Job Information
Marinus Pharmaceuticals Senior Director, Clinical Pharmacology in Randor, Pennsylvania
Marinus Pharmaceuticals, Inc Professional Remote, Remote, US Full Time 21 days ago 1243
Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders.
Headquartered in Radnor, PA, Marinus has a hybrid team of dedicated and talented professionals who value innovation, are committed to developing new therapies for patients with rare seizure disorders and are passionate about having a positive impact on our patient and local communities.
We are currently searching for an experienced professional to join our team as a
Senior Director, Clinical Pharmacology
Reporting to the Chief Medical Officer, this role will independently lead clinical pharmacology and modelling and simulation (M&S) activities to support Marinus' portfolio. This includes also having the opportunity to present clinical pharmacology plans, updates, and results to project teams and senior management.
Key responsibilities include but not limited to the following:
- Lead a comprehensive clinical pharmacology effort in support of clinical development programs.
- Responsible for leading and/or participating in Phase 1 through Phase 4 clinical study design, planning, data analysis and interpretation.
- Participate in implementing model-informed drug development using quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, special population dosing, benefit/risk assessment).
- Work closely with clinicians, statisticians, and clinical operations colleagues to design, conduct and report results of Clinical Pharmacology trials.
- Accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modelling and simulation, meta-analysis, etc.
- Able to interpret PK and PK/PD data and integrate this knowledge into the clinical trials and the overall clinical program.
- Responsible for providing the clinical pharmacology components of protocols, clinical development plans and regulatory documents.
- Influences environment outside of Marinus through methods such as publications and presentations.
Qualifications:
- Minimum of an Advance Degree (ie PhD, PharmD and MD) in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field is required
- Minimum 12 years of experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacometrics approaches, and model-informed drug discovery & development
- Strong quantitative skills and expertise (e.g. experience in population modelling, literature meta-analyses, and clinical trial simulations) with hands-on implementation of tools such as NONMEM, R, SAS, or WinBUGS for data analysis and handling.
- Ability to articulate and advocate for the use of modelling and simulation approaches to address drug development issues and questions.
- Drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in Neurology.
- Excellent communication skills, leading meetings and interacting with team members, stakeholders, and regulatory authorities.
- Knowledge of new methodologies in data sciences, artificial intelligence and machine learning is a major plus.
- Neurology experience a plus
- Up to 10% travel may be required based upon business needs
Compensation Range and Benefits:
- For this role, the anticipated base salary range: $244,000-$285,000 based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
- Marinus also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
- For additional general information on company benefits, please go to: https://marinuspharma.com/about-marinus/join-our-team/
At Marinus, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need
Search Firm Representatives Please Read Carefully
Marinus Pharmaceuticals does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
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