Executive Director – Pharmacometrics Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
1) As a line manager, the Executive Director is responsible for:
- line leadership and management of Pharmacometrics and those assigned as Quantitative Pharmacology Leads (QPL)
- coaching and developing pharmacometrics skills and infrastructure
- developing appropriate capabilities and Infrastructure as it pertains utilization of predictive modeling approaches
- establishing and maintaining appropriate quality systems in the functional area
- resourcing, recruitment, supervision, training and staff development
2) As a manager, the Executive Director is responsible for:
- assignment of appropriate pharmacometric representation on drug development and clinical teams and provision of such expertise and leadership to a project,
- Pharmacometric deliverables for the assigned projects in the sphere of influence either directly or via pharmacometricians or by utilizing best practices,
- planning and direction of pharmacometric components: of clinical programs (including clinical development plan/life cycle plan) and studies (including protocol preparation, study reporting, interpretation)
- during the pre-POC clinical stages, collaborate with colleagues in other groups responsible for pre-POC work to have a suitable end-to-end translational and pharmacometric (Model based) development strategy with appropriate quantitative decision criteria enabling POC.
- Enabling appropriate dose-finding strategies through QPL’s during clinical drug development that will ensure optimal doses and dosage regimens in patients
- appropriate design and implementation of a clinical modeling and simulation plan that conforms to our best practices,
- Enable a consistent access to data process
- consistent and high quality work products in:
- use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout the drug discovery and development lifecycle,
- appropriate summarization and interpretation of results of pharmacokinetic/ pharmacodynamic analyses with respect to their impact on development and clinical use of drugs,
- pharmacometric support and leadership for the preparation of regulatory documents (Summary of Clinical Pharmacology and Summary of Biopharmaceutics) and defense of NDA/MAA/BLA
- Clear understanding of pipeline efforts
3) Beyond, the Executive Director provides:
Leadership within Quantitative Pharmacology & Pharmacometrics and larger PPDM organization via initiatives, committees, development of best practices and mentoring.
Leadership within Merck via appropriate committees, initiatives, etc.
Influence outside of Merck through publications, presentations and involvement in professional organizations.
Provides line leadership and management towards enabling predictive model based approaches (Pharmacometrics):
Responsible for resourcing, recruitment, supervising, training, motivating and developing colleagues in activities described below as well as conducting such activities.
Provides strategic leadership for pharmacometrics.
Collaborates with colleagues to develop best practices; leads some process/scientific initiatives as needed.
Ensures compliance. Stays abreast of literature, internal SOPs, regulatory agency guidelines, including Good Clinical Practice, and other relevant regulations in order to provide appropriate “state of the art” support to teams.
Participate in multidisciplinary teams in assessing potential in-licensing opportunities.
Produces and presents quality scientific papers at external meetings and for publication.
Manages and initiates external collaborations with world leading experts to develop new methodologies.
Develop and sustain a strong training curriculum
Develop and sustain a state of art pharmacometric and quality infrastructure
when resourced, are responsible for providing the translational (PK/PD) components of non-clinical plans and provide such expertise to the project team
appropriate use of meta-analysis approaches towards understanding drug and product attributes
responsible for providing the pharmacometric components of clinical plans and provide such expertise to the project team.
Strategic understanding of the overall clinical development plan and work closely with leadership and QPLs to continually update and refine plan.
Appropriate planning, design and analysis of data from studies that relate to the model based studies; accountable and responsible for assigned protocol and study report content.
Coordinate within the leadership team the appropriate balance of internal and external resourcing strategies in the design, analysis and reporting medical writers (and other team members) in the data review, analysis and reporting of the clinical pharmacology study.
Is accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc. Direct the planning of relevant PK-PD analyses.
Appropriate use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with matrixed areas.
Recommendations for clinical doses and dosing algorithms (including drug interaction advice, advice for concomitant administration with food, special population dosing, etc.) to the clinical and development teams and in regulatory documentation such as labeling are based on high quality work.
As appropriate, co-lead contributions with key stakeholders in all regulatory documents including Investigator’s Brochures, End of Phase 2 meetings, NDA/MAA/BLA, and post-approval filings.
- Ph.D., or equivalent training with minimum of 15 years of clinical drug development experience;
- M.S degree would need to demonstrate commensurate accomplishments.
- Demonstrated expertise in the use of model-based approaches integrating pharmacokinetics, pharmacodynamics and clinical pharmacology, and application to preclinical and clinical drug development.
- Demonstrated leadership and management experience in pharmacometrics and/or clinical pharmacology, drug development or regulation.
- Experience in interactions with regulatory agencies is very desirable specially with demonstration of successful pharmacometric strategies
- Experience in developing quantitative drug development strategies is required
- A track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations
- Clinical pharmacology &Pharmacometrics: demonstrates the following: 1) understanding the principles of PK, PK-PD, and pharmacology relevant to drug candidates; 2) through understanding of modeling and simulation based on PK and PK-PD and associated statistical principles; 3) knowledge of trial design including design and interpretation; and 4) other relevant scientific disciplines, including statistics, drug metabolism/transport, biopharmaceutics, pathophysiology and therapeutics.
- Communication Skills: demonstrates ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form steer and influence interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
- Scientific Excellence: demonstrates understanding of the complexities and recent developments in clinical pharmacology and pharmacometrics including implications for drug development.
- Regulatory Knowledge: understands and is able to apply appropriate FDA, EMA and other/ICH guidelines in the application of predictive model based approaches in the design of development plans and study designs.
- Networking and Alliance Building: good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of development objectives.
- Big Picture/Strategic Thinking: ability to demonstrate a broad perspective on the overall compound development and how the functional area contributes; ability to understand stakeholder needs.
- Innovation: constantly looking for new approaches and able to devise/apply new techniques
- Courage with Decisiveness to Act: bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to the development of drug candidates.
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Job: Quantitative Sciences Generic
Job Title:Exec. Dir, Quant. Sciences
Primary Location: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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