Vice President, Clinical Development (Neurology) jobs in United States
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Alkermes · 1 day ago

Vice President, Clinical Development (Neurology)

Alkermes is a fully-integrated, global biopharmaceutical company dedicated to developing medicines for complex psychiatric and neurological disorders. The Vice President of Clinical Development will lead the clinical development portfolio in Neurology, overseeing strategies and plans across all phases of drug development while interacting with regulatory authorities and key thought leaders.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

MD with Neurology background10+ years pharmaceutical experienceNDA submissionsApprovalsClinical development strategyProtocol designScientific insightsCollaborative interpersonal skillsLeadership skillsCommunication skillsPresentation skills

Required

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
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

Preferred

Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired

Benefits

Annual performance pay bonus
Competitive benefits package

Company

Alkermes

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Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.

H1B Sponsorship

Alkermes has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)

Funding

Current Stage
Public Company
Total Funding
$250M
Key Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO

Leadership Team

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Craig Hopkinson
EVP, Research and Development, CMO
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Company data provided by crunchbase