Director of Clinical Pharmacology - Team Lead
We're representing an innovatve biotech that's dedicated to discovering and developing innovative biopharmaceutical products. With a strong commitment to transforming lives, the company focuses on specialized therapeutic areas such as neurodegenerative diseases, fertility, metabolic endocrinology, and oncology. The organization prides itself on fostering a collaborative and inclusive work environment, where scientific excellence and innovation are highly valued. Employees are encouraged to pursue continuous learning and professional development, contributing to the company's dynamic and forward-thinking culture. Job Summary: We are seeking a highly skilled and experienced Scientific Director to lead our Clinical Pharmacology team. The successful candidate will be responsible for overseeing the design, execution, and interpretation of clinical pharmacology studies, ensuring the highest standards of scientific rigor and regulatory compliance. Key Responsibilities: Lead and manage the Clinical Pharmacology team, providing scientific and strategic direction. Design and oversee clinical pharmacology studies, including first-in-human, drug-drug interaction, and special population studies. Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment of clinical pharmacology strategies with overall project goals. Develop and implement innovative clinical pharmacology approaches to support drug development programs. Ensure compliance with regulatory requirements and guidelines, including FDA, EMA, and ICH. Represent the company in interactions with regulatory agencies, key opinion leaders, and external partners. Mentor and develop team members, fostering a culture of scientific excellence and continuous improvement. Qualifications: PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or a related field. Minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry. Proven track record of leading and managing clinical pharmacology teams. Extensive knowledge of clinical pharmacology principles, regulatory requirements, and guidelines. Strong analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions. Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, cross-functional environment. Experience in interacting with regulatory agencies and presenting clinical pharmacology data. Benefits: Competitive salary and comprehensive benefits package. Opportunities for professional growth and development. Collaborative and innovative work environment.
US$225000 - US$250000 per year
Massachusetts
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MSL
Role Overview: Oversee key external experts (KEEs) by delivering scientific and medical support, with a specific focus on new product launches within hospital settings. Work collaboratively with the Medical Affairs team across various functions. Identify, evaluate, and provide ongoing support to KEEs within the designated therapeutic area, serving as the primary contact for scientific discussions. Conduct thorough research on care protocols and treatment guidelines to inform upcoming product launches. Perform extensive literature reviews and attend medical conferences, reporting on trends and observing competitive products in the market. Prepare and deliver scientific presentations to healthcare professionals, non-medical stakeholders, and patient advocacy groups. Additionally, participate in both internal and external educational activities. Represent the company at national and regional expert forums and facilitate speaker training sessions. Lead clinical initiatives in the region, including investigator-initiated trials (IITs), non-interventional studies (NIS), and registry research projects. Qualifications: A degree in medicine, life sciences, or pharmacy, with a preference for a doctoral qualification. Willingness to travel extensively, both domestically and internationally. At least 2 years of experience in a Medical Science Liaison (MSL) role. Experience in therapeutic areas such as infectious diseases, intensive care, oncology, specialty care, or hematology-oncology is highly desirable. A customer-focused and service-oriented approach, with a professional and dependable attitude. Strong knowledge of relevant regulations such as AMG, HWG, and industry compliance guidelines. Skilled in project management and delivering effective presentations. Proficiency in commonly used IT tools, with advanced PowerPoint skills. Fluency in both English and German, with excellent written and verbal communication skills.
Negotiable
Frankfurt (Oder)
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AD Clinical Pharmacology
We have a current opportunity for an AD Clinical Pharmacology on a permanent basis. This is a hybrid position (3x a week onsite) and will be based in Chicago, Illinois or South San Francisco, California. Job Type: Full-Time Department: Clinical Pharmacology Reports To: Director of Clinical Pharmacology Salary: $180,000- $253,500 Job Summary: The Associate Director of Clinical Pharmacology will lead and manage clinical pharmacology activities for drug development programs. This role involves designing and overseeing clinical pharmacology studies, analyzing data, and collaborating with cross-functional teams to support regulatory submissions and clinical development strategies. Key Responsibilities: Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s). Develop and implement clinical pharmacology strategies to support drug development programs. Collaborate with clinical, regulatory, and biostatistics teams to ensure alignment of clinical pharmacology plans with overall development strategies. Provide clinical pharmacology expertise in the preparation of regulatory documents, including INDs, NDAs, and BLAs. Analyze and interpret pharmacokinetic (PK) and pharmacodynamic (PD) data to inform dose selection and optimization. Represent clinical pharmacology in meetings with regulatory agencies and external partners. Mentor and develop junior clinical pharmacology staff. Stay current with scientific and regulatory developments in clinical pharmacology and related fields. Qualifications: PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master's Degree or equivalent education and typically 12+ years of experience, Bachelor's Degree or equivalent education and typically 14+ years of experience;(*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters) Proven track record of leading clinical pharmacology studies and contributing to regulatory submissions. Strong knowledge of pharmacokinetics, pharmacodynamics, and modeling and simulation techniques. Excellent analytical, problem-solving, and communication skills. Strategic thinking and enterprise view Ability to work effectively in a collaborative, cross-functional team environment. Experience with regulatory interactions and submissions is highly desirable. Preferred Qualifications: Familiarity with population PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin). Strong publication record in clinical pharmacology or related fields. Benefits: Competitive salary and bonus structure. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Professional development opportunities. Flexible work arrangements.
US$180000 - US$250000 per year
California
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Director of Clinical Pharmacology
We are seeking a highly experienced and motivated Director of Clinical Pharmacology to lead an Innovative clinical pharmacology team. The successful candidate will be responsible for overseeing the design, execution, and interpretation of clinical pharmacology studies, ensuring the development of safe and effective therapeutic products. Key Responsibilities: Lead and manage the clinical pharmacology team, providing strategic direction and mentorship. Design and oversee clinical pharmacology studies, including first-in-human, bioequivalence, and drug-drug interaction studies. Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment on study objectives and timelines. Interpret and present clinical pharmacology data to internal and external stakeholders, including regulatory agencies. Develop and implement innovative strategies to optimize drug development processes and improve patient outcomes. Ensure compliance with all relevant regulatory guidelines and industry standards. Stay current with advancements in clinical pharmacology and incorporate new methodologies into study designs. Qualifications: PhD or PharmD in Clinical Pharmacology, Pharmacokinetics, or a related field. Minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry. Proven track record of leading and managing clinical pharmacology teams. Extensive experience in designing and conducting clinical pharmacology studies. Strong understanding of regulatory requirements and guidelines. Excellent analytical, communication, and presentation skills. Ability to work effectively in a fast-paced, collaborative environment. Benefits: Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and innovative work environment.
US$225000 - US$250000 per year
Boston
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AD Clinical Pharmacology
We have a current opportunity for a AD Clinical Pharmacology on a permanent basis. The site locaiton is in Massachusetts. Position can be remote. For further information about this position please apply. Job Title: Associate Director, Clinical Pharmacology Salary: $180,000-$220,000 base salary, bonus, RSUs + additional benefits Company Overview: We're a dynamic and innovative pharmaceutical company dedicated to developing treatments for rare diseases and gene therapies. Our mission is to improve the lives of patients through groundbreaking research and the development of novel therapies. Position Overview: We are seeking a highly skilled and motivated Associate Director of Clinical Pharmacology to join our team. The successful candidate will play a critical role in the design, execution, and interpretation of clinical pharmacology and pharmacometrics studies, with a particular focus on rare diseases. This role requires expertise in NONMEM for pharmacokinetic and pharmacodynamic modeling. Key Responsibilities: Lead the design and implementation of clinical pharmacology studies to support drug development programs. Develop and execute pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation strategies using NONMEM. Drive development of quantitative clinical pharmacology strategy in all phases of development Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure the integration of clinical pharmacology data into overall development plans. Provide scientific and strategic input into study protocols, clinical study reports, and regulatory submissions. Interpret and communicate clinical pharmacology data to internal and external stakeholders, including regulatory agencies. Stay current with industry trends, regulatory guidelines, and scientific advancements in clinical pharmacology and rare diseases. Mentor and provide guidance to junior team members. Qualifications: PhD or PharmD in Clinical Pharmacology, Pharmaceutical Sciences, or a related field. Minimum of 5 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry. Proven experience with NONMEM for PK/PD modeling and simulation. Strong understanding of drug development processes and regulatory requirements. Excellent analytical, problem-solving, and communication skills. Ability to work collaboratively in a fast-paced, multidisciplinary environment. Experience in rare disease drug development is highly desirable. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Opportunities for professional development and career advancement. A collaborative and inclusive work environment.
US$180000 - US$220000 per year
Massachusetts
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Clinical Pharmacology and Pharmacometrics Senior Director
Senior Director of Clinical Pharmacology and Pharmacometrics Job Type: Full-Time About the Role: Are you ready to lead groundbreaking clinical pharmacology and pharmacometrics initiatives? We are on the hunt for a visionary Senior Director to spearhead our innovative team. This role is your chance to shape the future of drug development and make a lasting impact on global health. Key Responsibilities: Lead with Vision: Drive the strategic direction and execution of clinical pharmacology and pharmacometrics activities, guiding a talented team to new heights. Innovate: Develop and implement cutting-edge clinical pharmacology strategies that push the boundaries of drug development. Design and Oversee: Craft and manage pivotal clinical pharmacology studies, including first-in-human, dose-escalation, and drug-drug interaction studies. Collaborate: Work closely with cross-functional teams to integrate advanced pharmacometrics modeling and simulation into our clinical development plans. Ensure Excellence: Maintain compliance with regulatory requirements and guidelines, setting the standard for quality and precision. Represent: Be the face of the company in interactions with regulatory agencies, key opinion leaders, and external partners. Mentor: Inspire and develop team members, fostering a culture of innovation, excellence, and continuous growth. Qualifications: PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or a related field. Minimum of 10 years of experience in clinical pharmacology and pharmacometrics within the pharmaceutical or biotechnology industry. Proven track record of leading successful clinical pharmacology programs. Strong knowledge of regulatory requirements and guidelines. Exceptional leadership, communication, and interpersonal skills. Ability to thrive in a fast-paced, collaborative environment. What We Offer: Competitive Rewards: Enjoy a competitive salary and benefits package, with a base salary ranging from $260,000 to $310,000. Impactful Work: Join a passionate and innovative team dedicated to transforming healthcare. Growth Opportunities: Take advantage of career growth and development opportunities in a dynamic setting. Inclusive Culture: Be part of a collaborative and inclusive work environment where your ideas matter.
US$260000 - US$310000 per year + Medical, Dental, Vision, 401K
San Francisco
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Senior Director, Clinical Pharmacology & Pharmacometrics
Senior Director, Clinical Pharmacology & Pharmacometrics This role requires strong scientific, technical, and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical subject matter expertise as well as scientific oversight for the clinical pharmacology and pharmacometrics support of multiple programs. The Senior Director contributes to the growth of the department and will mentor or manage junior clinical pharmacologists. ESSENTIAL DUTIES AND RESPONSIBILITIES: Develop, implement, and/or supervise clinical pharmacology and pharmacometric strategies to drive programs through all stages, from research through post-marketing. Serve as the clinical pharmacology lead on multiple project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology. Advance small molecules and biologics through key development milestones, including IND/CTA, EOP2, and marketing applications. Oversee and/or conduct PK/PD and exposure-response analyses using state-of-the-art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publications. Collaborate cross-functionally with teams in Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory to achieve project and corporate objectives. Provide functional area expertise in due diligence evaluations. Drive external scientific visibility and publication objectives. Evaluate and implement innovative methods to maintain cutting-edge modeling techniques and capabilities. Ensure adherence to SHE policies, GXPs compliance, and regulatory standards within clinical pharmacology programs. Train and mentor junior staff, fostering an environment of innovation and scientific excellence. SUPERVISORY RESPONSIBILITIES: Supervise staff, including hiring, scheduling, assigning work, performance reviews, salary considerations, promotions, and other personnel decisions. Directly oversee full-time employees. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: PhD in a related discipline with a minimum of 12 years of relevant experience in the pharmaceutical industry; or an equivalent combination of education and experience. Experience - Ideal Profile for Success: At least 12 years of experience in clinical pharmacology and pharmacometrics. Experience in the development of small and/or large molecules and novel modalities. Proven track record supporting drug candidates at various stages of development within the clinical pharmacology function. Strong background in utilizing modeling and simulations to advance drug development. Experience contributing to IND/NDA/BLA and global marketing applications. Oncology therapeutic area experience preferred. Contributions to translational science and precision medicine initiatives. Knowledge/Skills: Expert-level understanding of clinical and quantitative pharmacology principles. Strong quantitative skills, including population PK models, mechanistic PK/PD models, disease models, and PBPK models. Deep knowledge of regulatory guidance related to nonclinical and clinical pharmacology for both small molecules and biologics. Excellent interpersonal, verbal, and written communication skills with the ability to convey complex technical information clearly. Strong collaboration skills with cross-functional teams. Ability to lead major projects and drive them to successful completion. Strong adaptability, problem-solving, and influencing skills in a dynamic environment. Demonstrated ability to develop strategic proposals and recommendations while motivating teams to achieve objectives. Thrives in a fast-paced business environment. Applied knowledge of GLP and GCP regulations. JOB COMPLEXITY: Operates effectively in a highly matrixed team environment. Builds collaborative networks across functions. Develops innovative solutions to complex challenges. Leads and manages high-performance teams.
US$254000 - US$360500 per year
Alameda
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Quality Assurance Specialist - Small Molecule
We are working with a leading pharmaceutical company dedicated to the development, manufacturing, and commercialization of small molecule therapeutics. Their mission is to improve patient outcomes through innovative and high-quality products. We are seeking a detail-oriented Quality Assurance Specialist to join the client on a 12 month contract, playing a critical role in ensuring that the client's small molecule products meet all regulatory and quality standards. This position involves working closely with various departments to maintain compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. Key Responsibilities: Review and approve documentation related to the manufacturing, testing, and release of small molecule products, including batch records, SOPs, and validation protocols. Ensure compliance with GMP, FDA, EMA, and other regulatory requirements, conducting internal audits and participate in external audits. Collaborate with the Quality Control team to ensure that all testing procedures are followed and that results meet quality standards. Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs) to address issues and prevent recurrence. Provide training to staff on quality-related topics and ensure that everyone is aware of and adheres to quality standards. Participate in continuous improvement initiatives to enhance quality processes and systems, identifying areas for improvement and implementing changes as needed. Conduct risk assessments and develop mitigation strategies to ensure product quality and patient safety. Qualifications: Bachelor's degree in Chemistry, Biology, Pharmacy, or a related field. Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on small molecule products. Strong understanding of GMP, FDA, EMA, and other regulatory requirements. Strong familiarity with quality management systems. Contract: Start date: ASAP 12 month contract 40 hours per week Hybrid (2 days on site) W2 only
Negotiable
Philadelphia
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Product Manager
Key Responsibilities * Perform comprehensive market analysis to identify trends, opportunities, competitive landscape, and customer requirements for digital twin technologies. * Establish and communicate a clear vision for the digital twin product line, creating a strategic product roadmap to seize market opportunities and fulfill customer needs. * Garner support for the product vision among internal teams and external stakeholders, promoting cross-functional collaboration. * Formulate pricing and positioning strategies that align with market trends and company objectives. * Convert product strategy into detailed specifications for the software development team, ensuring consistency with the product vision. * Prioritize and manage activities based on business and customer impact, overseeing the product lifecycle from concept to launch. * Work closely with engineering, marketing, sales, and senior management to deliver products swiftly and efficiently. * Lead product launches, coordinating with marketing, sales, and other departments to ensure a successful market introduction. Key Skills and Qualifications * Proven experience in product management or software development within the technology sector, ideally with exposure to the biopharmaceutical industry. * Demonstrated success in managing all aspects of a product throughout its lifecycle. * Strong capability to develop product and marketing strategies and effectively communicate recommendations to executive management. * Solid technical background, with hands-on experience in software development or a thorough understanding of digital technologies. Experience in the biopharmaceutical industry is advantageous. * Exceptional written and verbal communication skills, with the ability to explain complex concepts to a diverse audience. * MSc degree in Computer Science, Engineering, or a related field preferred. Additional Information * Maximum Salary: 80,000EUR * Starting Date: March 17th, 2025
Up to €80000 per annum
Germany
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Director of Clinical Pharmacology
Director, Clinical Pharmacology Location: New York, NY | Jersey City, NJ | California An innovative and well-funded biotech company at the forefront of drug discovery is seeking a Director of Clinical Pharmacology to join its growing Clinical Development team. This organization is built on cutting-edge scientific advancements, leveraging breakthrough technology to transform the treatment landscape for life-threatening diseases. With over $1 billion in funding, this biotech is well-positioned for long-term success and growth. Position Overview As the Director of Clinical Pharmacology, you will play a key role in building and advancing the Modeling & Simulation capabilities within the Clinical Pharmacology group. You will work on state-of-the-art quantitative techniques, including NCA, population PK/PD, disease progression modeling, physiologically-based pharmacokinetics (PBPK), and machine learning-driven pharmacometrics. This role offers high visibility within the company, strategic leadership in drug development, and the opportunity to make a significant impact on innovative therapeutics. Key Responsibilities Lead quantitative approaches to analyze preclinical and clinical data, supporting Clinical Pharmacology Project Leads. Develop and apply PK/PD models to inform dose selection, safety profiling, and regulatory submissions. Utilize modeling and simulation techniques, including population PK/PD, exposure-response, QSP, and trial simulations to drive data-driven decision-making. Design dosing regimens for First-in-Human and special populations (e.g., pediatrics) using advanced scaling techniques. Plan, execute, and report Modeling & Simulation activities independently and present findings to senior leadership and regulatory authorities. Contribute to clinical development plans by authoring key regulatory documents, including study protocols, clinical study reports, and pharmacometric analysis plans. About You Advanced degree (Ph.D., Pharm.D., or equivalent) with 10+ years of experience, or a Bachelor's degree with 12+ years of experience in Clinical Pharmacology, Pharmaceutical Sciences, or a related field. Hands-on experience with PK/PD modeling software (e.g., NONMEM, R, SAS, MATLAB, Phoenix, SimCyp, GastroPlus). Proven track record of leading pharmacometric analyses to inform critical drug development decisions. Strong analytical mindset with the ability to work independently in a fast-paced, dynamic environment. Excellent communication skills with the ability to translate complex data into strategic insights. Work Environment Hybrid role requiring a minimum of 3 days on-site in either New York, New Jersey, or California. Strong collaborative culture with direct exposure to executive leadership. Compensation & Benefits Competitive base salary: $217,000 - $237,500 (commensurate with experience). Annual bonus and equity options. Comprehensive benefits package including medical, dental, vision, 401(k) with company match, mental health support, and enhanced parental leave. Generous PTO, holiday policies, and summer/winter shutdowns. Subsidized daily lunch program when on-site. This is a rare opportunity to join a highly sought-after biotech at a pivotal growth stage. If you're looking for a strategic role with leadership potential in an environment that values innovation and scientific excellence, we'd love to hear from you.
Negotiable
New York
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Director, Pharmacometrics
'm seeking to connect with highly skilled and motivated Director of Pharmacometrics candidates to join a leading Neuroscience focused pharma company. This hands-on role will involve leading pharmacometric analyses to support multiple in-house projects. Key Responsibilities: Lead and conduct pharmacometric analyses, including population pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response modeling. Collaborate with cross-functional teams to design and implement model-based drug development strategies. Provide scientific and strategic input to clinical development plans and regulatory submissions. Communicate complex pharmacometric concepts and results to non-experts, including senior management and regulatory agencies. In-depth modeling skills, ability to translate complex problems into incisive models. Proficiency in written and verbal communication and working cross-functionally. Further develop pharmacometrics stratergies for Translational Medicine Qualifications: Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacology, Engineering, or a related field. Minimum of 7 years of hands-on modeling experience Proven track record of hands-on experience with population PK/PD modeling and simulation. Proficiency in software tools such as NONMEM, R, Monolix, or similar. Small Molecule Background (Neuroscience Experience is preferred)
US$220000 - US$260000 per year
Woodcliff Lake
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Director, Pharmacometrics
I'm seeking to connect with highly skilled and motivated Director of Pharmacometrics candidates to join a leading Neuroscience focused pharma company. This hands-on role will involve leading pharmacometric analyses to support multiple in-house projects. Key Responsibilities: Lead and conduct pharmacometric analyses, including population pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response modeling. Collaborate with cross-functional teams to design and implement model-based drug development strategies. Provide scientific and strategic input to clinical development plans and regulatory submissions. Communicate complex pharmacometric concepts and results to non-experts, including senior management and regulatory agencies. In-depth modeling skills, ability to translate complex problems into incisive models. Qualifications: Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacology, Engineering, or a related field. Minimum of 7 years of hands-on modeling experience Proven track record of hands-on experience with population PK/PD modeling and simulation. Proficiency in software tools such as NONMEM, R, Monolix, or similar. Small Molecule Background (Neuroscience Experience is preferred)
US$213000 - US$278000 per year
Woodcliff Lake
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