Associate Director*, Clinical Trials
The Associate Director Clinical Trials (ADCT) is responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with the heading of a project team, the supervision/ control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.
- Support in preparation of regular status reports to SDCO and ADCT / Chief Medical Officer (CMO), including presentation of project status in meetings
- Overlooking the clinical operation trial budget
- Opportune contact with PM and ADCO in case of divergences from the project plan
- Oversight on project timelines and deliverables
- Set-up or oversight of study related documents such like Study Management Plan, Monitor Manual, etc.
- Contribution to and review of study core documents, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
- Supervision/ quality control of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training
- Co-ordination of project activities with other sponsor departments
- Instruction and supervision of CTCs, CRAs and CTAs (in the scope of a project)
- Point of contact in case of problems within the clinical trial
- Support in planning and conduct of project training prior to starting project activities, oversight if project team has appropriate trainings and report training needs to the ADCO
- Organization and conduct of study team meetings
- Review of all clinical trial activities from start-up to close out
- Responsibility for oversight of the Trial Master File (paper or electronic) during the clinical trial and initiation or performance of regular QC checks
- Processing of all relevant issues of the national and international ethics committees and regulatory authorities in adherence to the timelines
- Support in the process of selection and decision on participation of investigator sites
- Organization and participation in investigator meetings
- Oversight and handling of contract negotiations with trial sites/ pharmacies/ local labs in Germany, correspondence with legal.
- Co-monitoring if planned in the scope of a project
- Support of internal or site audits and/or hosting inspections in the scope of a project
- Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)
- Minimum 5 years of experience in project management, regulatory submissions and global study organizations
- Very good English (written and spoken)
- Experience in usual software (Word, Excel, Power Point, MS Project)
- Readiness to proactively assume responsibility
- Quick to action in a fast paced environment
- Demonstrated project team leadership
- Management of external vendors and external teams
- Solution orientation and problem solving mindset.
- Excellent organizational skills
- Excellent communicative skills
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & 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 free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
- And more!
To Apply, EEO and BioNTech Websites
*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