Director, Clinical Pharmacology (Remote)

Director, Clinical Pharmacology (Remote)

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Windsor CO
Windsor, CO 80550, USA

Purpose and Scope

The Clinical Pharmacologist will promote clinical pharmacology strategies, inclusive of the pharmacokinetics/pharmacodynamics and principles of model-based drug development across all stages of drug development.

This role will be accountable for supporting development projects by defining the early & late clinical and regulatory program, working closely with cross-functional colleagues to support regulatory submissions proprietary products .

In this role, the Clinical Pharmacologist will provide guidance in pharmacokinetics and biostatistics to the Tolmar clinical and non-clinical development staff.

• Provide expert scientific and strategic drug development insight to R&D and all levels of management on critical decisions and development plans for multiple projects across multiple therapeutic areas.
• Provide leadership and develops strategic drug development recommendations to project leads.
• Leads teams or sub-teams within the clinical department and across functions as assigned.

  May be assigned leadership role for cross-functional project teams.

• Develops, authors, and/or reviews clinical protocols, reports, and regulatory filings (pre-IND through NDA).

  Anticipates regulatory questions and prepares the organization for response.

• Understand PK/PD regulatory advances, strengths, weaknesses, opportunities, and threats to assist with responses and appropriate PK/ statistical strategies.
• Independently leads PK/PD activities and multiple self-initiated projects.
• Assists R&D senior management in selecting aggressive action plans that best meets clinical pharmacology, regulatory and drug development business objectives.
• May directly provide the generation, analyses, interpretations and reporting of clinical and non-clinical PK data.

  Leads development of modeling and simulation.

  Provide primary PK support on studies and investigates, identifies, develops, and optimizes new PK/PD models and in-vitro/in vivo correlations (IV/IVC).

• Coordinate with clinical CROs to develop and execute work orders for PK sample analysis; effectively track and ensure PK sample analysis are conducted in a timely and quality manner to meet program milestones.
• Responsible for oversight of bioanalytical method development and validation as appropriate.
• Work with statistical support vendors in development projects, perform and/or review standard sample size calculations.
• Develop, review and/or maintain Standard Operating Procedures and Work Instructions for Tolmar related to PK and statistical analysis.
• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time results within the clinical group.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities  

• Current knowledge of FDA and ICH regulations/guidance and requirements, with a demonstrated ability to apply these requirements to clinical pharmacology strategy
• Expert knowledge of clinical and non-clinical experimental design, including PK analysis of in vivo and in vitro studies.
• Expertise in interpreting and presenting clinical PK findings and providing solutions for issues impacting clinical development objectives.
• Solid problem-solving skills, conflict resolution and providing innovative solutions.
• Proficient computer skills and experience working with WinNonLin programs, Microsoft Office and other appropriate software platforms as required.
• Experience working in multifunctional teams and independently as well contribute to a learning environment.
• Ability to anticipate future needs and coordinate activities with team members. 
• Strong interpersonal skills and ability to build strong relationships with peers.
• Established expertise and scientific reputation through publications and/or presentations.
• Practical and efficient communication skills.
• Strong organization, time management and resource planning skillset.
• Record of contributing to regulatory documents including briefing packages and eCTD modules; demonstrated experience participating in health authority interactions.

Core Values

• The Director, Clinical Pharmacology is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Ph.D.

  in pharmaceutical sciences, pharmacology, or PharmD with a minimum of 8 years of clinical pharmacology and pharmacokinetic experience.

• Demonstrated ability to lead PK/PD, Biopharmaceutics and Pharmacometrics activities cross-functionally from planning, implementation and completion.
• Strong knowledge of drug development from pre-IND through Phase 3; direct experience with 505(b)2 development required; experience with international drug development a plus.
• Quantitative skills and/or management experience in conducting population modeling, literature meta-analyses, and/or clinical trial simulations utilizing common tools (e.g., NONMEM, R).

  Hands-on or management experience with PK/PD and PBPK software packages such as Phoenix WinNonlin, SimCYP, Gastroplus, SimBiology a plus.

• Benefits information:

  Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

  The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

41 CFR 60-1.35(c)