Director, Clinical Pharmacology
Prelude Therapeutics is a biopharmaceutical company focused on discovery and development of innovative small molecule therapeutics targeting novel pathways for the treatment of cancer and rare diseases.
Prelude is seeking a highly skilled and motivated individual with the experience and technical expertise for a newly created Director, Clinical Pharmacology to support our expanding pipeline of clinical candidates.
Join a world-class team with a passion for scientific innovation and a commitment to developing novel therapies.
Responsibilities and Duties
- Collaborate with program teams to design PK analysis plan, coordinate sample analysis and perform PK analysis for all projects
- Serve as company expert in PK/PD and Pop PK concepts, clinical studies, literature, and regulatory guidelines and conduct analyses to support development programs
- Lead Clinical Pharmacology function in collaboration with clinical, regulatory, toxicology and DMPK
- Represent clinical pharmacology function on study and project teams; develop and align strategy with program objectives
- Lead DDI risk evaluation and contribute to the design of clinical DDI evaluation strategy in collaboration with DMPK
- Contribute to design and interpretation of clinical studies, supporting clinical pharmacology objectives
- Coordinate with clinical statisticians to develop statistical analysis plans
- Communicate clinical pharmacology plans, updates, and results to project teams and senior management
- Contribute to regulatory documents and interactions; provide written and oral responses to health authority inquiries, as appropriate
- Interpret FDA, ICH regulations and GCPs, industry trends and best practices as they relate to ongoing projects
- PhD in pharmaceutical sciences, pharmacology, or related field, or PharmD with clinical pharmacology and pharmacokinetic training and experience.
- Demonstrated broad clinical pharmacology and translational development experience with knowledge in pharmacology, drug targets and core disease areas
- Strong knowledge of drug development from pre-IND through Phase 3; oncology experience preferred; experience with international drug development a plus
- Expertise using relevant PK and modeling software (e.g. WinNonlin, GastroPlus, Simcyp, NONMEM).
- Ability to work in a team matrix environment, anticipate future needs and coordinate activities with other team members
- Record of contributing to regulatory briefing documents for meetings; experience participating in health authority interactions preferable
- Comfortable managing CROs offering Clinical Pharmacology services
- Current knowledge of FDA and ICH regulations/guidance and requirements, with a demonstrated ability to apply these requirements to clinical pharmacology strategy
- Established expertise and scientific reputation through publications and/or presentations
- Effective oral, written communication, interpersonal and organizational skills
Prelude Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Job Type: Full-time
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Schedule
- Flexible Spending Account
- Health Insurance
- Life Insurance
- Paid Time Off
- Vision Insurance
All office based roles are work from home until orders are lifted by the State of Delaware. Once we return to normal operations, this position can be a combination of work from home and a few days in the office.
- Temporarily due to COVID-19