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- Tasks: Lead clinical pharmacology projects and optimise drug dosing for CNS therapies.
- Company: Alkermes is a global biopharmaceutical company focused on neuroscience and patient care.
- Benefits: Enjoy a diverse workplace, remote work options, and recognition as a top employer.
- Why this job: Make a real impact in patients' lives while working in a collaborative and innovative environment.
- Qualifications: Ph.D. or Pharm D with 6+ years in the pharmaceutical industry; strong pharmacokinetics knowledge required.
- Other info: Join a team committed to diversity, inclusion, and mental health support.
The predicted salary is between 120000 - 168000 £ per year.
Associate Director, Clinical Pharmacology
Join to apply for the Associate Director, Clinical Pharmacology role at Alkermes
Associate Director, Clinical Pharmacology
3 months ago Be among the first 25 applicants
Join to apply for the Associate Director, Clinical Pharmacology role at Alkermes
Job Description
We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
Job Description
We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
This position will have a core scientific responsibility of selecting optimal doses and dosage regimens in patients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable.
Essential Areas of Responsibility:
- Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
- Conducting and overseeing pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modelling
- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
- Write or review clinical pharmacology components of regulatory documents and responses as well as participate directly in regulatory interactions
- Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
- Ability to function in a highly matrixed team environment
- A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills are essential in this dynamic role. Clinical pharmacology experience with small molecule in a variety of clinical investigation paradigms is desired. Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes. Knowledge of, and immediate experience in CNS therapeutics is desired.
- The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members. Upon completion of on-boarding, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams.
Basic Requirements:
- Education:Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 6+ years or 10+ years of experience in pharmaceutical industry.
Preferred Requirements:
- Demonstrated experience in serving as clinical pharmacology lead on development programs.
- PK Experience:The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
- Knowledge: Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes.
- Programming experience (e.g., NONMEN, Phoenix NLME, Monolix, R, WinNonlin, SAS, Splus etc. is desirable.
- Regulatory: Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Writing:Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (e.g.: INDs, NDAs, CTDs) is required.
- Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Seniority level
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Seniority level
Director
Employment type
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Employment type
Full-time
Job function
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Job function
Research, Analyst, and Information Technology
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Associate Director, Clinical Pharmacology employer: Alkermes
Contact Detail:
Alkermes Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Clinical Pharmacology
✨Tip Number 1
Familiarise yourself with the latest FDA regulatory guidance related to clinical pharmacology. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the CNS therapeutic area. Attend relevant conferences or webinars where you can meet industry experts and learn about current trends, which could give you an edge during discussions with the hiring team.
✨Tip Number 3
Prepare to discuss your hands-on experience with pharmacokinetic modelling and simulation tools. Being able to articulate specific examples of how you've applied these skills in past roles will showcase your expertise and suitability for the position.
✨Tip Number 4
Highlight your leadership and communication skills during any interactions with the company. Since this role involves working in a highly matrixed environment, demonstrating your ability to lead cross-functional teams will be crucial.
We think you need these skills to ace Associate Director, Clinical Pharmacology
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical pharmacology, pharmacokinetics, and any hands-on modelling experience. Use keywords from the job description to demonstrate that you meet the essential requirements.
Craft a Compelling Cover Letter: In your cover letter, express your passion for CNS therapeutics and detail how your background aligns with the responsibilities of the role. Mention specific projects or experiences that showcase your expertise in model-based approaches and regulatory interactions.
Highlight Leadership Skills: Since the role requires excellent leadership and communication skills, provide examples of past experiences where you led teams or projects. This could include managing cross-functional teams or presenting strategies to governance boards.
Showcase Relevant Publications: If you have published research or presented at conferences, mention these in your application. Highlighting your contributions to model-informed drug discovery can set you apart as a strong candidate for this position.
How to prepare for a job interview at Alkermes
✨Showcase Your Expertise
As an Associate Director in Clinical Pharmacology, it's crucial to demonstrate your deep understanding of pharmacokinetics and pharmacodynamics. Be prepared to discuss your previous experiences with quantitative modelling and simulation, and how they relate to CNS therapeutics.
✨Prepare for Technical Questions
Expect technical questions related to drug development processes, regulatory submissions, and statistical approaches. Brush up on your knowledge of FDA guidelines and be ready to explain how you've applied this knowledge in past roles.
✨Highlight Leadership Skills
This role requires strong leadership and communication skills. Prepare examples of how you've led cross-functional teams or projects, and how you’ve effectively communicated complex scientific concepts to diverse audiences.
✨Demonstrate Collaborative Spirit
Alkermes values collaboration across various departments. Be ready to discuss how you've worked in matrixed environments and contributed to multi-disciplinary project teams, showcasing your ability to foster teamwork and innovation.
