Senior Director, Translational Medicine at Alkermes, Inc. in Waltham, Massachusetts

Job Description:

This is a high impact leadership position on the Translational Medicine (TM) team, part of the Pharmaceutical and Early Clinical Development department. It is a high visibility role that will frequently interact with leaders across functional lines in Alkermes research and development (R&D) and the broader organization. The primary role for the Senior Director, Translational Medicine is to provide expert TM opinion and direction across the organization, and to deliver and execute cohesive forward and back translational strategies that increase the probability of development success across Alkermes' pipeline of projects and programs in psychiatry and neurology. The Senior Director will champion, generate and communicate goal-driven, scientific and technologically innovative cross-functional translational strategies, propose related clinical study designs, provide technical leadership to optimize implementation of translational assessments, and deliver timely and conclusive analyses of results from biomarkers, pharmacodynamic behavioral endpoints and other translational measures in clinical trials. In addition, this individual is expected to enhance Alkermes' strategic translational capabilities and partnerships, pipeline strategy, support business development efforts and R&D processes. This is an intensely collaborative leadership 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

The successful candidate is expert in neuroscience and the landscape of central nervous system (CNS) therapeutics and has significant training and experience in neuroscience translational medicine and early clinical development. Successful experience implementing strategies for target engagement, proof-of-mechanism, patient stratification, pharmacodynamic response to treatment, disease progression and other clinical biomarker contexts of use is essential.

Deep familiarity with early-stage (Phase 1 through proof-of-concept) clinical strategy and trial design, protocol review and authoring, statistical planning, vendor and study site management, operationalizing clinical biomarkers, analyzing biomarker data, and working in alignment with regulatory guidance related to biomarkers, first-in-human clinical trials and IND, NDA and other submissions is important for success in this role.

This position also requires sophisticated skills for navigating a highly matrixed environment and an array of external R&D partners. Effective collaboration with stakeholders across internal functional lines, including clinical development, clinical operations, biostatistics, regulatory, medical affairs, discovery research and new product planning is critical. A proactive, entrepreneurial action-oriented work style and interpersonal soft skills are equally important.

This individual will need to socialize and apply biomarker expertise and data to influence and inform decision-making in project teams and executive committees, confidently and expertly communicate biomarker strategies, and interpret and present biomarker results to guide clinical development, product differentiation and reverse-translation to support discovery research.

Responsibilities

• Provide expert TM strategic and tactical leadership to teams across all stages of R&D, in interactions with senior management, and in business development due diligence activities


• Contribute to strategic R&D pipeline discussions and research, clinical and corporate plans, including disease area and indication analyses and prioritization and Alkermes' Artificial Intelligence strategy


• Create and deliver cross-functional, integrated TM biomarker strategies and early-stage clinical development plans in collaboration with project teams, leadership and external stakeholders


• Identify and develop productive, strategic partnerships with vendors, external thought leaders and investigators, and contribute to scientific and clinical advisory boards and investigator meetings


• Serve as TM lead for 2 or more R&D projects or programs in neurology and psychiatric disease areas


• Direct authorship contributions to TM strategy documents, clinical protocols, study reports, statistical analysis plans, regulatory documents (IB, IND, NDA, etc.), and external publications


• Responsible for TM elements of clinical study designs and protocols, technical excellence in biomarker operationalization, rigorous analysis of TM data from clinical trials, and budget management


• Implementation of biomarkers for target engagement, proof-of-mechanism, pharmacodynamic response, early signs of efficacy, proof-of-concept and disease progression in clinical research trials

Qualifications

• Ph.D., Pharm.D., M.D. or equivalent advanced degree in biomedical sciences


• Approximately 15 years post-graduate experience in neuroscience research and development, including several years in the pharmaceutical industry


• Deep expertise in neuroscience, CNS therapeutics, TM and clinical biomarkers


• Business-minded and familiarity with interests of stakeholders across R&D, commercial and other areas


• Experience as TM representative on clinical stage programs with responsibility for TM strategy, implementation of TM plans, TM vendor management and TM data analysis


• Demonstrated ability to successfully influence, negotiate and lead in a highly matrixed environment and with colleagues from diverse personal and professional backgrounds


• 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


• Up to date knowledge of regulatory guidance, considerations and expectations for biomarkers


• Biostatistical, bioinformatic or other data science analysis skills for analyzing complex clinical data is highly desirable


• Experience in development of companion diagnostics is a plus

  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.

  
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