Associate Director Clinical Operations PC 864

Miltenyi Biotec•Waltham, MA

1d•Hybrid

About The Position

This position is a key leadership role that will provide support and guidance to clinical trial teams whose objectives are to deliver innovative advanced therapy clinical trials consistent with Miltenyi Biomedicine values and goals. This role will also be responsible for collaborating with internal cross-functional teams, clinical sites, and CRO partners to execute global clinical programs in a safe, ethical, and compliant manner. Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T-cell therapies. We are developing innovative treatments for serious life-threatening diseases and are reshaping their accessibility to patients worldwide with the goal of improving and prolonging patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases.

Requirements

Bachelor’s Degree – Life Sciences
10+ years progressive related work experience, at least 5 of which were with a biopharmaceutical (Sponsor) organization.
Prior experience overseeing CRO selection and contracting processes.
Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
Excellent written and verbal communication.
Ability to collaborate cross-departmentally and cross-functionally.
Effective in objective data management know-how, data interpretation and communication as well as expression of abstract ideas to all levels of the organization.
Strong interpersonal and conflict resolutions skills.
Effective decision making and delegation skills.

Nice To Haves

Prior clinical CRO, trial site, or research experience in advanced therapies also desirable.

Responsibilities

Ensure safe, ethical, and compliant clinical trials as per ICH GCP, federal, international, local, and otherwise applicable regulatory agency requirements.
Share a broad view of Miltenyi Biomedicine’s goals and performance.
See beyond personal and functional benefit, champions company and team decisions within trials being conducted in the US and abroad.
Ensure alignment of individual trial goals, plans, key performance/ risk indicators, management of forecast and study budgets, and trial timelines with departmental and company objectives.
Collaborate with US, EU, and international colleagues, CROs, and investigators to identify risks and formulate effective clinical trial plans.
Responsible for forecast and management of individual trial budgets / timelines, as well as CRO management and investigator interactions.
Execute to plan and as unanticipated risks or challenges arise, adjusts by working with colleagues within Clinical and QA, CROs, and investigators toward resolution.
Work within cross-functional team to develop high-quality study deliverables (e.g., Protocols, CRFs, SAPs, CSRs, cell handling manual, etc.)
Evaluate team and company KPIs, KRIs, existing best practices, and SOPs; identifies gaps and proposes solutions to ensure fit for purpose and compliance.
Contribute to regulatory filings in the US and internationally.
Lead by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.
Work with leadership to define project staffing plans, talent development, and talent acquisition.
Regularly interacts with senior management on project-related matters and department best practices.
May direct a team to achieve departmental/organizational goals.