Clinical Trial Manager

**Role**: Director of Clinical Trials
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Acorn Biolabs is a personalized regenerative medicine company enabling individuals to leverage the power of their own cells in cosmetics, injury recovery and general health.

First, we offer a cell preservation service. As we age, so do our cells; over time, they become more damaged and less capable. This means that when we need our cells the most, they may be too old and ineffective to receive the full benefits of regenerative treatments.

Acorn helps with this. We provide a solution to allow individuals to collect and cryogenically freeze their own cells, sourced non-invasively from hair follicles. This halts the effects of aging, providing you with a collection of your own younger cells, ready for the future of regenerative medicine.

Next, Acorn not only acts as your cell cryopreservation resource but is also actively developing cell-based therapies, first in cosmetics and soon in general health. We have recently launched our services by partnering with Dermatologists, Plastic Surgeons, MedSpas, and Wellness Centers across North America.

**The Role**

We are seeking a highly motivated and experienced Director of Clinical Trials reporting to our CEO to join our dynamic team. As a Director of Clinical Trials at Acorn Biolabs, you will play a crucial role in managing and overseeing the successful execution of our single-site studies focused on cosmetics as well as clinical trials focused on aesthetic medicine and soon general health, while ensuring compliance with regulatory guidelines and maintaining the highest standards of quality and ethics.

Our values are important to us and set the culture of our company.
- Integrity first
- In our science, with our clients, with each other. Always.
- Collaborate
- Be kind, supportive, respectful, and inclusive. Be humble and grateful.
- Show up
- Take pride in your work. Be dependable, accountable, and disciplined. Strive for excellence - and be agile. Add value.
- Be curious
- Ask why. Constantly learn. Create. Innovate.
- Have fun
- Enjoy life Laugh - at yourself and with others. Be passionate about your work.

**Location: Toronto / Los Angeles / Remote work arrangements possible**

**What You’ll Do**
- Trial Planning and Design:

- Collaborate with cross-functional teams to develop and refine trial protocols, ensuring scientific rigor and alignment with strategic objectives - specifically in the cosmetics and aesthetics space.
- Create detailed project plans, including timelines, milestones, and resource allocation, to ensure timely execution of trials.
- Participate in study feasibility assessments and provide input on recruitment strategies.
- Study Oversight and Management:

- Serve as the primary point of contact for internal and external stakeholders involved in trials, including clinic partners, investigators, study sites, contract research organizations (CROs), and regulatory authorities.
- Coordinate and conduct patient interviews and surveys.
- Monitor and supervise study progress, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Manage and review study-related documentation, such as informed consent forms, case report forms, and study reports, with a focus on the unique requirements of cosmetics and aesthetics trials.
- Conduct regular site visits and/or coordinate monitoring activities to ensure data integrity, safety, and regulatory compliance.
- Regulatory Compliance and Collaboration:

- Collaborate with regulatory authorities, such as the FDA and Health Canada, to ensure compliance with applicable regulations and guidelines for cosmetics and aesthetics clinical trials.
- Establish and maintain effective working relationships with regulatory authorities to facilitate the approval process and ensure regulatory compliance throughout the trials.
- Team Leadership and Collaboration:

- Foster a positive and collaborative work environment, promoting open communication and knowledge sharing within the clinical operations team.
- Provide guidance and support to team members, ensuring their professional development and adherence to company and industry standards specific to cosmetics and aesthetics trials.
- Risk Assessment and Mitigation:

- Identify potential risks and issues specific to cosmetics and aesthetics trials during planning and execution phases, developing mitigation strategies and contingency plans as needed.
- Implement risk management processes, including the assessment, tracking, and resolution of study-related issues in the cosmetics and aesthetics field.
- Foster a culture of safety and ethical conduct, prioritizing patient welfare and regulatory compliance throughout the clinical trial process.

**What You’ll Need To Succeed**
- Master of Science (MS) or Doctor of Philosophy (PhD) degree in Clinical Medicine, Biology, Microbiology, Biochemistry, or related areas.
- Minimum of 5 years of experience