Senior Medical Director - Oncology

Location Washington, D.C.
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Salary: $280,000 - $320,000 Per annum
Contact name: Stuart Gilboy

Contact email: stuart.gilboy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 20768
Published: 29 days ago
Expiry date: 12 April 2021

​A leading oncology biotech in the DC area requires a Senior Medical Director to lead clinical research programs in hematological malignancies; providing medical input to all aspects of product development and manage products in various stages of development (Phase 1-4). You will serve as scientific and medical member for clinical teams working closely with clinical project lead, the regulatory lead, and the operational leads. The primary focus is oncology indications but may also manage non-oncology products. You will develop clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.

Responsibilities and Job Duties:

  • Collaborates with colleagues in clinical development, clinical operations, research, data management, manufacturing, regulatory affairs, and product safety to assure effective protocol development and study design.

  • Provides technical support for site monitoring, safety reporting, and regulatory interactions in a manner consistent with Good Clinical Practice.

  • Assures the safety of the patients participating in the Company’s sponsored clinical trials by ongoing assessments of adverse events including potential causality

  • Interacts with the pre-clinical team, to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.

  • Provides medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.

  • Collaborates with clinical pharmacologist to interpret pharmacokinetic and toxicokinetic data and the implications for clinical study design.

  • Responsible for medical components of the study design, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications.

  • Directly develops and guides development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high-quality documents.

  • Directs protocol implementation through communication with site investigators and their staff. Leads site initiation meetings and follow-up meetings with investigators.

  • Contributes to the preparation of abstracts, presentations, and manuscripts.

  • Organizes clinical advisory boards, and steering committees in collaboration with Medical Affairs where needed.

  • Provides expert evaluation of Investigator initiated proposals in support of Medical Affairs

  • Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.

  • Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and local practices as applicable.

Minimum Qualifications

Education & Other Credentials:

  • M.D., or D.O. with subspecialty and board eligibility/certification in oncology

  • Significant experience in Oncology drug development may substitute for oncology specialization

Experience:

  • Minimum of 5 years of successful clinical research and/or drug development experience in biologics

  • Several years of experience working in the field of oncology

  • Possesses a mix of both early and late phase clinical development experience

  • Two years of clinical development experience for/in the pharmaceutical/biotechnology industry setting

The company is a large and developing oncology biotech with first in class new products in both solid tumor and hem onc studies. The Senior Medical Director is a key post and will offer an opportunity to rise to VP at an early opportunity.


For more information on this role please CLICK APPLY and forward an up to date resume.

Salary: $280,000 - $320,000 Per annum