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Moderna · 17 hours ago

Director, Clinical Pharmacology

Cambridge, MA

Full-time

Onsite

Director/Executive

$167K/yr - $301K/yr

8+ years exp

Moderna is pioneering the development of mRNA medicines to transform patients' lives. The Director of Clinical Pharmacology will lead the development of clinical pharmacology strategies, collaborate with cross-functional teams, and advocate for innovative drug development approaches.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

Responsibilities

Resonsible to develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development

Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions

Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals

Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions

Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions

Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders

Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team

Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform

Qualification

Clinical PharmacologyModel-Informed Drug DevelopmentPharmacometricsQuantitative Systems PharmacologyPK/PD principlesModelingSimulationDrug regulatory knowledgeMRNA therapeuticsData visualization softwareCommunication skillsTeamworkMentoringProblem-solving

Required

PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology

In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences

Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences

Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products

Preferred

Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred

Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams

Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc)

Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences

Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus

Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis

Ability to develop and deliver clear and concise presentations for both internal and external meetings

Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes

Strong publication record

Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams

Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential

A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative