EMD Serono, Inc. · 3 weeks ago
Associate Director, Clinical Pharmacology
Billerica, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$127K/yr - $206K/yr
3+ years expEMD Serono is a global leader in healthcare, life science, and electronics, dedicated to improving lives through innovative solutions. The Associate Director, Clinical Pharmacology role involves leading a cross-functional team to develop and execute quantitative pharmacology strategies for drug development, ensuring effective collaboration across various scientific disciplines to meet regulatory standards.
BiotechnologyHealth CareHealth Diagnostics
No H1B
Responsibilities
Leads and ensures that Clinical Pharmacology (CP) strategy is developed, aligned (with cross-functional development plans), endorsed and executed with studies scheduled in a cost-effective manner to support the dose selection, 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 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:
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 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 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
Qualification
Required
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
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
Benefits
Health insurance
Paid time off (PTO)
Retirement contributions
Other prequisites
Company
EMD Serono, Inc.
We aspire to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Miguel Alcalde
President of EMD Serono
Recent News
2025-12-21
Business Standard India
2025-12-20
Company data provided by crunchbase