This is an important role within a highly visible Translational Medicine (TM) team, part of the Pharmaceutical and Early Clinical Development department. This is an opportunity to apply TM expertise and represent TM and broader early-stage clinical development interests as a key member of high performing cross-functional R&D project/program teams in neurology and psychiatry. The TM Director will have a leadership role in developing and communicating goal-driven, scientific and technologically innovative cross-functional translational strategies, proposing related clinical study designs, providing technical guidance to optimize implementation of translational assessments, and in the timely analysis of results from biomarkers, pharmacodynamic behavioral endpoints and other translational measures in clinical trials. In addition, the Director will contribute to building new, strategic translational capabilities and partnerships, ideating and evaluating new drug targets, optimizing translational relevance of preclinical research, and to business development due diligences, corporate cultural initiatives and improving R&D processes. This is an intensely collaborative role requiring proactive and cohesive integration with colleagues across all levels in research, development, clinical pharmacology, new product planning, biostatistics, project management, regulatory, legal, medical affairs, other functional areas and external partners.
Responsibilities
- Serve as TM lead for 1 or more R&D projects or programs in neurology and psychiatric disease areas
- Provide expert TM strategic and tactical leadership to teams across all stages of R&D, in interactions with senior management, and in BD due diligence activities
- Responsible for TM elements of clinical protocol design, technical excellence in implementation of TM assessments in clinical trials, rigorous analysis of TM data from clinical trials, and budget management
- Direct authorship contributions to TM strategy documents, clinical protocols, study reports, statistical analysis plans, regulatory documents, and external publications
- Contribute to strategic discussions related to TM and broader research, clinical and commercial plans, including disease area and indication analyses and prioritization
- Represent the company externally, e.g., during visits to site, vendors, advisors and in conference presentations
- Identify and develop collaborative relationships with thought leaders, investigators, and vendors
- Attend scientific advisory boards and attend and present at scientific/medical conferences
- Contribute to regulatory interactions (such as Type C and IND meetings)
Qualifications
- Ph.D., Pharm.D., M.D. or other advanced degree or equivalent experience
- Significant training and expertise in neuroscience, including a minimum of 3 years of experience in neuroscience R&D in the pharmaceutical industry
- Experience as TM representative on clinical stage programs, with responsibilities for TM strategy, implementation and data analysis
- Business-minded and familiarity with interests of stakeholders across R&D, commercial and other areas
- Exceptional oral and written communication skills and experience presenting to executive leaders
- Strong collaborative interpersonal skills and experience navigating a matrixed environment
- Ability to manage complexity, ambiguity and prioritize tasks
- Biostatistical, bioinformatic or other data science analysis skills for analyzing complex clinical data is highly desirable
- Experience with R&D technology and services vendor identification, evaluation and management
- Familiarity with regulatory requirements, interactions, reports, and submissions relevant to early-stage clinical development
- Ability to thrive in diverse, highly collaborative, cross-functional teams and to operate in a matrixed R&D environment
- Sophisticated relationship building and respectful, candid communication skills, and tactful negotiation and influencing abilities
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
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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.