About the Role:We are building the next chapter of our clinical development portfolio and are seeking a Medical Director, Clinical Development - Immunology to help advance promising research-stage molecules toward and through early clinical development.
This is an opportunity for a Medical Director who enjoys being close to the science and the study: translating emerging biology into thoughtful clinical research strategies, designing studies that answer important development questions, and working side-by-side with colleagues across Research, Clinical Operations, Regulatory, Biostatistics, Clinical Pharmacology, Drug Safety, and other disciplines.
Your Contributions (include, but are not limited to):As a Medical Director, you will serve as a key physician and study-level clinical leader for assigned Immunology development programs. You will independently lead clinical studies while contributing your medical and scientific expertise to broader development strategy.
You will:
- Lead the design, development, and execution of Phase 1-3 clinical studies, working closely with multidisciplinary development teams.
- Develop and implement clinical study protocols and contribute to the clinical research strategy for assigned programs.
- Serve as a Sponsor Medical Monitor, providing medical oversight throughout study conduct and making study-level medical and safety decisions.
- Partner with Drug Safety colleagues to assess adverse events, evaluate emerging safety information, and support ongoing benefit-risk assessment.
- Work closely with Clinical Operations to oversee study execution in accordance with Good Clinical Practice, applicable regulations, and company procedures.
- Analyze and interpret clinical data and translate findings into clear scientific and development insights.
- Contribute to clinical study reports, investigator brochures, regulatory documents, and other materials supporting clinical development and regulatory interactions.
- Partner with Clinical Pharmacology, Biometrics, Translational Medicine, and Research colleagues to incorporate biomarkers and translational endpoints into development plans where appropriate.
- Identify and engage clinical investigators, consultants, and external experts and build productive relationships with leaders in the Immunology community.
- Bring an informed understanding of the evolving treatment landscape, standards of care, competitor activity, and emerging science to study-level development decisions.
- Collaborate across Research, Product Development, Business Development, Medical Affairs, and other functions to evaluate development opportunities and inform clinical research plans.
- Communicate study progress, emerging data, risks, and recommendations clearly to development teams and senior leaders.
Requirements:Typical Experience and Education - MD or DO degree with accredited residency training and board certification in a relevant clinical specialty for the therapeutic area required; and
- 2+ years of experience in clinical research and development (Phase 1-4) in either a pharmaceutical/biotechnology company or a clinical research/academic environment, or related experience required.
Experience That Will Help You Thrive - Clinical expertise in gastroenterology, dermatology, or another specialty relevant to immune-mediated disease.
- Experience serving as a Medical Monitor and/or Study Lead for industry-sponsored clinical trials.
- Demonstrated experience designing clinical studies and developing protocols, including selection of endpoints, eligibility criteria, dose strategy, and other key design elements.
- Experience in early clinical development, including translating preclinical or translational findings into clinical hypotheses and development plans.
- Experience working on Phase 2 or Phase 3 studies in immune-mediated diseases.
- Experience interpreting emerging efficacy, safety, biomarker, and pharmacology data to inform study-level decisions.
- Working knowledge of global drug-development requirements, Good Clinical Practice, and regulatory expectations for investigational therapies.
- Experience contributing to regulatory documents and interacting with health authorities.
- Experience engaging investigators, key external experts, CROs, and other external partners.
- Strong understanding of the competitive and evolving treatment landscape within gastroenterology, dermatology, or Immunology more broadly.
- The ability to influence and lead cross-functional teams without relying on direct reporting authority.
The annual base salary we reasonably expect to pay is $254,600.00-$347,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
