Senior Director Clinical Operations - REMOTE

Proclinical is seeking a remote Senior Director Clinical Operations for a leading biotech company.

Job Responsibility:

• Provides operational leadership and input in collaboration with the cross-functional leadership team for planning, development, and execution of oncology clinical programs
• Communicates clinical operations metrics, strategies, and key updates to the leadership team.
• Oversees internal (eg, direct reports, cross functional teams, etc.) and external functions (eg, CRO, vendors, clinical investigators, etc.) to ensure clinical operations deliverables are met within the expected timelines, within budget, and up to the standards of quality set
• by key stakeholders. Serving as a clinical operations liaison, resource, or key point of contact.
• Develops, reviews and approves essential clinical study documents (eg, clinical protocol, informed consent forms, documents supporting health authority submissions, study plans, vendor manuals, etc.).
• Oversees the identification and selection of vendors, including requests for proposals, bid defenses, review of contracts, budgets, and decision-making on selection.
• Oversees the identification and selection of clinical sites based on feasibility, qualification to ensure that the inclusion of sites is optimal for meeting study enrollment goals, timelines, and quality of data.
• Develops, reviews and approves department and/or cross-functional standard procedural documents.
• Initiates and provides operational oversight of workstreams to optimize department and/or cross-functional processes.
• Manages people and teams, including recruiting and hiring of resources in accordance with the resource plan.
• Provides mentorship for professional development.
• Perform other duties and special projects as assigned.

Skills and Requirements:

• BA/BS or equivalent degree; Advanced degree preferred.
• Minimum 8 years of direct experience in global clinical drug development setting, including oncology clinical trials and direct clinical operations experience; prior management/supervisory experience preferred.
• Excellent interpersonal, verbal and written communication skills, while being able to work and think independently, to support a collaborative work environment.
• Must display effective analytical and problem solving skill; and be able to proactively identify and communicate risks and/or other issues and develop appropriate mitigation, action plans, or solutions in collaboration with key stakeholders.
• Proficient clinical research knowledge and cross-functional understanding of clinical trial methodology with proven ability to execute clinical trials within expected timelines and budget.
• Experience with managing and selecting CROs and other clinical trial vendors (eg, central lab, central imaging, etc.).
• Thorough knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.
• Highly developed leadership skills to successfully lead complex clinical programs. Able to effectively build and lead high-functioning teams.
• Ability to deal with time demands, incomplete information or unexpected events
• Attention to detail.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Highly competent knowledge of transplant patient care and apheresis collection a plus.
• Hires, leads, and develops staff

If you are having difficulty in applying or if you have any questions, please contact Laissa Lang at (+1) 347-227-1672 or l.lang@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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