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Sr. Medical Director; Clinical Development

Fore Biotherapeutics
Philadelphia, PA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Role Summary:

The Medical Director will be responsible for leading the development and execution of oncology clinical trials focused on targeted investigational new drugs. This individual will work collaboratively with the global scientific and clinical team to provide deep therapeutic area expertise and medical oversight throughout the development cycle. 


Essential Duties and Responsibilities

  • Accountable for providing medical, scientific, and strategic insights to drive the development and execution of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan, in collaboration with cross-functional team members.
  • Assume medical responsibility for clinical trials (Phase 1-3), including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and routine medical data review, including trend review and assessment for safety signals and assisting with coding and data cleaning. Conduct safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies. 
  • Design and develop clinical studies. Participate in the identification and selection of appropriate external investigators and sites.
  • Medical expert for clinical documents and contributes to the generation of investigator brochures, protocols and informed consents, and clinical study reports and regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents.
  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
  • Stays abreast of internal and external developments, trends and other dynamics, to maintain a fully current perspective of internal/external influences and/or implications for the conduct of oncology clinical trials and the assigned therapeutic area(s)
  • Develops and maintains relationships with our investigators, scientists, thought leaders and partner organizations. Interacts and facilitates relationships with external societies, advocacy groups, and alliance partner engagements. 
  • Expected to drive scientific and medical dialogue relevant to clinical programs with both internal and external collaborators. Participates in the development and implementation of project-related communications, including education of investigators, study site personnel, and study staff, advisory boards, regulatory meetings, major medical congresses, and publication of clinical study results in high quality scientific or medical journals.
  • Work in close collaboration with translational medicine to ensure alignment of translational, biomarker, and companion diagnostic development milestones with clinical trial objectives through registration. Provide clinical science development guidance regarding early development/Phase I studies or relevant acquisitions, joint ventures, or other strategic partnerships. 
  • International travel up to 20% time, based upon program needs.


Education and/or Work Experience Requirements: 

  • MD, MD/PhD (BC/BE in Oncology, Hematology, Hematology/Oncology, or related specialty) with an advanced and current understanding of cancer biology and disease processes.
  • Approximately 3 years or more of industry experience. Experienced in the conduct of clinical trials (investigator initiated, company sponsored or cooperative group trials), including designing, executing and interpreting data and their subsequent publications. 
  • Demonstrated understanding of clinical tumor biology, and the ability to apply that knowledge to drug development. 
  • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, as well as overall understanding and knowledge of NDA filing requirements. 
  • Ability to think strategically and creatively. Strong track record of enjoying the details without losing sight of the larger goals. Ability to multi-task and handle multiple projects simultaneously. 
  • Excellent technical writing, oral, presentation, and interpersonal communication skills and ability to present concepts and results in a clear and concise manner. 
  • Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.


Fore is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic

Fore Biotherapeutics

Address

Philadelphia, PA
19104 USA

Industry

Healthcare

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