Senior Clinical Development Director - Renal

Scorpion Therapeutics; United States; Remote; USD 204,000 - 380,000; Full time

Job summary

A leading biotechnology company seeks a Senior/Clinical Development Director to oversee global clinical programs and trials. The role involves leading clinical strategies, managing teams, and ensuring compliance with regulatory standards. Candidates should possess an advanced degree and extensive experience in clinical research and drug development.

Qualifications

• At least 10 years in clinical research and drug development, including Phases I-IV.
• Minimum of 5 years in conducting global clinical trials.
• At least 3 years of people management experience.

Responsibilities

• Lead clinical deliverables in assigned sections of clinical programs.
• Develop regulatory documents and ensure data quality.
• Collaborate with global functions for clinical program execution.

Skills

Scientific writing

Data analysis

Stakeholder engagement

Education

PharmD or PhD in life sciences or healthcare

Job description

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Summary

The Senior/Clinical Development Director (Sr*CDD) is the clinical/scientific expert responsible for leading sections of a global clinical program and/or trial, such as an indication, a new formulation, or a specific development phase, under the leadership of the GPCH. The Sr* CDD may lead a team for clinical programs or global trials, depending on their size and complexity.

About The Role

Major accountabilities:

• Supports and potentially leads the delivery of clinical deliverables in assigned sections, including development strategies, protocol development, data review, regulatory documents, and publications.
• Develops and delivers clinical sections of trial and program regulatory documents like Investigator’s Brochures and submission dossiers.
• Executes the clinical program in partnership with global functions such as clinical operations, trial leaders, and data management.
• Ensures ongoing review of clinical trial data for scientific validity.
• Collaborates with data management and statistics teams for data quality and analysis.
• May manage clinical development associates or other team members.
• Supports safety assessments and safety reporting, including PSURs and DSURs, in collaboration with medical monitors and safety teams.
• Represents the clinical section in global meetings and external forums as assigned.
• Contributes to the development of disease-specific clinical standards and provides scientific input to the Clinical Development Head.

Minimum Requirements

Work Experience:

• Advanced degree in life sciences or healthcare (PharmD, PhD preferred).
• At least 10 years in clinical research and drug development, including Phases I-IV.
• Minimum of 5 years in conducting global clinical trials in a pharmaceutical setting.
• Strong scientific writing skills and experience with regulatory submissions.
• Ability to analyze scientific data and literature critically.
• Knowledge of the therapeutic area is preferred.
• Proven ability to build scientific partnerships with stakeholders.
• At least 3 years of people management experience, including in matrix organizations.

The job title and responsibilities will align with the candidate’s expertise level.

Compensation & Benefits

The salary range is estimated between $204,400 and $379,600 annually, with potential bonuses and benefits, subject to market and individual factors. Details will be provided upon offer.

Commitment to Diversity & Inclusion

Novartis values diversity and strives to create an inclusive environment reflecting the communities we serve.

Why Join Novartis

Join us to help change lives through innovative science, supported by a community of passionate professionals. Learn more about our culture.

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Benefits & Rewards

Discover our comprehensive benefits at Benefits & Rewards.

EEO Statement

We are equal opportunity employers and do not discriminate based on legally protected characteristics.

Accessibility & Accommodations

We provide reasonable accommodations for individuals with disabilities. Contact us at [email protected] or [phone] for assistance.