Vice President, Clinical Development (Neurology)
Job Description
This is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes’s clinical development portfolio in Neurology.
Specifically, this position will have critical hands-on leadership responsibilities within the Clinical department, focused on the development of therapies for Neurology and Neuropsychology indications—including, but not limited to, sleep disorders, neuropsych, and neurodegenerative diseases.
The Vice President will drive the strategies and clinical plans across all phases of drug development. Key domains include development of study protocols, medical review of clinical trial data, and generation of clinical study reports. The Vice President will interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes, including Regulatory, Preclinical Pharmacology and Toxicology, CMC, New Product Planning, Project Management, Patient Engagement, Health Economics, Legal, Finance, Medical Affairs, and Commercial.
Responsibilities
- Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across Neurology.
- Direct authorship contributions in protocols, clinical study reports, and publications.
- Lead and develop clinical development staff and oversee hiring of additional staff as needed.
- Interact with senior management and serve as a standing member of multiple leadership meetings.
- Serve as a primary internal and external spokesperson for Alkermes Neurology clinical development programs.
- Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations.
- Partner with a cross-functional team led by Business Development to assess external assets for strategic fit, scientific merit, and clinical viability, contributing to due diligence and portfolio expansion efforts.
- Generate yearly strategic goals and objectives for the group.
- In collaboration with the clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met.
- In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required.
- Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
- Identify and develop collaborative relationships with key investigators, and key thought leaders globally. Attend and oversee clinical advisory boards and investigator meetings.
- Critically review and contribute to regulatory interactions (such as INDs and NDAs).
- Experience in overseeing the professional development and management of the clinical sciences team.
Qualifications
- Requires a MD with a Neurology background and Board Certification, alongside significant clinical and academic expertise in the field of Neurology.
- Accomplished, experienced, pharmaceutical professional with 10+ years of experience in the industry.
- A business-focused individual, with experience in all aspects of drug development, including in-licensing. A person who has built on their medical expertise and successfully applied this to enhance the development and commercialization of NCEs.
- Key strengths include focus on outcomes, ability to work in complex matrix structures, strong scientific insights, and strong communication skills with both internal and external audiences.
- Displays strong leadership and collaborative interpersonal skills.
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
- Able to work independently, prioritize tasks efficiently and meet expected time frames.
- Able to perform thorough reviews of various medical and legal documents in a timely manner.
- Excellent writing and presentation skills.
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.The annual base salary for this position ranges from $390,000 to $423,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
#LI-MB1
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.
This is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes’s clinical development portfolio in Neurology.
Specifically, this position will have critical hands-on leadership responsibilities within the Clinical department, focused on the development of therapies for Neurology and Neuropsychology indications—including, but not limited to, sleep disorders, neuropsych, and neurodegenerative diseases.
The Vice President will drive the strategies and clinical plans across all phases of drug development. Key domains include development of study protocols, medical review of clinical trial data, and generation of clinical study reports. The Vice President will interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes, including Regulatory, Preclinical Pharmacology and Toxicology, CMC, New Product Planning, Project Management, Patient Engagement, Health Economics, Legal, Finance, Medical Affairs, and Commercial.
Responsibilities
- Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across Neurology.
- Direct authorship contributions in protocols, clinical study reports, and publications.
- Lead and develop clinical development staff and oversee hiring of additional staff as needed.
- Interact with senior management and serve as a standing member of multiple leadership meetings.
- Serve as a primary internal and external spokesperson for Alkermes Neurology clinical development programs.
- Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations.
- Partner with a cross-functional team led by Business Development to assess external assets for strategic fit, scientific merit, and clinical viability, contributing to due diligence and portfolio expansion efforts.
- Generate yearly strategic goals and objectives for the group.
- In collaboration with the clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met.
- In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required.
- Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
- Identify and develop collaborative relationships with key investigators, and key thought leaders globally. Attend and oversee clinical advisory boards and investigator meetings.
- Critically review and contribute to regulatory interactions (such as INDs and NDAs).
- Experience in overseeing the professional development and management of the clinical sciences team.
Qualifications
- Requires a MD with a Neurology background and Board Certification, alongside significant clinical and academic expertise in the field of Neurology.
- Accomplished, experienced, pharmaceutical professional with 10+ years of experience in the industry.
- A business-focused individual, with experience in all aspects of drug development, including in-licensing. A person who has built on their medical expertise and successfully applied this to enhance the development and commercialization of NCEs.
- Key strengths include focus on outcomes, ability to work in complex matrix structures, strong scientific insights, and strong communication skills with both internal and external audiences.
- Displays strong leadership and collaborative interpersonal skills.
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
- Able to work independently, prioritize tasks efficiently and meet expected time frames.
- Able to perform thorough reviews of various medical and legal documents in a timely manner.
- Excellent writing and presentation skills.
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.The annual base salary for this position ranges from $390,000 to $423,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
#LI-MB1
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.
About Alkermes, Inc.
At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. With our portfolio of marketed medicines and investigational pipeline candidates, we seek to make a meaningful difference in the way people manage their diseases. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.
Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.
Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Alkermes, Inc. would like you to finish the application on their website.