Sr. Director/Vice President, Clinical Development (Immunology)

Antares Therapeutics; San Francisco (CA); Presencial; USD 350.000 - 420.000; Jornada completa

Descripción de la vacante

Antares Therapeutics 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.

This role shapes future I&I programs and operates with autonomy, reporting to the CMO as the primary physician-scientist for immunology/autoimmune programs. The role requires leading IND through Phase II/III, IND-enabling work, biomarker strategy, and external leadership with KOLs; location flexibility with

Formación

• MD/DO or equivalent with rheumatology/immunology clinical training.
• 7–10 years leading immunology/inflammation clinical development programs.
• IND-to-Phase II/III experience; IND-readiness and regulatory familiarity.

Responsabilidades

• Lead clinical development strategy from IND through Phase II/III.
• Translate mechanistic biology into development plans, including biomarker strategy.
• Lead IND-enabling/pre-IND planning with Regulatory Affairs and cross-functional teams.
• Design and oversee early clinical trials (Phase 1–3) in autoimmune diseases.
• Establish external relationships with KOLs and represent programs externally.

Conocimientos

Physician-scientist

Clinical leadership

IND readiness

Cross-functional

Biomarker strategy

Trial design

Regulatory interactions

Medical monitoring

Educación

MD/DO

Descripción del empleo

Salary Band: $350,000-$420,000

Salary Band: $350,000-$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

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 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 workstreams 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, 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/PD 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.

The anticipated annual salary range for this position is $350,000-$420,000 annually. The actual salary offered will be based on a number of factors, including but not limited to the qualifications of the applicant, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location in which the applicant lives and/or from which they will be performing the job.