership position within GCDO to direct and expand approaches that focus on remote risk detection leveraging advanced analytics and robust risk management to preserve trial integrity, enhance data quality, and emphasize participant safety. This role will work closely with internal cross-functional stakeholders and external partners to lead RBQM operationalization. This is a highly collaborative and dynamic role within a fast-paced and results-oriented environment. The ideal candidate should be an outstanding team player who can effectively lead, communicate, and influence internal and external stakeholders.  This role will play as a critical integrator with an emphasis on the development and implementation of processes and procedures, collaboration with site-facing partner organizations, and influence and enablement of a right-sized technology infrastructure to support RBQM.

Responsibilities & Qualifications

  • Define the systematic risk management and governance process, including requirements for documentation, analysis, and performance trends across individual functions and multiple projects/programs
  • Develop and champion learnings of the understanding of integrated risk management, risk-based monitoring (RBM), and the larger RBQM framework
  • Develop and implement training across GCDO on RBQM and its elements
  • Serve as business process owner for RBQM procedures (SOPs, guidelines, policies, etc.) within GCDO and drive the development and optimization of standardized tools and guidance documents to support the study teams
  • Maintain the internal risk, metrics, quality tolerance limits (QTLs), and key risk indicators (KRI) libraries utilizing a centralized monitoring approach, on-site vs. remote monitoring, and SDV and SDR requirements
  • Define, implement, and continuously refine the framework for study-level RBQM adoption based on study complexity and risk assessment
  • Collaborate with trial managers and CRO partners to ensure adaptive monitoring processes align with BioNTech RBQM framework
  • Define and implement a holistic approach to drive cross-functional adoption of RBQM methodology, and work closely with key stakeholders to assess and manage the impact on their respective functions
  • Develop standard reports and dashboards for trending analysis of data quality and site performance, focusing on Critical-to-Quality (CtQ) risks
  • Define and document best practices for inspection readiness
  • Support sponsor inspections and regulatory interactions as it relates to BioNTech’s adoption of the RBQM framework
  • Identify and ensure dissemination of RBQM best practices across studies, programs, and functions
  • Act as internal Subject Matter Expert (SME) in RBQM methodology
  • Support study teams with the implementation of RBQM strategies, including study-level risk identification, assessment, and mitigation activities
  • Facilitate study-level risk review meetings with cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecycle
  • In collaboration with trial managers, ensure appropriate oversight and mitigation of CtQ risks, including preparation for inspection readiness
  • Drive long-term strategy and sourcing decisions to support CRO partner approach to RBQM
  • Support identification and implementation of related technologies and tools
  • Collaborate closely with CRO partners to oversee risk through adequate sponsor oversight
  • Thrives in ambiguity and can look at RBQM processes from an overarching viewpoint to see what can be optimized; prepared to drive that optimization
  • Drives continual improvement initiatives with external partners
  • Responsible for influencing and aligning Executives and Senior Leaders on the adoption of RBQM practices and processes within their teams and being a change sponsor within their teams to implement the necessary changes
  • Recommend technology investments to Executives in support of enabling RBQM solutions
  • Support strategic initiatives that will address mission-critical questions and position BioNTech for future success
Knowledge & Other Requirements
  • Expert in ICH-GCP E6 (R2/R3) & ICH E8 (R1) Risk-Based Quality Management methodology, tools, industry trends
  • Represent BioNTech externally, building critical business-to-business partnerships, for example, to drive growth and innovation within the marketplace
  • Stay abreast of industry trends and intelligence regarding RBQM to ensure continuous improvement and evolution of BioNTech’s systems and processes
  • Maintains an expert presence in the industry through speaking engagements and involvement in industry committees / RBQM working groups.
  • Anticipates changes to the environment and adjusts strategy accordingly
Minimum Education & Experience
  • BA/BS/RN with 15+ years’ relevant clinical or related experience in life sciences. Or MA/MS/PharmD/Ph.D. with 12+ years’ relevant clinical or related experience in life sciences.
  • At least 5+ years in roles focused on clinical risk management or RBQM
  • When needed, the ability to travel

Benefits for you.

  • Medical, Dental, and Vision Insurance
  • Life, AD&D, STD, and LTD Insurance
  • HRA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

Job-ID 8549 (please indicate for inquiries) #DCA-LI

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you