Associate Director, Clinical Pharmacology

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

Associate Director, The Clinical Pharmacology (CP) Expert Team Lead (CPET-Lead) position in Quantitative Pharmacology (QP) within broader Clinical Measurement Sciences (CMS) organization will be scientific and strategic cross-functional lead role, responsible for developing and executing the QP strategies including model-informed drug development (MDD) from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Development, Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, and other colleagues within the R&D organization. The ultimate aim is to develop the right medicine with the right dosage (level, regimen and adjustments with different conditions and specific populations) and right drug combinations for ALL patients and to provide health authorities and prescribers with appropriate information.

CP Expert Team Lead is a strategic, scientific and cross-functional role, leading an Expert Team. This team comprises subject-matter-experts (SME) from CP, Pharmacometrics (PMx), clinical PK (CPK), Translational Quantitative Pharmacology (TQP), and Clinical Biomarker & Companion Diagnostics (CBD), Drug Metabolism and Pharmacokinetics (DMPK), and, on an ad-hoc basis, other functions (e.g. Chemical Preclinical Safety (CPS), Global Clinical Development (GCD), Global Clinical Operation (GCO), Global Biostatistics, Medical writing and Epidemiology (GBEM), Global Product Safety (GPS), Global Regulatory (GRA), Business franchises for life cycle management (LCM)). This role represents the CP Expert Team to the clinical team (CTT) and Global Project Team (GPT).

The CP Expert Team Lead provides strong leadership for integrating individual functional contributions, developing CP translational strategy in alignment with the overall clinical development plan, seeking the endorsement from management, and executing the program strategy/plan according to appropriate timeline.

• The approach includes, but is not limited to, translation from bench to bedside and reverse translation back to the bench, knowledge transferring from literature or external collaboration 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 LCM or an early termination with speed, efficiency and innovation based on data and model informed drug development (MIDD) approach in close collaboration with the experts on the team.
• The scope includes the internal programs from exploratory development (ED) through life cycle management, and relevant external collaboration programs of all stages related to CP discipline, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas.
  
  

As a cross-functional team leader, this role leads relevant workstreams at the CP Expert Team, as well as providing integrated team input to the GPT and leading/participating in highly interactive discussions at both levels.

Key Accountabilities

• Leads and ensures that CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed with studies scheduled in a cost-effective manner to support the indication, patient population, and phase of development while taking into account the competitive landscape
• Ensures that regular CP Expert Team meetings are held, minutes recorded, and decisions / recommendations communicated to line management and the Program Lead or Manager (PgL/PgM) or GPT
• Deliver a cross-functionally aligned FIH study and plan considering inputs from SMEs from other function lines.
• Ensure CP expert team to deliver the following with minimal supervision/guidance from line manager:
• PK/PD related assessment schedules, and the immunogenicity assessment schedule in the protocols
• The strategy for concentration-QTc evaluation and immunogenicity risk assessments
• Relevant data flow from design, to data acquisition, reconciliation, analysis, interpretation, and to the presentation to SMC, project team and governance bodies.
• PK-PD based go/no-go criteria CP related scientific aspects for the governance bodies.)
• Cross-functionally aligned input to inform dose and posology decisions, from FIH starting dose through Launch and beyond
• The delivery of fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions (DDI, food effect) and specific populations (pediatrics, geriatrics, organ impaired, ethnic populations, etc), exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines such as GBS, DMPK, GPS, GCD, GRA, etc. at appropriate stages of development
• The preparation of CP related section of major clinical and regulatory documents (clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books, etc.)
• Consistency and alignment of key content and overall flow of CP related eCTD modules (2.7.1 and 2.7.2) with other modules (1, 2 and 5) in particular Section 1.14 Labeling, 1.16 Risk Management Plan, 2.4 Nonclinical Overview, 2.5 Clinical Overview, 2.6.4 Pharmacokinetics Written Summary, 2.6.5 Pharmacokinetics Tabulated Summary and 2.7.3 Summary of Clinical Efficacy and 2.7.4 Summary of Clinical Safety
• The cross-functional responses to health authority ‘requests for information’ concerning the CP scientific areas
• In-depth CP, PK and PK/PD advice and expertise to support relevant Global Medical Affairs (GMA) studies with CP components such as dosing strategies, drug- interaction potential and exposure-response/safety analysis in close collaboration with the respective clinical functions and study teams
• Support for Experimental Medicine Phase 0 study as needed
• Involvement of Japan/China in the CP strategy
• Interacts with the leader from CMS to represent a unified view from CMS aiming at selecting right dose, right combination and right population
• May need to contribute to the in-licensing due diligence if needed
  

Expected Behaviors

• The CP Expert Team Lead has the ability to lead and operate autonomously, with minimal supervision from the line manager.
• Acts as an ambassador of QP CP expert team in the project/program team and vice versa
• Be patient centric (begin with the end in mind). Be open-minded to suggestions, strive to be innovative/creative, make data-informed decision but dare to take necessary risk when information is limited, and create a winning culture in the team
• Proactively identifies quantitative pharmacology-related issues within the project and facilitates identification of key experts needed for issue resolution and strategy definition
• Facilitates and encourages collaboration and communication within the Clinical Pharmacology Expert Team
• Identifies conflicts/dispute and actively acts to resolve them
• Ensures an efficient flow of information between the project/program team, the Clinical Pharmacology Expert Team and its represented functions
• Actively involves, aligns stakeholders and manages expectations
• Builds strong relationships with peers and cross functionally with partners outside of the Clinical Pharmacology Expert Team to enable best performance
• Learns fast, grasps the "essence" and can change course quickly where indicated
• Creates an atmosphere of commitment and team orientation toward program objectives.
• Creates a learning environment, open to suggestions and experimentation for improvement
• Embraces the ideas of others, nurtures innovation and manages innovation to reality
• Actively involves SME experts in discussion at program/GPT
• Understands the competitive landscape and the drug disposition, safety properties and exposure effect relationship properties of our competitors
• Actively collaborates with all Merck Biopharma functions within the frame of the R&D project / program
• Lives and spreads the Merck High Impact behaviours, e.g. Obsesses with Customers and Patients, Acting as the Owner, Be Curious and Innovate Boldly and Simplify and Act with Urgency etc.
  
  

Who You Are

Minimum Qualifications:

• 3-5 years (Bio)pharmaceutical industry experience with clinical pharmacology and/or hands-on pharmacometrics modeling
• Masters/Doctorate degree (PhD, PharmD or MD)/post-doctoral training relevant in the related disciplines of pharmaceutics, clinical pharmacology & pharmacometrics
• Fluency in English
  
  

Preferred Qualifications

• Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas.
• Demonstrated ability for productive collaboration in a multi-disciplinary team, using effective communication and taking personal accountability for timely delivery of results.
• Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.
• Excellent knowledge of drug discovery & development and MIDD principles
• Track record in delivering in discovery and development settings
• Excellent knowledge of work packages (non-clinical and clinical) related to PK/PD
• General knowledge of disease area, more in depth understanding of biology, pharmacology
• Strong knowledge of regulatory requirements and submission across the main regions
• Good understanding about quantitative sciences such as quantitative pharmacology, safety and biomarkers
• General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus
  
  

Pay Range for this position: $126,900 - 205,800

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites. For more information click here.

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