Associate Director*, Clinical Operations

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Summary

The Associate Director Clinical Operations (ADCO) is responsible for leading the Clinical Trial Teams and overlooking the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies profound experience the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. Excellent communication, problem solving skills are part of the job. S/he overlooks activities related with the heading of the project teams, 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. The ADCO will work closely with the Senior Director Clinical Operations (SDCO) to develop forward looking strategies for Clinical Operations as well as on alignment between the different programs and platforms.

Key Responsibilities

  • Contribution to development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development
  • Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training
  • Point of escalation in case of challenges in project activities with other sponsor departments or external vendors.
  • Instruction and supervision of ADCT, CTMs, CTCs, CRAs and CTAs (line Management)
  • Resource planning of the team in alignment with the SDCO
  • S/He is involved in the governance structure and oversight with CROs and vendors
  • Overlooking the process of selection and decision on participation of vendors for a clinical trial and providing the strategic sourcing approach to the individuals study team.
  • Contributing in the process of selection and decision on participation of vendors, preferred vendors and partnership vendors.
  • Oversight on overall project/program timelines and deliverables and identification future of program needs.
  • Oversight if project team has appropriate trainings and report training needs to the SDCO
  • Organization and conduct of team meetings
  • Taking care of team developments, identification of high-performance team members and working on team development together with the SDCO
  • Support the QA team during of internal audits, vendor audits and/or hosting inspections
  • Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)

Knowledge, Skills & Abilities

  • Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
  • Minimum 5 years of experience in project management, regulatory submissions and global study organizations
  • Refined colloquial and correspondence skills (written and spoken)
  • Experience in usual software (Word, Excel, Power Point, MS Project)
  • Ready to take over responsibility
  • Able to rapidly enter in action and to work under stress conditions
  • Able to motivate and lead a team/ used to work in a team
  • Able to recognize problems and provide solutions
  • Excellent organizational skills
  • Excellent communicative skills
  • Independent and pro-active way of working

What we offer

  • 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

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form. #LI-DCA

*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!

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