Executive Director, Clinical Development at ADARx Pharmaceuticals Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development, Obesity, Metabolic Disease, Clinical Trials, Regulatory Compliance, Leadership, Strategic Planning, Clinical Operations, Data Interpretation, Project Management, Communication, Team Collaboration, Problem Solving, Ethics, Patient Safety, Stakeholder Engagement

Industry

Biotechnology Research

Description

Job Description: We are seeking an experienced, collaborative, and strategic physician leader with deep expertise in obesity and metabolic disease clinical development to help build and execute the clinical vision for the Company’s portfolio. This role will be responsible for defining and driving clinical strategies across early- and late-stage development programs, with a particular focus on obesity, cardiometabolic, and related metabolic indications. The Senior Director, Clinical Development (MD) will play a critical leadership role in advancing innovative therapies through the clinic, combining scientific rigor, regulatory insight, and operational excellence. The ideal candidate brings a strong track record of leading obesity and metabolic clinical trials, working cross-functionally, and delivering high-quality clinical outcomes in a fast-paced biotech environment. Essential Responsibilities: Clinical Strategy & Leadership * Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development. * Provide medical and scientific leadership for clinical trial design, execution, and interpretation, including endpoint selection, patient populations, safety monitoring, and benefit–risk assessments. * Serve as the primary medical expert for obesity/metabolic programs, advising internal teams, investigators, consultants, business development partners, and investors. * Contribute to long-range clinical planning and portfolio strategy to support corporate objectives. Clinical Trial Management * Champion clinical excellence and accountability across all assigned programs. * Define clinical priorities and oversee the development of protocols, amendments, and integrated development plans tailored to obesity and metabolic indications. * Ensure delivery of high-quality clinical study outputs on time and within budget. * Oversee medical governance, ensuring ethical conduct and patient safety throughout all phases of clinical research. Regulatory & Safety Oversight * Act as the primary medical point of contact for regulatory agencies for assigned programs. * Partner closely with Regulatory Affairs, Clinical Operations, Program Management, CMC, and other functions to ensure alignment and execution. * Lead preparation, review, and contribution to key regulatory documents, including IND submissions, investigator brochures, clinical study reports, and regulatory briefing packages. * Participate in and support FDA/EMA meetings and regulatory interactions related to obesity and metabolic disease development. * Ensure compliance with GCP, ICH guidelines, and applicable regulatory requirements. Cross-Functional Collaboration * Establish and maintain strong working relationships across clinical operations, regulatory, biostatistics, translational science, safety, and commercial teams. * Provide mentorship and guidance to clinical team members, fostering a culture of scientific rigor, accountability, continuous improvement and teamwork. Stakeholder Engagement * Build and maintain relationships with key external stakeholders, including key opinion leaders in obesity and metabolic disease, investigators, consultants, and patient advocacy organizations. * Represent the Company externally at scientific meetings, advisory boards, and investigator meetings as needed. 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: * Medical Degree (MD). * Minimum 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry. * Experience leading studies for obesity or metabolic disease in the pharma industry * Minimum 5 years of leadership experience with excellent line management skills. * Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills. * A proven track-record of leading clinical trials at all stages. * Expertise in the areas of drug development, clinical operations and strategic planning. * Expertise in scientific and clinical data review and interpretation, including in-depth analysis and presentation of data from strategic perspectives * Expertise with SOPs, GCP, ICH guidelines, regulatory compliance requirements, and risk mitigation strategies. * 25%+ travel may be required. Preferred Qualifications: * Experience with FDA/EMA processes (IND filing, NDA filings). * Board certification in Endocrinology, Diabetes, Metabolism or similar discipline * Experience in operations management within a clinical research setting. * Strong leadership skills with the ability to work in a dynamic, fast-paced environment. * Excellent organizational, written and verbal communication skills with effective presentation of complex scientific data to internal and external stakeholders are essential for this role. Required Key Attributes: * Strong understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. * Attention to detail while discriminating between critical and non-critical activities and to follow established processes. * Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment. * Strong problem-solving skills and a proactive attitude towards exploring new approaches. * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism. Compensation: * This is a full-time position, Monday-Friday, occasionally 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: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) 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 technology for silencing or editing target 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. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. 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.

Responsibilities

The Executive Director will lead the development and execution of clinical strategies for obesity and metabolic disease programs, ensuring high-quality clinical study outputs. This role involves overseeing clinical trial management, regulatory oversight, and cross-functional collaboration.