Vice President Clinical Operations
at EPM Scientific
in
Boston,
Massachusetts
Posted in Other 4 days ago.
Type: full-time
Job Description:
Responsibilities:
- Develop and execute clinical operations strategies to support the company's oncology pipeline.
- Experience with IND & BLA filiing experience.
- Lead multiple phase I-III oncology programs.
- Oversee clinical operations team of full-time and contract staff.
- Oversee the planning, execution, and management of all clinical trials, ensuring quality, compliance, and efficiency.
- Lead and mentor the clinical operations team, fostering a high-performance culture.
- Manage relationships with CROs, vendors, and key stakeholders to ensure operational excellence.
- Ensure adherence to regulatory requirements (FDA, EMA, ICH-GCP) and company policies.
- Collaborate with clinical development, medical affairs, regulatory, and other cross-functional teams.
- Drive clinical trial budgets, timelines, and resource allocation.
- Identify and mitigate risks in clinical programs to ensure seamless execution.
- Represent the company in key external meetings, including regulatory agency interactions.
Qualifications:
-
Advanced degree (MD, PhD, PharmD, or MSc) preferred; Bachelor's degree required in life sciences or a related field.
-
10+ years of clinical operations experience, with at least 5 years in a leadership role within oncology biotech or pharma.
- Strong knowledge of global clinical trial regulations and guidelines (FDA, EMA, ICH-GCP).
- Proven ability to manage complex clinical trials and drive operational efficiencies.
- Experience leading and managing high-performing clinical operations teams.
- Strong financial acumen with experience managing clinical budgets.
- Excellent communication, leadership, and problem-solving skills.
- Ability to thrive in a fast-paced, dynamic biotech environment.