Director, Clinical Development

Company Overview

ADARx Pharmaceuticals, Inc., located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and oligonucleotide delivery technologies for inhibition, degradation, and editing disease-causing mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system diseases. We are well-financed by a syndicate of renowned VC firms.

ADARx currently has multiple active programs in development. Our lead candidate is at the clinical stage.

Director, Clinical Development

Job Description:

We are seeking an exceptional and highly motivated clinical leader as Director/Senior Director, Clinical Development, responsible for leading multiple clinical programs including our first asset at the clinical stage, and additional assets planned for 2023.

Responsibilities

• Responsible for the design, execution, analysis, interpretation, and reporting of clinical studies/programs.
• Provide the medical and clinical perspective in strategic plans and decisions including helping to continue to build the ADARx therapeutic pipeline.
• Direct and oversee the overall strategy for Clinical Development, collaborating with Regulatory in IND, CTA and NDA submission activities.
• Work closely with all functions of the organization and external partners to manage trial logistics.
• Directly supervise and monitor trial conduct to ensure patient safety and data integrity.
• Serve as a Medical Monitor for early clinical studies, FIH and POC studies.
• Inform the ADARx drug development process with clinical understanding of each target indication, acquired through literature research, KOL engagement, attendance at conference, patient advocacy meetings, etc.
• Work closely with translational, preclinical and platform technology scientists in the advancement of clinical candidates.
• Participate in the identification of opportunities for external collaboration.
• Lead/author of clinical portion of regulatory submissions and responses to regulatory agency questions and, where appropriate, serve as the company representative for regulatory interactions.
• Serve as a key liaison between ADARx and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.
• Communicate scientific findings via verbal and written communications and visual presentations both internally and externally.
• Build and foster a network of external alliances across academia, industry and patient advocacy groups.
• Duties as assigned.

Essential Physical Characteristics:

Reasonable accommodations 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

• Proven track record in leading clinical trials and development in a pharmaceutical company or biotech company
• M.D. or equivalent degree is required
• 3-10 years of experience in Clinical Development at a biotech or pharmaceutical company.
• Therapeutic area experience in rare genetic disease is desirable.
• Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach work effectively in a dynamic and collaborative, fast-paced environment.
• 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.
• Demonstrated critical thinking and sound decision-making.
• Track record of scientific achievement demonstrated by peer-reviewed publications.
• Proficiency working with Microsoft Word, Excel, Outlook, PowerPoint
• Excellent interpersonal and public speaking skills

Preferred Qualifications:

• Ph.D. is a plus.
• Early Clinical Development experience is highly valued.
• Modality experience with RNA targeting and gene therapies is a plus but is NOT required.
• Broad therapeutic experience in Phase I-III Clinical Development experience is ideal.

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
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• Background Check
• United States (Required)

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:

• 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.