Assoc. Director/ Director, Clinical Operations

Reporting:

Andrew Marsh, VP/ Head, Clinical Development Operations

Description:

Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors.  We are at the vanguard in developing best-in-class alpha- and beta-emitting radioligands that target cancer, while mitigating destruction to healthy tissue and cells.  We have built a fully-integrated, leading radiopharmaceutical platform, bringing together novel target biology insights, innovative multimodal ligand discovery, and enabling translational infrastructure.

We are actively seeking talented individuals to join us who are looking to make an impact in science and in the lives of cancer patients.  Our team is a collective group who is excited about being part of building a successful biotech company, and in honing their knowledge and experience to enhance their careers.

We have just moved into beautiful new offices in Arsenal Yards in Watertown, MA. In our new home we now have our office space, research labs, and GMP manufacturing suite all in one place.

We are seeking an experienced Associate Director, Clinical Operations to join Mariana’s Clinical Development Operations organization. S/he will be responsible for overseeing all aspects of clinical trial activities on assigned studies. This will include managing outside vendors in the execution of clinical trials and development of relationships between the Sponsor and site personnel.

Illustrative Breadth of Responsibilities:

• Plan and implement clinical research studies within budget and on schedule.
• Manage activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
• Coordinate and lead study team meetings and update the Clinical Team on timelines and milestones for the study.
• Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
• Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
• Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data.
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
• Review and negotiate contracts.
• Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
• Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
• Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.

Requirements/Skills:

• Bachelor’s Degree or equivalent in health-related field is required
• 7+ years’ industry experience
• Experience in oncology is highly desirable
• Strong oral and written communication skills with monitoring, study management, and SOP-development experience Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements
• Be highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications
• Quality (GCP) and/or Data Management experience is a plus
• Be able to work independently under general direction in a fast-paced environment

Mariana Oncology’s Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions

What Success Looks Like at Mariana Oncology

Entrepreneurial Mindset: We are all working in an exciting and new space of life sciences, and the only way we’re going to be successful is by working together. We will be tested in ways that require us to improve our skills, learn from our mistakes, and take continuous action on ideas. By sharing our work, explaining our processes, and highlighting the takeaways we derive from our experiments, we will all learn and grow as a team.

Believing the Glass is Half-Full and Having Self-Confidence: 

We need you to bring all your courage and willingness to advocate positions based on doing the right things; identify and focus on the positives and potential of every business and scientific opportunity. There will be times when we’re in uncharted territory and working without a lot of direction. When things get challenging, we must look out for each other. Sometimes, even something as simple as saying, “thank you” or “great work” can go a long way.

Leadership:

We’re looking for role models who can think and work across the enterprise and inspire others to perform at their very best. If you are passionate about improving the lives of people suffering from cancer, empowering others, and being a positive force for change, the join us. Together we can defeat cancer’s toughest tumors!