Director, Clinical Science

Responsibilities

• Assist in design and implementation of clinical studies (including human pharmacology studies) and data analyses.
• Assist in reporting clinical trial data for safety and efficacy.
• Collaborate with team members to ensure Good Clinical Practices (GCPs) are followed.
• Leadership position for writing clinical and data analysis reports, slide presentations, clinicaltrial.gov summaries, etc. with other clinical development and clinical pharmacology team members, internal and external collaborators, and statistical staff.
• Contribute to clinical, scientific, and mechanism of action portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responding to information requests from regulators.
• Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders to optimize performance on clinical activities and collaborations.
• Prepare manuscripts for scientific and medical journals as well as prepare and present at scientific meetings.

Education/Experience Requirements

• PhD, PharmD, and/or MD in related Life Science discipline required; experience in rare disease and/or nephrology preferred.
• 6 years of experience in the pharmaceutical industry; equivalent combination of education and applicable job experience in academic or other setting may be considered.
• Experience working on clinical trials and clinical studies required; experience with human pharmacology studies preferred.
• Experience contributing to INDs, NDAs, BLAs, and regulatory information requests strongly preferred.

Additional Skills/Experience

• Strong organizational abilities, high attention to detail, and excellent presentation skills.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
• Demonstrated ability to review, interpret and present complex scientific data.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and outstanding verbal and written communication skills are required.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Ability to travel 15% domestically and internationally.