Regional Vice President overseeing account management and clinical guidance for national clients at Elevance Health. Collaborating with sales and account management teams to enhance healthcare quality and outcomes.
About the role
- Executive Medical Director leading clinical development strategy for nephrology programs at Travere Therapeutics. Responsible for cross-functional leadership and regulatory interactions in rare diseases.
Responsibilities
- Lead the overall clinical development strategy for assigned program(s) as a key contributor to indication strategy, target product profile, clinical positioning, and lifecycle planning.
- Serve as the project lead for clinical programs, integrating nonclinical, translational, biomarker, safety, regulatory, and competitive insights into development plans.
- Design and oversee clinical studies across phases, including protocol concept, eligibility criteria, endpoints, safety monitoring, dose selection, and statistical considerations.
- Provide leadership for study conduct, including protocol deviation review and data interpretation.
- Lead analysis and interpretation of clinical data and author or review key documents including protocols, IBs, CSRs, abstracts, manuscripts, and health authority briefing materials.
- Partner with Biometrics to define analysis strategy and ensure clinically meaningful interpretation of efficacy, safety, PK/PD, and biomarker data.
- Serve as the project leader for assigned development program(s), driving cross-functional alignment on program goals, timelines, risks, decision points, and resource needs.
- Lead core team meetings and represent the program at governance forums, providing clear recommendations grounded in data, development risk, and strategic fit.
- Build integrated development plans in collaboration with cross-functional partners and ensure disciplined execution against milestones.
- Identify program risks early and develop mitigation strategies spanning clinical, regulatory, operational, and portfolio considerations.
- Drive scenario planning and decision analyses to support stage-gate and investment decisions.
- Contribute to global regulatory strategy and represent Clinical Development in interactions with regulatory agencies, including FDA, EMA, and other health authorities.
- Help prepare for and participate in key regulatory meetings, including end-of-Phase 2 and other milestone interactions.
- Build and maintain relationships with academic experts, investigators, patient advocacy groups, and other external stakeholders in nephrology and rare disease.
- Support due diligence and business development activities, including assessment of external assets in nephrology or adjacent rare disease areas.
- Partner closely with Clinical Operations to ensure study designs are executable and enrollment strategies are realistic for rare disease settings.
- Collaborate with Non-Clinical teams to incorporate mechanistic and disease-relevant endpoints into development programs.
- Productively interface with Clinical Pharmacology, Pharmacovigilance, CMC, HEOR, Medical Writing, and additional project functional leads not previously listed.
- Work with Medical Affairs and Commercial colleagues to align development plans with future evidence-generation needs and patient/community insights.
- Mentor junior project team members and contribute to building a high-performing clinical development organization.
- Model strong enterprise leadership, balancing program advocacy with portfolio-level thinking.
Requirements
- MD, DO, or equivalent medical degree required
- 10+ years of biotechnology and/or pharmaceutical industry experience in clinical development, with progressive leadership responsibility
- Prior experience leading clinical programs in nephrology, rare disease, or closely related therapeutic areas strongly preferred
- Demonstrated experience serving as a program or project leader in a cross-functional drug development environment
- Strong understanding of clinical trial design, dose selection, safety assessment, endpoint strategy, and interpretation of complex clinical datasets
- Experience with regulatory submissions and health authority interactions
- Track record of leading development strategy through major inflection points such as IND, proof-of-concept, end-of-Phase 2, and/or registrational planning
- Deep appreciation for the unique challenges of rare disease development, including small populations, site selection, natural history, endpoint selection, and patient engagement.
- Excellent communication and influence skills, with the ability to synthesize complex issues for senior leaders and governance bodies.
Benefits
- premium health
- financial, work-life and well-being offerings for eligible employees and dependents
- wellness and employee support programs
- life insurance
- disability
- retirement plans with employer match
- generous paid time off
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Clinical Director leading early clinical development strategy in Immunology for novel therapeutics. Collaborating across teams and executing studies to validate clinical platforms and targets.
Medical Director ensuring clinical determinations and enhancing care quality at MVP Health Care. Collaborating with teams to improve health care delivery in New York.
Medical Director responsible for clinical consultation, policy development, and quality improvement initiatives for CareSource. Must have an MD or DO and live in Massachusetts.
Medical Director overseeing administration of health services at Elevance Health. Requires extensive clinical experience and responsibilities in program management and quality improvement.
Medical Director for Elevance Health to manage healthcare services and improve clinical outcomes. Responsible for administration, strategy, and operational guidance in the healthcare sector.
Senior Clinical Development Medical Director overseeing scientific strategies for clinical trials at Novartis. Collaborating with global teams to ensure safety and oversee project deliverables.
Associate Medical Director responsible for medical content that elevates HCP education at Real Chemistry. Collaborating with cross - functional teams to drive impactful deliverables across multiple therapy areas.
Clinical Director leading a Family Health Organization in Toronto, Ontario. Guiding clinical protocols and mentoring physicians in a hybrid medical model.
Global leadership role accountable for defining and delivering the medical strategy for Radioligand Therapies at Novartis. Shaping patient access and evidence generation strategies for oncology assets in the RLT portfolio.