Job Description:
We are seeking a highly motivated and qualified leader to join our Clinical Department as a Clinical Project Director (CPD) and work as a team lead to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced, high-growth, and innovative team. The Clinical Project Director will lead ongoing RNA-based drug discovery projects and be the “clinical trial execution expert” within a matrix management team structure.The Clinical Project Director primary responsibilities include hands-on management of all aspects of clinical trial planning and execution, overseeing work performed by outside global vendors, and leading groups of internal and external personnel to achieve company objectives.
The successful candidate will have demonstrated key core competencies around accountability, leadership and teamwork, communication, problem-solving, decision-making, and conflict resolution. The CPD will be a key member of the clinical development team and plays the central driving role in the success of our therapeutic candidates. As ADARx pipeline grows, the successful candidate has exciting opportunities to grow in their leadership and build out of teams.Essential Responsibilities:
- Work as project/program team lead alongside cross-functional SMEs to drive key assets through development.
- Lead the global operationalization of the clinical development plan(s) including development and implementation of clinical project plans and timelines that align with company objectives and focus on operational excellence.
- Develop and manage the overall clinical trial budget.
- Oversee the management of the global clinical trial aspect for project/program teams to ensure all trial results are met according to timelines, budget, quality standards and operational procedures, report study progress and issues with their mitigation plan.
- Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
- Manage cross-functional project team meetings, including scheduling, agenda setting and preparing minutes from each meeting.
- Act as the primary point of contact with CRO and study vendors, facilitating contract review for sites, vendors, and CROs and monitoring adherence to scope of work.
- Plan and present at investigator meetings, company, and other meetings as required.
- Participate in vendor, site and CRO selection process and audits, as applicable
- Contribute to key study documents (e.g., protocols, IBs, CSRs, etc.) in conjunction with other SME functions.
- Participate in the development, review and implementation of clinical SOPs.
- Ensure clinical trial compliance with all appropriate SOPs and GCP/ICH guidelines.
- Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time, within budget or to agreed quality standards.
- Develop risk management and mitigation plans and regularly evaluate and communicate the probability and impact of risks to program deliverables
- Provide regular study updates and present to leadership.
- Optimize clinical operations function by streamlining and implementing systems and processes for maximum efficiency.
- Where appropriate, recruit, hire, and line manage Clinical Operations professionals to ensure effective execution of clinical project plans and company goals.
Essential Physical Characteristics:Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.On-Site Protocol:Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.Qualifications:
- Bachelor's degree in scientific discipline, advanced degree or PMP preferred.
- Minimum of 12 years’ experience in drug development, clinical operations strategy including responsibility for ensuring studies and programs are executed to quality, timelines, and budget (at least part of this time in a Biotech environment is preferred); prior global clinical trial experience is required.
- Multi-study experience managing early through late-stage clinical trials.
- Experience across several rare or complex therapeutic areas
- Working knowledge of and experience with clinical conduct, GCPs; FDA, EMA regulations.
- Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
- Strong problem-solving skills and a proactive attitude towards exploring new approaches.
- Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
- Up to 10% Travel
- Proficiency working with Microsoft Office Suite Products.
Compensation:
- This is a full-time position, Monday-Friday, occasional overtime.
- Pay is commensurate with experience.
- Equity-based compensation
- Performance-based bonuses
- 401(k) with Company Match
- Medical, Dental, Vision
- Flexible Spending Account
- Life Insurance
- Employee Assistance Program
- Employee Discounts
- Gym Membership
- Paid Vacation
- Paid Holidays
- Paid Sick, Jury Duty, Bereavement
Work Authorization:
- United States (Required)
- Background Check
- As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
Company Overview:
We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Disclosure Statement:
- The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
- Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
- The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
- Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
- Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
206512.00 To 230400.00 (USD) Annually
