Senior Clinical Development Director - Renal

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

Job summary

A leading biotechnology company is seeking a Senior Clinical Development Director to oversee global clinical programs. The role involves leading clinical deliverables, ensuring data validity, and collaborating with cross-functional teams. Ideal candidates will have extensive experience in clinical research and drug development, with strong scientific writing and data analysis skills.

Benefits

Health insurance

Retirement plans

Paid time off

Qualifications

• At least 10 years in clinical research and drug development.
• Minimum of 5 years in conducting global clinical trials.
• At least 3 years of people management experience.

Responsibilities

• Leads delivery of clinical deliverables and development strategies.
• Drives execution of clinical programs in collaboration with global functions.
• Represents the clinical section in global meetings.

Skills

Scientific writing

Data analysis

Regulatory submissions

Education

Advanced degree in life sciences or healthcare (PharmD, PhD preferred)

Job description

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Summary

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

About The Role

Major accountabilities:

• Supports or leads the delivery of clinical deliverables in the assigned section, including development strategies, protocol sections, data review, regulatory documents, and publications.
• Contributes to or leads the development of clinical sections of regulatory documents like Investigator’s Brochures and submission dossiers.
• Drives execution of clinical programs in collaboration with global functions such as clinical operations, trial leadership, 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 teams.
• Supports safety assessments, risk-benefit analysis, and safety reporting in collaboration with medical monitors and safety teams.
• Represents the clinical section in global meetings and external forums as assigned.
• Provides scientific input into development plans and standards, and may take on additional therapeutic area responsibilities.

Minimum Requirements

Work Experience:

• Advanced degree in life sciences or healthcare (PharmD, PhD preferred).
• At least 10 years in clinical research and drug development, with experience spanning Phases I-IV.
• Minimum of 5 years in conducting global clinical trials in the pharmaceutical industry, preferably in late-phase development.
• Strong scientific writing skills and experience with regulatory submissions.
• Excellent data analysis and interpretation skills, with knowledge of the therapeutic area preferred.
• At least 3 years of people management experience, including in matrix environments.

The final job title and responsibilities will depend on the candidate's experience.

Compensation and Benefits

The salary range is approximately $204,400 to $379,600 annually, with potential bonuses and stock options. Final compensation depends on various factors, including location, experience, and skills. Benefits include health insurance, retirement plans, paid time off, and others, which will be detailed upon offer.

Diversity & Inclusion

Novartis is committed to diversity and inclusion, aiming to build an equitable and representative workforce.

Why Join Novartis

Join us to help transform patient lives through innovative science in a collaborative environment. Learn more about our culture here.

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Benefits & Rewards

Discover our employee benefits here.

EEO Statement

We are Equal Opportunity Employers and do not discriminate based on legally protected statuses.

Accommodations

If you require reasonable accommodations during the application process, contact us at [email] or call [phone], including your job requisition number.