What are the responsibilities and job description for the Senior Director/Director Clinical Operations position at MCRA, an IQVIA business?
Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.
MCRA’s client, a clinical-stage biotechnology company based in Rockville, Maryland, is seeking a Director/Senior Director of Clinical Operations to join the team. This position is hybrid.
Responsibilities:
- Direct accountability for: CROs, Labs, Vendors (IP, data, biostats, MW, etc.)
- Oversees RFP process, vendor selection, negotiation, and contracts
- Owns study metrics, milestones, and budget tracking
- Ensures inspection readiness at all times
- Partners with QA for vendor and site audits
- Reports risk, budget, and trial status to executives
- Owns multiple studies or programs simultaneously
- Aligns resources, timelines, and budgets across programs
- Shapes vendor and site strategy, not just executes contracts
- Contributes to regulatory filings (INDs, safety reports, NDA/BLA support)
- Leads process improvement and SOP development
- Works closely with Leadership Team
- Manages or mentors Clinical Ops staff
- Must influence without authority across functions (Regulatory, QA, Finance)
- Acts as the external face of Clinical Ops with vendors and partners
Qualifications:
- 12 years clinical research
- 7–10 years managing trials/programs
- 4–6 years people management
- Biotech background preferred
- Multi‑therapeutic experience preferred
- Early phase experience preferred
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.