This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Vice President, Clinical Development based in the United States.
This executive leadership role is responsible for shaping and overseeing global clinical development strategy across a portfolio of rare kidney disease programs spanning all phases of development, from early clinical studies through regulatory submission and post-marketing activities. The Vice President will serve as a key clinical and scientific authority, guiding program direction within a highly matrixed, cross-functional environment and ensuring alignment between clinical strategy, regulatory expectations, and broader organizational objectives. This role acts as Global Development Physician Lead, translating complex scientific data into actionable clinical plans while ensuring programs are designed with scientific rigor and operational efficiency. The position also plays a critical external-facing role, engaging with key opinion leaders, investigators, and regulatory agencies to support development strategy and advance therapeutic innovation. It requires strong leadership in both scientific and organizational domains, with the ability to influence senior stakeholders and drive high-impact decisions. The environment is fast-paced, collaborative, and mission-driven, focused on delivering meaningful therapies for patients with rare diseases.
Accountabilities:
- Serve as Global Development Physician Lead for assigned rare kidney disease programs, overseeing clinical, scientific, and strategic direction across Phases 1–4.
- Lead the development of clinical trial protocols, study designs, and integrated clinical development strategies aligned with regulatory pathways from pre-IND through NDA/BLA submissions.
- Represent clinical development programs to executive leadership, governance bodies, and cross-functional program teams, ensuring clear communication of goals, risks, and strategic decisions.
- Partner with cross-functional stakeholders (Biometrics, Regulatory, Medical Affairs, and Safety) to develop and execute clinical development plans, timelines, and risk mitigation strategies.
- Oversee interpretation and integration of clinical data, including efficacy, safety, and benefit-risk assessments, to support regulatory filings and program decisions.
- Engage with regulatory authorities and key opinion leaders to support clinical strategy, study design alignment, and scientific discussions across development stages.
- Provide clinical and scientific input into publications, presentations, and medical communications in collaboration with Medical Affairs.
- Lead and mentor clinical development teams and consultants, fostering a high-performance, collaborative, and scientifically rigorous environment.
- Contribute to alliance and external partner engagement, ensuring alignment on clinical strategy and execution priorities.
- Support governance processes by presenting program updates, risks, and strategic recommendations to senior leadership forums.
Requirements:
- Medical degree (MD or MD/PhD required); nephrology training strongly preferred.
- 12+ years of clinical research experience within pharmaceutical or biotech environments, including design and execution of clinical trials across multiple phases.
- 8+ years of leadership experience managing cross-functional clinical development teams in a matrixed organization.
- Strong expertise in clinical development strategy, including late-stage programs and regulatory submissions (NDA/BLA experience preferred).
- Deep understanding of rare disease drug development, ideally within nephrology or metabolic/genetic disease areas.
- Proven ability to design, interpret, and communicate complex clinical and scientific data.
- Strong leadership and influencing skills with experience driving alignment across global, cross-functional teams.
- Excellent communication, presentation, and interpersonal skills, with the ability to engage both internal executives and external scientific stakeholders.
- Experience collaborating with regulatory agencies, investigators, and key opinion leaders.
- Ability to manage complexity, prioritize effectively, and adapt in a fast-changing development environment.
- Willingness to travel internationally and domestically up to approximately 25–30%.
Benefits:
- Competitive executive compensation package including base salary, annual incentive bonus, and long-term equity awards.
- Comprehensive healthcare coverage including medical, dental, and vision insurance for employees and eligible dependents.
- Retirement savings plan with employer matching contributions.
- Generous paid time off and flexible work-life balance policies.
- Life, disability, and financial protection benefits.
- Employee wellness programs and support resources.
- Opportunity to lead high-impact clinical programs in rare disease drug development.
- Strong professional development and leadership growth opportunities within a global biopharmaceutical environment.