Executive Director, Clinical Development (Neurology)
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 in the clinical department involved in the development of therapies for neurology indications, including neurodegenerative and sleep disorders. The Executive Director will drive the strategies and clinical development 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 Executive Director 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.
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company 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 neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at .Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.Skills, Education and ExperienceRequires an MD with a Neurology background, Board Certified desired/preferred with extensive clinical and academic expertise in NeurologyAccomplished, 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 NCEsKey strengths include focus on outcomes, ability to work in complex matrix structures, strong scientific insights, and strong communication skills with both internal and external audiencesDisplays strong leadership and collaborative interpersonal skillsExperience 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#LI-MB1ResponsibilitiesPrimary 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 publicationsLead 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.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 Medical Affairs, develop, coordinate and oversee the operational aspects of Life Cycle management opportunities for marketed products 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).Full timePosting Date:
2023-11-10Estimated Salary: $20 to $28 per hour based on qualifications.
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company 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 neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at .Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.Skills, Education and ExperienceRequires an MD with a Neurology background, Board Certified desired/preferred with extensive clinical and academic expertise in NeurologyAccomplished, 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 NCEsKey strengths include focus on outcomes, ability to work in complex matrix structures, strong scientific insights, and strong communication skills with both internal and external audiencesDisplays strong leadership and collaborative interpersonal skillsExperience 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#LI-MB1ResponsibilitiesPrimary 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 publicationsLead 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.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 Medical Affairs, develop, coordinate and oversee the operational aspects of Life Cycle management opportunities for marketed products 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).Full timePosting Date:
2023-11-10Estimated Salary: $20 to $28 per hour based on qualifications.
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