Sr Director Clinical Pharmacology FSHD

Waltham, MA, United States

Job Description:

Senior Director of Clinical Pharmacology

The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Company. This person will be the company’s subject matter expert (SME). This position requires an individual with experience and expertise in matrixed leadership and team management, as they will be expected to lead, develop, and educate through cross-functional teams. This individual should be able to efficiently and effectively synthesize data to produce a clinical pharmacology strategy for the programs at Company. . The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information. The person will also work very closely with team members in the bioanalytical and biomarker function. As a core member of cross-functional program teams the selected candidate will work in close collaboration with colleagues in discovery, research, clinical development, clinical operations, and project management contributing to multiple IND submissions, initiation of clinical development programs, late-stage development, and interactions with health authorities.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:

Lead the Clinical Pharmacology function and strategy, with a vision to create scientifically sound, innovative, and efficient programs that meet regulatory requirements, as well as corporate and R&D program goals, enabling advancement of Company programs across all stages of drug development.

Lead the Clinical Pharmacology accountability for Company portfolio from IND to post-approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.

Represent Translational Biomarkers SME providing expertise and guidance on PK/PD and clinical pharmacology on discovery and program teams.

integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions

Develop clinical pharmacology plans to support the development and registration of Company programs.

Be responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans.

Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission.

Lead and prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data.

Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology.

Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines.

Review external data, lead analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data.

Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.

Collaborate cross functionally with all relevant areas to support corporate objectives.

Education and Skill Requirements:

PhD, PharmD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with at least 10 years of bio/pharmaceutical industry drug development experience in Clinical Pharmacology

Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.

Demonstrated track record and ability to manage the clinical pharmacology/ pharmacokinetic components of programs in clinical stage of development.

Experienced in performing Modeling and Simulation (M&S) in drug development (i.e.. PK/PD, PBPK, mechanistic modeling, population PK)

Proficient and experienced in using common PK/PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)

Experienced in preparing Clinical Pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA submission documents.

Previous experience in antibody-drug conjugates and/or oligonucleotides is desirable.

Ability to innovate dosing strategies in a data-driven manner for this novel class of molecule.

Strong interpersonal and relationship building skills with demonstrated experience to lead and influence within a matrixed environment.

Ability to work and communicate in an open and clear manner, listening effectively and inviting responses and discussions with internal and external partners.

Must be independent and highly motivated, with the ability to multi-task, driving strategy and execution, in a fast-paced collaborative environment.

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