Sr. Director, Clinical Operations

About Cerus:

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.

Summary and Scope of Position:

Strategically direct and coordinate the operational and logistical activities of Phase 2-4 clinical trials in compliance with GCP/ICH guidelines and regulatory requirements. Manage trials and programs to meet timelines and budgets consistent with Cerus business objectives. Exemplify leadership in the management of internal and external personnel and collaborate with internal functions (Quality, Data Management, Regulatory, Safety, Legal and Finance) to ensure that all deliverables are met consistent with Cerus procedures and processes.

Primary Responsibilities:

• Responsible for management of personnel (internal and external) and activities associated with the conduct of clinical trials.
• Oversee, evaluate, monitor and facilitate the flow of clinical data to meet trial milestones, and ensure data integrity and safety of subjects enrolled.
• Develop protocols, consent forms, monitoring plans, case report forms and other clinical documents related to clinical trials.
• Ensure that trial records are maintained in the electronic Master File.
• Manage investigative sites to ensure compliance with protocol, GCP/ICH , regulations and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits and/or co-monitor with CRO or contract associates.
• Negotiate contracts and budgets with clinical investigative sites and other vendors.
• Manage clinical trial budgets in collaboration with internal Cerus Finance and BARDA partners as applicable.
• Manage clinical monitoring staff (internal and/or contract) including as applicable, mentoring, coaching, staffing, and performance management.
• Participate in ongoing data review, analysis, and report writing.
• Draft investigator brochures and other regulatory documents.
• Develop DSMB charters and support DSMB activities.
• Participate in safety review and reporting, track patient enrollment and safety information for interim analysis.
• Select and manage CROs and other consultants to ensure adherence to national and international regulations and standards (GCP, MDR, ICH).
• Participate in the review and update of existing SOPs/INS’s and develop new internal guidance documents as needed.
• Interface with other departments within the Cerus organization to exchange technical data and negotiate courses of action on behalf of CRMA.
• Communicate with senior management on a regular basis on study timelines and activities.
• Maintain a high level of professional expertise through familiarity with clinical literature and participate in gathering scientific literature for protocol development.
• Participate in preparation of regulatory submissions and attend meetings as required.
• Perform other related duties as required.
• Responsible for ensuring that staff have training and demonstration through practice working knowledge and application of GCP/ICH guidelines.
  
  

Qualifications/Requirements/Skills:

• BS or equivalent experience in a scientific or medical discipline with a minimum of 10 years clinical trials management experience.
• Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors).
• Knowledge of ICH/GCP guidelines and regulations (FDA & MDR) impacting clinical development of devices.
• Regulatory inspection experience.
• Proven strong people management experience with demonstrated organizational and leadership ability.
• Previous project management experience.
• Excellent communication, interpersonal skills, and influencing skills.
• Ability to determine the people, funding, materials, and support to meet project goals and timelines.
• Clinical budget development and contract negotiation experience.
• Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs.
• Proven experience working in an ambiguous, fast-paced environment.
• Able to work independently.
• Excellent time management skills (timelines, schedules, task prioritization).
• Willing and able to travel 10%, and as needed up to 30%.
• Remote work eligible. Successful applicants may be asked to attend in-person meetings as needed, 4-6 times each year.
  
  

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

The base salary range for this position if candidate is based in the SF bay area: $260k-312k annually . Compensation may vary outside of this range depending on various factors, including a candidate’s qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.