Futureshaper.com
Senior Director, Clinical Science - Oncology
Futureshaper.com, Cambridge, Massachusetts, us, 02140
Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID:8977
Responsibilities
In collaboration with the Clinical Development Lead, develop the design of clinical trials to evaluate the safety and efficacy of investigational drug. This includes developing the study protocol, identifying patient populations, and selecting study endpoints. Support the Clinical Development Lead in the medical oversight of clinical trials to ensure that they are conducted in accordance with the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed appropriately. Contribute to and/or lead the creation of study-level documents, including protocol development, preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable). Under guidance of Clinical Development Lead, address regulatory/health authority queries and ensure compliance with guidelines. Contribute to the development of the Clinical Development Plan, Integrated Evidence Plan and the clinical component of the TPP. Facilitate alignment within Clinical Development by promoting best practices and driving cross-functional process enhancements. Provide strategic leadership to the Clinical Science team, overseeing talent acquisition, onboarding, training, workforce planning, performance management, and talent development. Collaborate with cross-functional teams, including, but not limited to, clinical operations, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs. Build and foster relationships with PIs and Key Opinion Leaders (KOLs) in relevant therapeutic areas. Develop training materials to support the understanding of the clinical trial protocol and/or disease indication. Provide training to study team members, CRO staff, investigator staff, etc. Present at key meetings (e.g., SIVs, investigator meetings, IDMC meetings). Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection. Contribute to aggregate reports, patient narrative reviews, and pharmacovigilance monitoring meetings. Support regulatory activities, like preparation of meetings with regulatory agencies. Support preparation and (if applicable) participate in study level meetings, for example Investigator Meetings, Data Monitoring committees, and others. Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/sites). This could also include support for Case Report Form (CRF) development and data capture tools. Oversee the medical data review and analysis of clinical trial data across a platform/indication/asset to evaluate the safety and efficacy of investigational drugs. This includes working with biostatisticians to develop analysis plans, reviewing study data, and interpreting study results. Improve quality of reviews/insights with emphasis on subject safety, data integrity, trend identification, analysis and remediation. Provide insights and facilitate data review process improvements, for example by identifying redundant reports and implementing innovative data analysis processes and tools. Line management of clinical science personnel, including development, coaching, and performance evaluations. Qualifications
Bachelor’s degree in life sciences, healthcare, or nursing required; advanced degree strongly preferred. Minimum of 12 years of relevant industry experience, with a proven track record in clinical development. Demonstrated experience in leading and managing high-performing teams. Extensive knowledge of Good Clinical Practice (GCP) guidelines and comprehensive understanding of drug development processes across Phases 1–3, with a strong preference for expertise in Oncology and Immuno-Oncology. Significant experience in the design, organization, and execution of global clinical studies within pharmaceutical companies, CROs, or academic research settings. Deep understanding of clinical data collection and reporting principles; advanced proficiency with data management systems and analytical tools (e.g., EDC systems, Microsoft Excel), including the ability to optimize and innovate processes for continuous improvement. Proud ability to work effectively in a matrixed environment and influence stakeholders at all organizational levels without direct authority. Excellent flexibility, adaptability, and the capacity to manage multiple priorities simultaneously. Proven track record of working under tight deadlines while upholding high-quality standards. Strong organizational skills with the ability to prioritize and implement tasks. Excellent verbal and written communication skills in English. Compensation and Benefits
Expected Pay Range (US): $260000/year to $330000/year + benefits, annual bonus & equity (bonus and equity are variable and dependent on company and individual performance). Your Benefits: Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Auto & Pet Insurance Apply now - We look forward to your application! Apply for our Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany location and simply send us your documents using our online form. 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. BioNTech will conduct the background check through our service provider HireRight. You will be informed accordingly by your BioNTech-Recruiter.
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In collaboration with the Clinical Development Lead, develop the design of clinical trials to evaluate the safety and efficacy of investigational drug. This includes developing the study protocol, identifying patient populations, and selecting study endpoints. Support the Clinical Development Lead in the medical oversight of clinical trials to ensure that they are conducted in accordance with the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed appropriately. Contribute to and/or lead the creation of study-level documents, including protocol development, preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable). Under guidance of Clinical Development Lead, address regulatory/health authority queries and ensure compliance with guidelines. Contribute to the development of the Clinical Development Plan, Integrated Evidence Plan and the clinical component of the TPP. Facilitate alignment within Clinical Development by promoting best practices and driving cross-functional process enhancements. Provide strategic leadership to the Clinical Science team, overseeing talent acquisition, onboarding, training, workforce planning, performance management, and talent development. Collaborate with cross-functional teams, including, but not limited to, clinical operations, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs. Build and foster relationships with PIs and Key Opinion Leaders (KOLs) in relevant therapeutic areas. Develop training materials to support the understanding of the clinical trial protocol and/or disease indication. Provide training to study team members, CRO staff, investigator staff, etc. Present at key meetings (e.g., SIVs, investigator meetings, IDMC meetings). Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection. Contribute to aggregate reports, patient narrative reviews, and pharmacovigilance monitoring meetings. Support regulatory activities, like preparation of meetings with regulatory agencies. Support preparation and (if applicable) participate in study level meetings, for example Investigator Meetings, Data Monitoring committees, and others. Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/sites). This could also include support for Case Report Form (CRF) development and data capture tools. Oversee the medical data review and analysis of clinical trial data across a platform/indication/asset to evaluate the safety and efficacy of investigational drugs. This includes working with biostatisticians to develop analysis plans, reviewing study data, and interpreting study results. Improve quality of reviews/insights with emphasis on subject safety, data integrity, trend identification, analysis and remediation. Provide insights and facilitate data review process improvements, for example by identifying redundant reports and implementing innovative data analysis processes and tools. Line management of clinical science personnel, including development, coaching, and performance evaluations. Qualifications
Bachelor’s degree in life sciences, healthcare, or nursing required; advanced degree strongly preferred. Minimum of 12 years of relevant industry experience, with a proven track record in clinical development. Demonstrated experience in leading and managing high-performing teams. Extensive knowledge of Good Clinical Practice (GCP) guidelines and comprehensive understanding of drug development processes across Phases 1–3, with a strong preference for expertise in Oncology and Immuno-Oncology. Significant experience in the design, organization, and execution of global clinical studies within pharmaceutical companies, CROs, or academic research settings. Deep understanding of clinical data collection and reporting principles; advanced proficiency with data management systems and analytical tools (e.g., EDC systems, Microsoft Excel), including the ability to optimize and innovate processes for continuous improvement. Proud ability to work effectively in a matrixed environment and influence stakeholders at all organizational levels without direct authority. Excellent flexibility, adaptability, and the capacity to manage multiple priorities simultaneously. Proven track record of working under tight deadlines while upholding high-quality standards. Strong organizational skills with the ability to prioritize and implement tasks. Excellent verbal and written communication skills in English. Compensation and Benefits
Expected Pay Range (US): $260000/year to $330000/year + benefits, annual bonus & equity (bonus and equity are variable and dependent on company and individual performance). Your Benefits: Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Auto & Pet Insurance Apply now - We look forward to your application! Apply for our Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany location and simply send us your documents using our online form. 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. BioNTech will conduct the background check through our service provider HireRight. You will be informed accordingly by your BioNTech-Recruiter.
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