Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.
COMPANY OVERVIEW :
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases.
We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis.
Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
POSITION OVERVIEW :
Disc Medicine has an exciting opportunity for an ambitious physician to be Senior Medical Director. Reporting to the CMO, this position will support the Company's late-stage bitopertin program.
The Senior Medical Director will work with the cross-functional program team to drive the clinical program to NDA and lead studies in additional genetic and hematologic indications.
RESPONSIBILITIES :
- Lead the clinical study team in the planning, executing, and analyzing clinical trials.
- Represent the clinical study team at the clinical sub-team 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.
- Participate in Investigator meeting planning and execution and on-site initiation meetings.
- 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 by providing medical expertise for in- or out-licensing, partnering, and acquisition activities.
- 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 reviews.
- Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination.
- Travel, as needed, nationally and internationally.
REQUIREMENTS :
- MD with research experience or MD / PhD; fellowship training in hematology, oncology, nephrology, gastroenterology, or diology preferred.
- Extensive experience in translational or clinical research related to drug development is required; biotech / pharma experience is favorably considered.
- Experience with developing clinical and regulatory strategies.
- 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 of clinical research methodology principles, 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.
- Ability to think strategically.
- Willingness to take on new responsibilities.
- Commitment to thoroughness.
Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities.
We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.
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