Medical Director

Company: Stratacuity: Proven Scientific Placement
Location: Lexington
Posted on: February 22, 2021

Job Description:

Senior / Medical Director, Hematology 1117854 Job Scope & Purpose: Our client is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need and they--are seeking a clinical development professional to lead the clinical development initiatives under an experienced CMO. Primary Job Responsibilities:

• Prepare the clinical development plans, in conjunction with other relevant functional areas
• Participate in the development of study protocols, statistical analysis plans, investigators brochures, and other key study documents in conjunction with other line functions and with minimal guidance
• Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
• Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate Interface with regulatory authorities as appropriate
• Act as liaison between clinical development and other internal groups for assigned studies
• Provide medical and development leadership for cross-functional teams
• Represent the company to outside medical personal in the development of clinical protocols and study conduct Primary Job Requirements:
  • MD, or DO Board certification/eligibility in hematology is highly desired
  • Minimum of 2 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs
  • Global clinical research experience and experience interacting with regulatory authorities is a plus
  • Ability to work collaboratively in a fast-paced, team-based Matrix environment
  • Ability to work independently to resolve challenges
  • Excellent oral and written communication skills-- 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. 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.-- 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 employeeservices@apexsystemsinc.com or 844-463-6178. Apex Systems dba Stratacuity, 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. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Keywords: Stratacuity: Proven Scientific Placement, Huntsville , Medical Director, Executive , Lexington, Alabama