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Biogen

Associate Scientific Director, Clinical Pharmacology

Biogen

6d ago

No Phone Required$144k - $240kManagementUnited Stateshimalayas
Clinical-PharmacologyPharmacologyClinical-ResearchDrug-DevelopmentScientific-DirectorMid-level

Job Description

About This RoleAs the Associate Scientific Director, Clinical Pharmacology you will serve as the clinical pharmacology lead on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for doses, dosage regimens, and study designs throughout the drug development lifecycle.What You'll DoProvide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development)Provide functional representation on development program and study teamsDevelop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical)Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategiesLead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on resultsServe as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documentsSeek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as neededWork with program and/or study teams to achieve program goals and provide deliverables in approved timeframesMaintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent.Who you are:You are a scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science. You bring hands-on experience leading clinical pharmacology strategy across early and late-stage development, applying Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy. You thrive in cross-functional settings, bridging science and strategy to advance innovative therapies for patients.QualificationsPhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principlesExperience designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studiesAbility to develop Clinical Pharmacology strategy in the context of the broader development paradigmKnowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology dataExperience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SASExcellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boardsJob Level: ManagementAdditional InformationThe base compensation range for this role is: $144,000.00-$240,000.00Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:Medical, Dental, Vision, & Life insurancesFitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insuranceA minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participationWhy Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital par