Senior Clinical Development Director

Title:

Company:

About reputed company:

reputed company is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At reputed company, every individual is empowered to be their true selves, grow and reputed company alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.reputed company.com/ and follow our latest news on reputed company and Instagram.

Job Description:

JOB DESCRIPTION

Position

Job Title:  Director, Clinical Development, Rare Diseases Therapeutic Area

Division / Function:   Rare Diseases Therapeutic Area (RDTA), Global R&D

Manager (Name, Job Title):   Sr Director, Odevixibat Clinical Development reputed company

Location: This is a remote role; however, if local to an R&D hub (Cambridge, MA; London, UK; Paris, FR), the candidate will have the option to come into the office as desired

Summary / purpose of the position

We are looking for a Director, Clinical Development in the Rare Diseases Therapeutic Area to join our Clinical Development team. The Medical Development Director will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases.

Main responsibilities / job expectations

Main Responsibilities

Main Tasks

Core Remit of Activities Internal to Therapeutic Area Development (approx. 75%)

• Provide medical expertise and leadership in the design and implementation of clinical development strategies reputed company with company objectives.
• reputed company the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
• Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication).
• Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data reputed company, in reputed company collaboration with the CRO medical monitor.
• Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies.
• Build and maintain strong relationships with clinical investigators and thought leaders.
• Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders.

Knowledge, abilities & experience

• Advanced scientific degree (MD [or equivalent], PhD or PharmD).
• 5+ years of clinical research and/or drug development experience reputed company the pharmaceutical industry, a CRO, or similar organization.
• Experience in designing and conducting Phase I-III clinical trials and providing medical expertise for regulatory submissions such as IND/CTA/NDA/MAA.
• Pediatric hepatology expertise preferred.

Key Technical Competencies Required

• Objective-driven, solution and results oriented, with a solid sense of urgency.
• Ability to reputed company in a fast-paced and dynamic environment.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to reputed company teams with diverse backgrounds to deliver results.
• Demonstrated ability to work cooperatively reputed company and reputed company the organization to accomplish the best outcomes for reputed company.

The annual reputed company salary range for this position is $255,000 - $306,000.

This job is eligible to participate in our short-term incentives program.

At reputed company we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. reputed company also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of reputed company pay compensation reputed company which reputed company expects to pay for this role at the time of this posting. Individual compensation reputed company this range depends on a variety of factors, including, but not limited to, prior education and experience, job-reputed company knowledge and demonstrated skills.