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2018-1847# of Openings
Clinical Dev - DeptOverview
The Senior Medical Director, Oncology Clinical Research provides active scientific contributions to a cross-functional clinical team developing compounds currently being studied for new oncology applications. Responsibilities
- Provides Key Medical expertise and input in support of the development and management of the oncology pipeline.
- Participates in the interpretation and reporting of the results of research, including submission health authorities.
- Assists in the preparation of protocol writing for and operational execution of clinical studies.
- Interprets data, assesses the integrity of trial data and provides scientific summaries.
- Provides support for the regulatory documentation and submissions for the clinical program.
- Works closely with the biostatistics team to complete the statistical analysis plan.
- Works with the Clinical Operations, Research, Medical Writing, Medical Affairs, Program Management, CMC and Regulatory Affairs teams to deliver and drive the completion of all clinical activities on time and within budget.
- Identifies Contract Research Organizations ("CRO") or other outside collaborations that will enable Radius to develop models or apply expertise to a team that is not currently available in-house.
- Evaluates scientific information and new ideas to assist in identifying new research opportunities.
- Supports medical affairs activities involving product evaluation, labeling and surveillance.
- Assesses external clinical research proposals involving company products and manuscripts that are being prepared for publication.
- Acts as a liaison between the company and clinical investigators.
- Develops credible relationships with opinion leaders and clinical research staff in other countries.
- Integrates relevant scientific findings from the trials and the literature, to facilitate research and overcome scientific challenges.
- Collaborates, monitors and reports CRO based study results to the project team.
- Supports and contributes to the development of overall program clinical development plan.
- Participates in Clinical Advisory Meetings and Investigator Meetings.
- MD is Required
- Trained Oncologist (Board certified or eligible) strongly preferred.
- Post-doctoral fellowship training is required.
- Minimum 8 years' experience in a clinical research position within the pharmaceutical industry is preferred.
- Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important.
- Experience with estrogen responsive tumor types is valuable.
- Demonstrated expertise in drug trial design, authoring and successful implementation of clinical protocols and clinical study reports
- Strong experience reviewing & interpreting study data/reports and presenting findings to project team members.
- Experience in building and maintaining effective relationships with external KOL's, advisory boards and other key external therapeutic area influencers.
- Excellent organizational, written and oral communications skills.
- Demonstrated experience in scientific writing.
- Demonstrated ability to effectively work with a diverse range of people.
- Ability to quickly adapt to a changing work environment; comfortable with ambiguity while possessing a "roll up your sleeves" attitude and approach.
- Possesses a collaborative, results-driven style.
- Ability to motivate, collaborate and provide leadership in a growing enterprise.
- Exhibits integrity, honesty and a sense of personal accountability.
- Proficient in office based computer skills including Word, Excel, PowerPoint, etc.
- Travel for this role is expected to be up to 20%, focused on interfacing with KOLs, investigators, and trial sites.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.
Location/Region: Waltham, MA (02451)