Director Of Clinical Pharmacology

EMD Millipore Billerica , MA 01821

Posted 2 months ago

Your role:

You will be serving a dual-role of the Clinical Pharmacology Expert Team Lead (CPET-L) and the Clinical Pharmacology (CP) expert. CPET-L is a strategic, scientific and cross-functional role, leading an expert team which comprises subject matter-experts from CP, Pharmacometrics, Translational Modeling & Simulation, Clinical Biomarker, Drug Metabolism and Pharmacokinetics, and, on an ad-hoc basis, other global functions. This role represents the CP Expert Team to the global project team.

As a scientific and strategic leader, CPET-L provides strong leadership for integrating individual functional contributions, driving the model-informed drug discovery and development (MID3), developing CP translational strategy in alignment with the overall clinical development plan, aligning with the stakeholders, and executing the program strategy/plan according to appropriate timeline.

  • The approach includes, but is not limited to, quantitative translation from bench to bedside and reverse translation back to the bench, knowledge integration from literature or external data to internal programs, with regarding to pharmacokinetics, pharmacodynamics, disease progression, relevant covariates (such as baseline disease, target, and pathway) and posology/dosage aiming to move the program to the next stage leading to regulatory submissions and life cycle management or an early termination with speed, efficiency and innovation based on data and MID3 approach in close collaboration with the experts on the team.

  • The scope includes the internal programs from exploratory development through life cycle management, and relevant external collaboration programs of all stages related to quantitative pharmacology discipline, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas with emphasis on oncology, immuno-oncology, neurology and immunology.

As a cross-functional team leader, this role leads relevant workstreams at the CP Expert Team, is accountable for providing integrated team input to the GPT and leading/participating in highly interactive discussions at both levels. This role requires a sense of urgency with a strong can-do attitude in identifying and driving the debate around key issues while keeping the big picture and long-term targets in mind. Therefore, it is vital for this individual to have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities. CPET-L is responsible for establishing the processes for team collaboration and providing feedback on performance of individual team members with a goal of creating a winning team culture.

CPET-L will also act as the CP expert on the team. As a CP expert, you will support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the targeted population, applying principles of MID3.

Who you are:

Minimum qualifications:

  • Bachelor's degree with 10 plus years of experience, master's degree with 5 plus years of experience, or PhD with 3 plus years of experience is required.

Preferred qualifications:

  • PhD or MD in related sciences or equivalent training in clinical pharmacology, PK/PD sciences, pharmacometrics or allied disciplines preferred.

  • Direct industrial experience of 7 plus years of experience is strongly preferred.

  • Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas, and application of mechanism-based population PK/PD modeling and simulation.

  • Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.

  • Track record in delivering in discovery and development settings.

  • General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus.

  • Excellent knowledge of regulatory requirements and submission across the main regions.

  • Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment

  • Outstanding presentation, communication and organization skills; ability to lead, influence, and motivate others.

Job Requisition ID: 203884

Location: Billerica

Career Level: E - Professional (10+ years)

Working time model: full-time

US Disclosure

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Boston

Job Segment: Manager, Pharmacology, Neurology, Clinic, Immunology, Management, Healthcare


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As a scientific and strategic leader, CPET-L provides strong leadership for integrating individual functional contributions, driving the model-informed drug discovery and development (MID3), developing CP translational strategy in alignment with the overall clinical development plan, aligning with the stakeholders, and executing the program strategy/plan according to appropriate timeline. * The approach includes, but is not limited to, quantitative translation from bench to bedside and reverse translation back to the bench, knowledge integration from literature or external data to internal programs, with regarding to pharmacokinetics, pharmacodynamics, disease progression, relevant covariates (such as baseline disease, target, and pathway) and posology/dosage aiming to move the program to the next stage leading to regulatory submissions and life cycle management or an early termination with speed, efficiency and innovation based on data and MID3 approach in close collaboration with the experts on the team. * The scope includes the internal programs from exploratory development through life cycle management, and relevant external collaboration programs of all stages related to quantitative pharmacology discipline, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas with emphasis on oncology, immuno-oncology, neurology and immunology. As a cross-functional team leader, this role leads relevant workstreams at the CP Expert Team, is accountable for providing integrated team input to the GPT and leading/participating in highly interactive discussions at both levels. This role requires a sense of urgency with a strong can-do attitude in identifying and driving the debate around key issues while keeping the big picture and long-term targets in mind. Therefore, it is vital for this individual to have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities. CPET-L is responsible for establishing the processes for team collaboration and providing feedback on performance of individual team members with a goal of creating a winning team culture. CPET-L will also act as the CP expert on the team. As a CP expert, you will support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the targeted population, applying principles of MID3. Who you are: Minimum qualifications: * Bachelor's degree with 10 plus years of experience, master's degree with 5 plus years of experience, or PhD with 3 plus years of experience is required. Preferred qualifications: * PhD or MD in related sciences or equivalent training in clinical pharmacology, PK/PD sciences, pharmacometrics or allied disciplines preferred. * Direct industrial experience of 7 plus years of experience is strongly preferred. * Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas, and application of mechanism-based population PK/PD modeling and simulation. * Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc. * Track record in delivering in discovery and development settings. * General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus. * Excellent knowledge of regulatory requirements and submission across the main regions. * Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment * Outstanding presentation, communication and organization skills; ability to lead, influence, and motivate others. 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Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday. Merck Kgaa Billerica MA

Director Of Clinical Pharmacology

EMD Millipore