Senior Medical Director in Woburn, MA at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Senior Medical Director, 904052

Job Scope & Purpose:

Our client, a venture-stage biopharmaceutical company developing products for the treatment of gastrointestinal disorders, is actively recruiting a Medical Director.  This opportunity allows for a great deal of growth and leadership, and an opportunity to take an entrepreneurial approach to drug development.  This position will interact with external consultants and stakeholders in the medical community, Board members and regulatory agencies as appropriate.

Primary Job Responsibilities:

  • Hands-on involvement in the design and writing of clinical development plan including clinical documents (e.g., protocols, ICF, etc.) from first-in-human phase 1 through phase 2 and phase 3 pivotal studies that will support regulatory approval
  • Medical monitor for multiple ongoing clinical trials, including the evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity
  • Writing clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
  • Leading regular discussions with academic clinical investigators
  • Develop scientific and protocol training presentations and materials to support internal and external meetings; e.g., Advisory Board meetings, investigator meetings, and scientific meetings
  • Provide strategic leadership in the existing and planned clinical programs to support regulatory filings
  • Provide medical review, assessment, and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
  • Work closely with R&D team and consultants to assure timely filing of all clinical applications
  • Work closely with CRO Pharmacovigilance on the development of Risk Management Plans
  • Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders as needed with CMO

Primary Job Requirements:

  • M.D. or equivalent with experience in drug development, Board Certification or Board Eligibility
  • Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs.  Experience with high-complexity first-in-human studies is highly desired
  • 5 years’ experience in the biotechnology or pharmaceutical industry including direct experience leading clinical trials
  • Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations, and pharmacovigilance
  • Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities

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.
 
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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 at info@stratacuity.com or 877-787-2821.
 
Code: ClinOps

EEO Employer

Apex 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. 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.




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