Clinical Trials Project Manager and Regulatory Assistant, Clinical Development

The Clinical Trials Project Manager and Regulatory Assistant, Clinical Development will have global and regional responsibilities for planning Clinical Trials. This role will lead the design, development, evaluation, planning and execution of clinical studies and ensure scientific integrity and interpretation of study data, as well as assist regulatory interactions with health authorities. Provides clinical and regulatory directions to project/study teams. This role will be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members. This role is primarily focused on Clinical Trial coordination from beginning the trial to end of trial. In order to be successful, the candidate will need to have excellent time management skills, project management skills and communication skills. Candidate must be able to work on tight deadlines and with in international time zones.

The position will be based in San Diego, CA

Responsibilities:

The Clinical Trial Project Manager and Regulatory Assistant will be responsible and accountable for the development, implementation, and delivery of the global clinical development strategy for a given project within time, budget and with high quality. This will entail leading the development of the Clinical Development Plan in collaboration with the Clinical Team and ensuring alignment with the agreed Global Development and Regulatory Strategy/ Integrated Evidence Plan.

Responsibilities include the following:

• Assists in the design of clinical studies. Responsibilities may extend from early translational development activities to mature product life cycle strategies.
• In conjunction with Clinical Leader, designs, conducts, reports clinical trials in line with the development, regulatory and commercial strategy.
• May be responsible for opinion leader development within the therapeutic area Interacts with and coordinates appropriate scientific activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going clinical studies or projects.
• Assists as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
• Assists in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specifics information. Keeps abreast of professional information and technology through conferences or medical literature and acts as a therapeutic area resource.
• Represents Arnatar at external meetings including investigator meetings, scientific association meetings, partner discussions, etc.
• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements
• May lead cross functional sub-teams responsible for defined sub-projects within the therapeutic area (individual publications or study collaborations).
• May initiate research projects compatible with project plan goals and drive them to completion, resulting in high quality publications
• Responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and publications associated with the clinical trials.
• You will participate in the development of the Clinical Development Plan by contributing the scientific/clinical/regulatory expertise for the strategy. Once completed, in collaboration with clinical operations, is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan and is responsible for acting as a key contact for the Integrated Evidence Strategy Team, and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project.
• Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members.
• Ensuring the review of clinical data, including protocol deviations.
• Interpreting and communicating, with the Clinical Program Lead, clinical trial results.

Collaborating with the clinical leaders, and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications). Project Manager manages the day-to-day operations of clinical trials, including planning, execution, and reporting, while ensuring compliance with regulations and protocols. Key responsibilities include:

• Trial Management: Overseeing clinical trial execution, including protocol development, site selection, and management.
• Regulatory Compliance: Ensuring adherence to Good Clinical Practice (GCP) and other regulatory guidelines.
• Data Management: Collaborating with data management teams to ensure accurate data collection, analysis, and reporting.
• Vendor Management: Selecting, managing, and overseeing Contract Research Organizations (CROs) and other external vendors.
• Team Leadership: Leading and mentoring a team of clinical operations professionals.
• Budget Management: Developing and managing clinical trial budgets.
• Stakeholder Communication: Communicating with internal and external stakeholders regarding trial progress.

Clinical Trial Management:

• ‍Protocol Development: Contributing to the development of study protocols and ensuring they are in accordance with company policies and regulatory requirements.‍‍
• ‍Site Selection and Management: Identifying and selecting appropriate clinical trial sites, and managing ongoing relationships with those sites.‍
• Timeline Management: Tracking and managing study timelines to ensure timely completion of trials.‍
• Data Review: Overseeing data review activities, including safety information and study metrics.‍
• Report Generation: Generating study reports, presentations, and publications to communicate findings.

Regulatory Compliance:

• GCP and Regulatory Knowledge: Maintaining a strong understanding of GCP, FDA regulations, and other relevant guidelines.
• Regulatory Document Preparation: Assisting in the preparation of regulatory documents, such as study protocols, briefing books, IB, IND/NDA, and data management plans.
• Compliance Audits: Supporting internal and external audits to ensure compliance.

Qualifications

• Relevant science degree (e.g., Masters, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Metabolic diseases, rare liver/kidney/CNS diseases, etc) preferred.
• Minimum 5-7 years of overall work experience or equivalent combination of experience and education.
• Minimum 5 years of clinical/research experience in the pharmaceutical/ biotechnology industry preferred.
• Proven track records in supporting development programs, with demonstrated strength in supporting and steering programs and initiatives through collection of critical data to enable timely decision making.
• Experiences in IND submissions and interactions with regulatory agencies (FDA, TGA, CDE, etc) are preferred
• Creativity, self-motivation, and an ability to thrive in a fast-paced, multidisciplinary biotech environment.
• Experience with siRNA and ASO platform technologies is a plus
• Excellent communication skills, collaborative team builder and leader.
• Ability to travel up to 15% of time, including international travel.

Additional Information

• We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​​

Arnatar is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

Job Type: Full-time

Pay: $105,000.00 - $145,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person