Sr. Director, Clinical Pharmacology

Position Overview:

As Prothena continues to advance the development of our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic/Pharmacodynamic (PK/PD) results.

The ideal candidate will work closely with the Global Project Teams to create and implement clinical pharmacology strategies to support the successful development of differentiated medications across the portfolio.  The successful candidate will lead efforts to apply state-of-the art Clinical Pharmacology and Model-Based Drug Development (MBDD) approaches to guide decision-making at the project team level across all phases of research and development including non-clinical and early-to-late stage clinical development programs. The individual must be collaborative and team-oriented and enjoy the fast-paced, multi-tasked, and hands-on research environment of a science- and patient-centric company.  Specifically, the incumbent will support the pipeline by constructing, validating, and implementing disease state, exposure-response, and additional models to evaluate risk/benefit and facilitate drug development decisions. This position will report to the SVP of Clinical Development.

Responsibilities:

The successful candidate must be able to perform each of the following satisfactorily:

• Oversee and develop Clinical Pharmacology organization to support rapidly growing portfolio of clinical assets
• Design Phase I studies and collaborate with clinical teams (e.g. Clinical Operations, Research Bioanalytical scientists, Biometrics, and Clinical Development) to select the most appropriate PK sampling strategy for Phase II-III studies
• Perform, supervise, and report PK and PK/PD analyses for Prothena assets as they progress through clinical development
• Integrate pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing for patient populations across the development continuum
• Participate in multi-disciplinary study teams (eg, scientists, biostatisticians, medical directors, and Technical Operations /Regulatory Affairs representatives) and represent the function on project teams for the timely completion of clinical studies and regulatory filings
• Contribute to protocol sections, analysis plans, study reports as well as regulatory documents (INDs, CTAs, NDAs, MAAs and Investigator's Brochure), including the preparation of standalone PK/PD reports and PK/PD/immunogenicity sections of Clinical Study Reports (CSR) and regulatory submissions
• Maintain and enhance technical and drug development expertise (e.g., training courses, external meeting attendance)
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Represent the Prothena Values in all interactions across all functions by supporting a team approach to focus on our patients and customers as our top priorities

Requirements:

Education and Experience:

• D. degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD with 12+ years of industry or equivalent experience in Clinical Pharmacology or similar background
• Strong theoretical background and hands-on experience interpreting non-clinical and clinical dose-response and PK/PD data to inform clinical study designs and drug development decision-making is required
• Proficiency with analysis software (e.g., WinNonlin, Phoenix NLME, NONMEM, or other commonly used platforms)
• Prior experience with large molecules and/or vaccine therapeutics and neuroscience is preferred
• Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting

Competencies and Attributes:

• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
• Ability to lead and work with others in a positive and collaborative manner
• Proven ability to work independently, proactively, and effectively
• Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, integrated, team-oriented setting
• Learning agility and 'scalability' to take on increasing responsibility as Prothena grows
• Understanding the legal and compliance environment
• Ability to have fun and thrive in a growing, diverse and inclusive work environment
• Strong analytical and problem-solving skills
• High competence in common software and data analysis packages (eg, SoftMax Pro, GraphPad Prism, Microsoft Office, PowerPoint, Excel, Word). Knowledge of JMP a plus

Comp Overview:

The anticipated salary range for this role is $290,000 to $400,000.  This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.  We may ultimately pay more or less than the posted range, and the range may be modified in the future.  The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the job final level offered, the type and length of experience within the job, type and length of experience within the industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

Health & Wellness Overview:

• All Prothena employees (and their families) are covered by medical, dental and vision insurance, with Prothena paying ~90% of plan premiums. 
• Prothena pays the full premium for basic life and disability insurance for all employees.  
• Prothena employees are also eligible to enroll in our Company’s 401(k) plan, and are always 100% vested in their account balances. 
• The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.
• New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays.