Sr. Director/Vice President, Clinical Development; Immunology) San Francisco, CA
Listed on 2026-10-07
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Doctor/Physician
Internal Medicine Physician
Salary Band: $35 0,000-$420,000
Location: Boston, MA or San Francisco, CA
The Opportunity
Antares is seeking a Sr. Director or Vice President, Clinical Development to serve as the hands‑on physician‑scientist clinical lead for our lead Immunology/inflammation program and to help shape subsequent programs in our 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.
This 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 our CMO and will be the primary physician‑scientist supporting immunology/autoimmune disease programs.
Key Responsibilities
- 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 PoM/PoC 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 and content, including:
- clinical sections of the IND
- Investigator’s Brochure input and review
- clinical trial protocols
- clinical sections in global regulatory documents
Early Clinical Trial Design & Execution
- Design and oversee early clinical trials (e.g., Phase 1 healthy volunteer studies, Phase 1b/2a PoC 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 Ops to ensure high‑quality execution: site strategy, enrollment assumptions, timeline realism, and vendor/CRO oversight.
- Serve as medical monitor for I&I clinical trials.
Scientific & External Leadership
- Establish and maintain relationships with key external experts and KOLs 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 (when appropriate) 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 work streams rather than managing large teams.
- Provide hands‑on guidance to matrix team members and influence without heavy reliance on direct reporting structures.
Ideal Candidate Profile
Required
- Medical degree (MD, DO, or equivalent), clinical 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,…
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