Associate Director, Clinical Pharmacology

Merck KGaA•Billerica, MA

43d

About The Position

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.

Requirements

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
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

Nice To Haves

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

Responsibilities

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