Associate Medical Director, Clinical Development at Tonix Pharmaceuticals

Berkeley Heights, NJFull-timeClinicalPosted about 2 months ago

About the Role

<div class="content-intro"><div> Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit <a href="https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9p5FBvlzG2u-9NzVEDdUgRNdl57Mw08p4h9XviYYnbwVJ-X_DNEOeN4RdGA64IhTnk9R4lQWNXhq0g8TrvoRTCZSpqmowBapMZCbqP_sxm0%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987080441%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WrmW8ZuY9XRYJZM0BMPu3thoab5uVHnt9SqBNHIoDuU%3D&reserved=0" data-auth="NotApplicable" data-linkindex="11">www.tonixpharma.com</a> and follow the Company on <a href="https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbldblPUeLBo2VtrimIDsthVk4RaPH1sCjnDw18J2Q9UGKOYpi7kKsd6NuJ4rb7a1ocGevguAt4l_8t8TE5rfCP1YmSBTJO1HR9Uo9KAv_DEwtbEkJhm1CdLRAEbAUNB-&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987109283%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dHRzyv5dfKFOhCroh809txjNcJOjNrBSQRyfSgHaIu8%3D&reserved=0" data-auth="NotApplicable" data-linkindex="12">LinkedIn</a> and <a href="https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D0NgIEJjy96AytWlfgCqgqVv5cOeUVkGOTFS78koSy22XXOczOtXjxSorNUcN-uDTk4CYVQkJndgCk6o2RQBlKQ%3D%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987130654%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=frLcoK5ETOWzJq9lmvkirCS8HaHc2WCX%2Fg4ESMSdLgk%3D&reserved=0" data-auth="NotApplicable" data-linkindex="13">X</a>. </div> <div> *Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. </div> <div> Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners. </div></div>Position Overview The Associate Medical Director, Clinical Development will play a key role in advancing clinical programs by contributing to clinical strategy, study design and execution, data interpretation, and development of clinical and regulatory documents. Working cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, and other teams, this individual will help translate scientific insights into strong clinical evidence and meaningful program decisions. This individual contributor role offers significant ownership and the opportunity to influence clinical development strategy while working closely with cross-functional leaders. Essential Functions <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Provide scientific leadership for and contribute to the clinical development strategy and plans for vaccine and prophylactic monoclonal antibody candidates from early-stage development through later-stage clinical studies.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Lead and support the design, implementation, execution, and interpretation of Phase 1–3 clinical trials, as applicable.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Author clinical study protocols, protocol amendments, informed consent materials, clinical study reports, investigator brochures, statistical analysis plans, and other clinical and regulatory documents.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Provide scientific input into study objectives, endpoints, eligibility criteria, schedules of assessments, immunogenicity evaluations, and exploratory biomarker strategies.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Review emerging clinical data to evaluate safety, tolerability, immunogenicity, efficacy, and overall benefit-risk.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Lead ongoing medical and scientific data review, including review of listings, tables, figures, laboratory results, adverse events, protocol deviations, and other clinical trial data.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Partner closely with Biostatistics and Data Management on data analysis, interpretation, and presentation.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Work with Clinical Operations to support high-quality study execution, including investigator and site engagement, study training, enrollment strategies, and resolution of scientific or clinical study issues.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Conduct field assessments of clinical trial progress, including travel to investigative sites and endemic areas, as needed, to evaluate study execution, patient populations, and enrollment of appropriate high-risk populations.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Collaborate with laboratory partners on immunologic assays and interpretation of humoral and cellular immune-response data, as appropriate to the program.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Contribute to regulatory submissions and interactions with regulatory authorities, including briefing documents, responses to information requests, and clinical sections of INDs/BLAs or other applicable submissions.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Support preparation of abstracts, posters, presentations, manuscripts, and other scientific communications describing clinical program results.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Monitor relevant scientific literature, competitive programs, regulatory guidance, epidemiology, and advances in vaccinology and infectious diseases.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Develop effective relationships with investigators, key opinion leaders, external experts, CROs, laboratories, and other development partners.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Contribute to cross-functional program and study teams and communicate clinical findings, risks, and recommendations clearly to internal stakeholders.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Serve as a clinical development scientific lead for assigned studies or programs, integrating clinical, operational, statistical, safety, and regulatory perspectives to support program-level decision-making.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Maintain high standards of scientific rigor, data integrity, GCP compliance, and patient safety.</li> </ul> Necessary Skills and Abilities <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Strong scientific foundation in vaccinology, immunology, infectious diseases, or a related scientific or medical discipline.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Ability to critically analyze complex clinical and scientific datasets and translate findings into clear conclusions and recommendations.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Excellent organizational skills with the ability to manage multiple priorities and deliver high-quality work within timelines.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Strong interpersonal and collaboration skills, with the ability to work effectively across scientific, clinical, operational, and regulatory functions.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Comfortable operating in a fast-paced biopharmaceutical environment, with the ability to roll up your sleeves, work hands-on, and adapt as priorities evolve</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">High attention to detail, intellectual curiosity, sound scientific judgment, and commitment to patients and rigorous clinical research.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Willingness and ability to travel up to 20% to clinical trial sites and endemic areas to assess study progress, engage with investigators and site teams, and provide clinical and scientific insight to support enrollment of appropriate high-risk patient populations.</li> </ul> Educational Requirements <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">PhD, PharmD, MD, or equivalent advanced degree in a relevant scientific or medical discipline required. MD preferred but not required.</li> </ul> Experience Requirements <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">5+ years of relevant clinical development experience within the biotechnology or pharmaceutical industry.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Demonstrated clinical development experience, including direct experience supporting vaccine clinical development.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience leading and providing scientific oversight for clinical trials, including study design, execution, data review, and interpretation.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Strong understanding of clinical endpoints, statistical concepts, and benefit-risk assessment, with experience applying these principles to large clinical trials.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience with vaccine, infectious disease, and/or prophylactic monoclonal antibody clinical development preferred.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience reviewing and interpreting clinical datasets and contributing to clinical protocols, study reports, regulatory documents, publications, or presentations.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Strong understanding of clinical trial methodology, GCP, and the drug/biologic development process.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience working on cross-functional clinical development teams.</li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Familiarity with immunogenicity assessments, including antibody and/or cellular immune-response measurements, preferred.</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary Range</div><div class="pay-range">$180,000—$240,000 USD</div></div></div><div class="content-conclusion">*Please note that Tonix does not offer sponsorship for this role. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Tonix provides a comprehensive compensation and benefits package which includes: <ul type="disc"> <li style="font-size: 12pt;">Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs</li> <li style="font-size: 12pt;">Pet Insurance</li> <li style="font-size: 12pt;">Retirement Savings 401k with company match and annual discretionary stock options</li> <li style="font-size: 12pt;">Generous Paid Time Off, Sick Time, & Paid Holidays</li> <li style="font-size: 12pt;">Career Development and Training</li> </ul> Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law.  In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment.  This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.  Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.</div>

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