Senior Director, Clinical Science - Oncology
BioNTech SE
4 months ago
Remote friendly (Cambridge, MA)
United States
$260,000 - $330,000 USD yearly
Clinical Research and Development
Responsibilities:
- Design clinical trials (protocols, patient populations, study endpoints) to evaluate investigational drugs’ safety and efficacy.
- Provide medical oversight of clinical trials: monitor progress, review data, and manage adverse events per regulatory and ethical standards.
- Lead or contribute to key documents including study protocols, Investigator’s Brochures, regulatory submissions, and safety updates.
- Drive strategic alignment within Clinical Development by promoting best practices and improving cross-functional processes.
- Lead the Clinical Science team (talent acquisition, onboarding, training, performance management, workforce planning).
- Collaborate across clinical operations, biostatistics, and regulatory affairs to ensure successful execution of clinical programs.
Qualifications & Requirements:
- Bachelor’s degree in life sciences or healthcare; advanced degrees preferred.
- Extensive GCP knowledge and drug development experience across Phases 1–3; oncology/immuno-oncology expertise highly desirable.
- Proven experience leading global clinical studies in pharmaceutical companies or CROs.
- Advanced skills with data management systems (e.g., EDC) focused on continuous improvement.
- Ability to work in matrixed environments and influence stakeholders without direct authority.
- Strong adaptability under tight deadlines and excellent organizational/prioritization skills.
- Excellent verbal and written communication in English.
Benefits:
- Expected US pay range: $260,000–$330,000/year + benefits, annual bonus & equity (variable, dependent on company and individual performance).
How to apply:
- Apply via the online form with your CV, copy of ID, copies of degree/professional certificates, motivation letter, and contact details.
- Only applications submitted via the online form are considered (background check may be conducted via HireRight).
- Design clinical trials (protocols, patient populations, study endpoints) to evaluate investigational drugs’ safety and efficacy.
- Provide medical oversight of clinical trials: monitor progress, review data, and manage adverse events per regulatory and ethical standards.
- Lead or contribute to key documents including study protocols, Investigator’s Brochures, regulatory submissions, and safety updates.
- Drive strategic alignment within Clinical Development by promoting best practices and improving cross-functional processes.
- Lead the Clinical Science team (talent acquisition, onboarding, training, performance management, workforce planning).
- Collaborate across clinical operations, biostatistics, and regulatory affairs to ensure successful execution of clinical programs.
Qualifications & Requirements:
- Bachelor’s degree in life sciences or healthcare; advanced degrees preferred.
- Extensive GCP knowledge and drug development experience across Phases 1–3; oncology/immuno-oncology expertise highly desirable.
- Proven experience leading global clinical studies in pharmaceutical companies or CROs.
- Advanced skills with data management systems (e.g., EDC) focused on continuous improvement.
- Ability to work in matrixed environments and influence stakeholders without direct authority.
- Strong adaptability under tight deadlines and excellent organizational/prioritization skills.
- Excellent verbal and written communication in English.
Benefits:
- Expected US pay range: $260,000–$330,000/year + benefits, annual bonus & equity (variable, dependent on company and individual performance).
How to apply:
- Apply via the online form with your CV, copy of ID, copies of degree/professional certificates, motivation letter, and contact details.
- Only applications submitted via the online form are considered (background check may be conducted via HireRight).