Senior Medical Director - Neurology in Boston, MA at APEX Systems

Date Posted: 10/19/2019

Job Snapshot

Job Description

Job #:  990803
Senior Medical Director, Neurology 990803
Job Scope & Purpose:
Our client, an established biopharmaceutical development and commercialization company focused on helping patients living with serious and rare diseases, is seeking a Senior Medical Director for their neurology-focused programs! This MD entrepreneur with expertise or experience in Neurology will help establish and lead the company through the development and commercialization of their drugs.
The Senior Medical Director, Neurology, reports to the Chief Medical Officer. The successful candidate will principally be responsible to ensure the successful design and implementation of Clinical Development Plans in the Company’s Neurology franchise from early human studies to post-marketing commitments. The Senior Medical Director, Neurology, will also provide expert advice and support to the related functions of Safety/Pharmacovigilance, Regulatory Affairs, and Medical Affairs. Finally, the Senior Medical Director, Neurology, will play an expert advisory role for other business functions and senior management.
Primary Job Responsibilities:
  • Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  • Assist in the design of clinical trials and writing/review of clinical protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, NDAs, etc.)
  • Provide ongoing medical monitoring for clinical trials including but not limited to an assessment of eligibility criteria, toxicity management, and drug safety surveillance
  • Play a key role in the development of analysis plans, and in the review, interpretation, and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials
  • Participate in and lead investigator meetings
  • Provide clinical, scientific and development expertise to business development initiatives, as needed
  • Interact with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan

Primary Job Requirements:
  • MD or DO required; meaningful training and experience in the clinical practice of Neurology.
  • Previous industry experience of at least 3 years as a study medical monitor or pharmacovigilance monitor or medical affairs role in Neurology is preferred
  • Advanced knowledge of Good Clinical Practice (GCP) for the conduct of clinical studies and associated FDA regulations for pharmacovigilance/safety reporting is required; international experience with safety reporting for foreign regulatory agencies is preferred
  • Experience with technical writing of clinical sections for FDA dossiers, study reports, clinical protocols, and SAE narratives is preferred
  • Excellent written and oral communication skills are required; good presentation skills and ability to prepare clinical data presentations is preferred
  • Strong interpersonal skills and entrepreneurial can-do attitude is essential
  • Willingness and ability to travel up to 25% of the time, including domestic and international travel

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
 
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
jprice@stratacuity.com
 
Code: ClinOps
 
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.