Executive Director, Clinical Science

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US   |   full time   |   Job ID: 9743 

SUMMARY/JOB PURPOSE: The Executive Director (ED) of Clinical Science and Clinical Center of Excellence leads a best-in-class Clinical Science and Center of Excellence function at BioNTech to provide scientific and process expertise necessary to design and deliver early and late phase clinical studies. The ED of Clinical Science and Clinical Center of Excellence serves as a member of the Global Development Leadership Team. S/he manages a team of Clinical Scientists who are accountable for best practices in the design and conduct of clinical studies, clinical document excellence, medical data integrity, medical monitoring and clinical trial innovation. The ED of Clinical Science and Clinical Center of Excellences oversees the pipeline (portfolios) of clinical programs and process improvement initiatives impacting the Clinical Development organization and ensures cross-functional teams are formed, objectives set, and timelines achieved. S/he recruits highly qualified leaders and individual contributors to the organization as well as establishes the vision, mission, and culture of the team. 

ESSENTIAL DUTIES AND 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)

SUPERVISORY RESPONSIBILITIES:

• Functional head role, manager of managers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• 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

Knowledge/Skills:

• 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 of 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.

JOB COMPLEXITY:

• Functional leadership with broad accountability
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
• Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.

WORKING CONDITIONS:

20% Travel required

Your Benefits:

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.

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.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.