Executive Director, Clinical Operations

Therapeutics Inc.; San Diego (CA); Hybrid; USD 210,000 - 220,000; Full time

Job summary

Ein etabliertes Unternehmen in der Dermatologie sucht einen Executive Director für klinische Operationen, der die Gesamtstrategie und Ausführung klinischer Studien leitet. Diese Schlüsselrolle erfordert umfangreiche Erfahrung in der klinischen Studienleitung, Projektmanagement und Teamführung. In einem dynamischen Umfeld werden Sie für die Entwicklung von Studienplänen, die Überwachung des Budgets und die Zusammenarbeit mit internen sowie externen Stakeholdern verantwortlich sein. Wenn Sie leidenschaftlich an klinischen Studien interessiert sind und eine Führungsposition anstreben, ist dies Ihre Chance, einen bedeutenden Einfluss auf die Entwicklung innovativer Therapien zu haben. Bewerben Sie sich jetzt und werden Sie Teil eines wertschätzenden Teams!

Qualifications

• Mindestens 15 Jahre Erfahrung in klinischen Operationen, davon 8 Jahre in der Studienleitung.
• Vertrautheit mit FDA- und ICH-GCP-Richtlinien.

Responsibilities

• Leitung der klinischen Operationsstrategie und Management von Studien.
• Entwicklung und Umsetzung von SOPs und Prozessen.

Skills

Projektmanagement

Führungskompetenz

Budgetüberwachung

Kommunikationsfähigkeiten

Detailgenauigkeit

Education

Bachelor in Biowissenschaften oder verwandten Bereichen

Master in Biowissenschaften oder verwandten Bereichen

Tools

EDC-Systeme

Klinische Studienmanagement-Software

Job description

Who Are We?

Founded in 1997 and built upon 27+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Executive Director, Clinical Operations?

Reporting to the Senior Vice President of Clinical Development, the Executive Director of Clinical Operations is responsible for oversight of the overall clinical operations strategy, execution and management of clinical studies.

Your Main Responsibilities and Duties Include:

• You will be responsible for driving and leading the successful execution of all operational components of the Company’s clinical programs utilizing strong project management, leadership, and organizational skills; partnering with internal and external stakeholders to drive robust data-driven decisions.
• You will be accountable for operational execution and strategy across multiple clinical programs, including developing and executing study plans, driving efficient start-up activities and study recruitment, and trial site management.
• You will lead the development and continuous improvement of SOPs, functional systems, processes, tools relevant to the Clinical Development organization and adherence to established laws, regulations, and guidelines.
• Key activities include strategy and planning towards milestones, managing the supporting clinical operations team, hands-on management of external vendors, driving critical path activities, proactively identifying issues and resolving conflicts.
• Additionally, you will be responsible for programmatic resource and financial planning / forecasting and budget management.
  
• You will collaborate with internal and external stakeholders to ensure strategic alignment of objectives, develop operational strategy, and execute clinical programs on time and within budget.
• You will review and approve study-related materials including protocols, informed consent forms, monitoring plans, site training materials, EDC/case report forms, study, lab and pharmacy manuals, data management plans, monitoring reports, etc. as needed.
• You will oversee study-related activities including site identification and selection, enrollment models, clinical supply planning and drug supply, lab kits, investigator and vendor meetings, development of systems, review of data during the study, data cleaning, database lock, etc.
• You will proactively identify project risks before they arise and develops contingency plans; escalate issues related to quality, timelines, and budget and provide recommendations.
• You will collaborate with legal and finance (and others as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, contract negotiation and development, clinical trial agreements, payment terms, milestones, etc.)
• You will directly mentor, coach and develop senior level clinical operations staff.

To Succeed in this Position:

• You should have at least 15 years of experience working in a clinical operations role, with at least 8 years in study management. At least 5-7 years in direct people management is preferred. Experience working in dermatology or ophthalmology drug development ideal but not required.
• You should have at least 10 years of experience with monitoring of budget and progressive clinical trial management across the full-cycle of drug/device development (e.g. Phase 1 through Phase 4, etc.). Solid understanding of drug/device development is required.
• You should have a proven track record of leadership and success at the Senior Director level.
• You should have a good project management and organizational skills, attention to detail and time-management.
• You should have a good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
  
• You should have excellent verbal and written communication skills.
• You should be a team player who is willing to roll up your sleeves to get the job done.
  
• Ideally, you will have CRO experience.

The most likely base pay range for this position is $210,000 to $220,000 per year. Range dependent on experience.

Please note this is a San Diego based position. Candidates will be required to be onsite per our Company's hybrid schedule.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.If you are smart and good at what you do, we welcome you to apply!