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Salary: USD 350,000 - 420,000 / annual
Antares Therapeutics is seeking a Senior Director or Vice President of Clinical Development to serve as the hands-on physician-scientist clinical lead for the company's lead Immunology/Inflammation program and to help shape subsequent programs in the growing I&I portfolio. This is a rare opportunity to architect clinical strategy from the ground up, partnering closely with cross-functional leaders to bring a novel program through IND and into early clinical development and ultimately late-stage development.
The role is intentionally designed for an individual who thrives in a builder environment—someone who wants to be close to the science, own key decisions, and operate with significant autonomy. The role reports directly to the Chief Medical Officer and will be the primary physician-scientist supporting immunology/autoimmune disease programs.
Key responsibilities include:
**Program & Portfolio Clinical Leadership**: Serve as the clinical development lead for Antares' lead Immunology/Inflammation program and contribute to long-term strategy for future I&I programs. Develop and own the clinical development strategy from IND through Phase II/III, including indication sequencing, target product profile (TPP), and key value inflection points. Translate mechanistic biology into clinically actionable development plans, including biomarker strategy and proof-of-mechanism/proof-of-concept endpoints.
**Pre-IND and IND Readiness**: Lead clinical input into IND-enabling and pre-IND planning, partnering closely with Regulatory Affairs, Translational Medicine, Nonclinical, CMC, and Clinical Operations. Drive preparation of key clinical/regulatory documents including clinical sections of the IND, Investigator's Brochure input and review, clinical trial protocols, and clinical sections in global regulatory documents.
**Early Clinical Trial Design & Execution**: Design and oversee early clinical trials (Phase 1 healthy volunteer studies, Phase 1b/2a proof-of-concept, and Phase 3 registrational trials), ensuring scientific rigor and feasibility in autoimmune populations. Own endpoint strategy, patient selection/enrichment concepts, dose/regimen rationale, and decision criteria for go/no-go milestones. Partner with Clinical Operations to ensure high-quality execution. Serve as medical monitor for I&I clinical trials.
**Scientific & External Leadership**: Establish and maintain relationships with key external experts and key opinion leaders across autoimmune disease areas, including advisory boards and scientific forums. Serve as a key external-facing presence for Antares' I&I programs. Partner closely with internal leadership to shape the clinical narrative for internal governance, board-level updates, and external communications.
**Cross-Functional Leadership in a Lean Environment**: Operate as a highly collaborative, high-ownership leader in a lean structure; contribute directly to critical workstreams rather than managing large teams. Provide hands-on guidance to matrix team members and influence without heavy reliance on direct reporting structures.
**Requirements**
Required:
- Medical degree (MD, DO, or equivalent), clinically trained as a rheumatologist, immunologist, or equivalent specialty with significant scientific depth and demonstrated ability to operate as a physician-scientist in drug development.
- 7–10 years of industry experience leading clinical development programs in Immunology/Inflammation and/or autoimmune diseases, with demonstrated expertise in at least one of the following disease areas: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, inflammatory bowel disease (Crohn's/ulcerative colitis), Sjögren's disease, systemic sclerosis, dermatomyositis, lichen planus, or closely adjacent immune-mediated disorders.
- Demonstrated success advancing programs from IND through Phase II and/or Phase III (approval experience a major plus but not required).
- Hands-on experience designing and executing early clinical trials, including early phase strategy (Phase 1 SAD/MAD or equivalent), biomarker/pharmacodynamic integration into clinical plans, trial design, endpoint selection, and interpretation of early efficacy signals.
- Strong understanding of clinical development fundamentals: regulatory interactions, safety monitoring, protocol development, and cross-functional program leadership.
- Ability to work with urgency and clarity in a high-accountability environment.
- Ability to collaborate well with others, have a growth mindset, and acknowledge one's limitations.
Strongly Preferred:
- MD/PhD training background (or equivalent sustained scientific depth and translational credibility).
- Combination of large pharma and biotech experience.
- I&I development experience in both pharma and biotech settings.
- Experience in mechanisms related to immune pathways, innate immunity signaling, transcriptional regulation, and/or cytokine pathway biology.
