Director/Senior Medical Director, Hematology
This is an uncommon opportunity for an ambitious physician to be Director/Senior Medical Director, Hematology in a small hematology biotech that is currently at an inflection point of rapid growth. Reporting to the CMO, this position will support one of the two clinical-stage programs focused on heme metabolism. The Director/Senior Medical Director, Hematology will work with the cross-functional program team to drive the clinical program from Phase 2 to pivotal trials across a number of genetic and hematologic indications.
Job Duties & Responsibilities:
- Lead the clinical study team in the execution of clinical trials
- Represent the clinical study team at the clinical subteam and program team
- Collaborate closely with the internal research team to integrate translational research into development and clinical strategies
- Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and principal investigators
- Lead internal and external team members, vendors, and consultants to develop, review and evaluate data for regulatory submissions
- Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and clinical expert reports
- Organize and present at relevant clinical advisory boards, DMC and medical/scientific meetings
- Support business development processes by providing medical expertise for in- or out-licensing, partnering and acquisition activities
- Travel, as needed (and permitted), nationally and internationally
- Participate in Investigator meeting planning and execution and/or on-site initiation meetings
- Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review
- Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
- Help to determine appropriate advisory boards experts
- Ability to think strategically
- Willingness to take on new responsibilities
- Attention to detail
- MD with research experience or MD/PhD, as well as a fellowship in Hematology/ Oncology or related areas
- Extensive experience in translational or clinical research related to drug development is required: biotech/ pharma experience favorably considered
- Experience with developing clinical regulatory strategy
- Ability to identify and build relationships with thought leaders and leading clinical centers
- Strong academic record with high quality peer-reviewed publications that demonstrate research productivity
- Track record of effective cross-collaboration within an organization, among teams, and external groups/organizations
- Expertise in data analysis and presentation
- Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
- Ability to clearly and effectively communicate to internal and external stakeholders orally and in writing
- Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
- Strong business acumen; including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
ABOUT DISC MEDICINE:
The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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