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BioNTech SE · 2 weeks ago

Executive Director, Clinical Science

Cambridge, MA

Full-time

Onsite

Director/Executive

15+ years exp

BioNTech SE is a leader in clinical science, seeking an Executive Director of Clinical Science to lead their Clinical Center of Excellence. The role involves overseeing clinical studies, managing a team of Clinical Scientists, and ensuring high-quality delivery of clinical protocols and data while fostering a culture of innovation and excellence.

Health Care

Responsibilities

Supports resource forecasting, talent development, succession planning, and retention strategies

Builds a collaborative, supportive learning environment

Ensures and contributes to a consistent and high level of training for Clinical Scientists across the department with respect to relevant scientific data and knowledge, including SOPs and Working Practices

May serve as a delegate for Clinical Development Portfolio VPs as needed

Partners with Clinical Development VPs to advance the portfolio/pipeline

Leads teams to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings

Oversees the portfolio/pipeline of clinical studies to ensure consistency of clinical deliverables across program(s)

Ensures high quality and timely delivery of protocols and data; implements quality assurance plans in collaboration with the QA organization

Partner with QA and GDO to develop vision for embedding and operationalizing Quality by Design throughout the trial lifecycle

Develop metrics and collect indicators that enable ability to track output and trends associated with protocol development and can be applied to identify areas of continuous improvement

Serve as clinical science/development subject matter expert to support quality and compliance efforts across the therapeutic areas and guide compliance to GCP. Interface with key stakeholders across other departments to support a culture focused on quality across BioNTech

Maintains an advanced understanding of the status of all trial activities

Champions clinical trial innovation such as novel study designs, dose escalation methods, decentralized trials, EMR to EDC, generative AI, data science and real-world data, and other approaches to accelerate clinical trials and reduce the burden on patients and sites

Serves as an internal subject matter expert on the latest best practices, industry standards, and novel approaches in clinical science/development excellence

Leads resourcing and budget planning activities for the Clinical Science/Development organization, including contractors and Functional Service Providers

Lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitioners

Lead team focused on developing and maintaining clinical processes across Early and Late Development and serve as senior voice in supporting quality and compliance-related activities

Holds accountability for the performance and professional development of the Clinical Scientist team

Serves as a key cross functional collaborator; represents the Clinical Science function and/or the entire clinical Development function in various process improvement initiatives and/or cross functional activities

Collaborates to support incoming asset and/or business development activities (i.e., due diligence)

Qualification

Clinical Science expertiseClinical trial innovationPortfolio managementLeadership skillsProcess improvementRegulatory complianceTeam managementTalent developmentEffective communicationCollaborationConflict management

Required

An advanced scientific degree is required (PhD, PharmD, or MD) with a minimum of 15 years of related experience

Experience managing clinical teams accountable for delivery of a portfolio of studies

Proven track record of leadership, people management, enterprise mindset, developing and executing on a vision for an organization, talent strategies and process improvement

Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally

Good judge of talent; can articulate strengths and limitations of people; provides challenging tasks and assignments, holds frequent development discussions; is aware of each person's career goals and constructs compelling development plans; is a people builder

Promotes a culture of scientific excellence, multidisciplinary problem solving, urgency, teamwork, consistency, flexibility, execution, quality and effective communication

Anticipates needs, assesses and manages business and organizational risks

Demonstrates strong leadership presence, expert financial acumen

Shares wins and success; fosters open dialogue; define success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team

Take personal responsibility for results, pushing self and others to exceed goals and deliver results

Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational changes

Recognized internally and externally as technical/functional expert with strong leadership skills in the clinical science field and related disciplines

Fosters an environment where continuous improvement and innovation are embedded in day-to-day operations

Able to act as mentor/coach to others to improve team members conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; manages to obtain agreements in a challenging environment and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular

Encourages acceptable levels of risk-taking towards driving innovation; determines acceptable levels of risk for own business segment or function