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Director/Senior Director of Clinical Development
2 months ago
About the Company:
We are tackling one of the largest problems in healthcare – and you can too. For patients suffering from autoimmune or immune-mediated conditions, trial-and-error approaches are commonly used to determine the appropriate therapy. At Scipher Medicine, we are developing an innovative portfolio of personalized medicine solutions in autoimmune and immune-mediated diseases. Scipher's platform identifies and guides physicians towards a more targeted approach to determine the best treatment for their patients, based on their patient’s own fundamental disease biology. We have a growing pipeline of products being developed in the autoimmune and immune-mediated disease space and the potential to predict which therapies patients will respond to, ensuring optimal treatment is prescribed from day one of diagnosis.
Our commercially available test, PrismRA, is a personalized precision medicine test that helps guide healthcare providers’ treatment decisions in patients with rheumatoid arthritis.
Scipher Medicine is a precision immunology company on a mission to match each patient with their most effective therapy and bring forward the day when every autoimmune disease patient reaches remission, and no one suffers in silence.
Basic Qualifications:
- Advanced degree in life sciences (PhD, PharmD, MD, DO).
Extensive experience (5+ years) in clinical development, preferably in the biotech industry/medical device/LDT or pharmaceutical industry.
- Experience in clinical program management, clinical development strategy, and study design/trial management and reporting.
- Demonstrated experience with major regulatory submissions (LDT, IVD, NDA, BLA, MMA).
- Proven track record in leading cross-functional teams.
- Proven ability to interpret complex clinical data through written and presented content.
- Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
Preferred Qualifications:
- Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise with publications and presentations.
- Demonstrated strength in communication and relaying technical information accurately and concisely to a variety of stakeholders.
- Demonstrated excellence in stakeholder management.Demonstrated skills in networking internally and externally and communicating in situations requiring special tact and diplomacy.
Overview:
- Work collaboratively cross-functionally.
- Act as a key intermediary with alignment between Medical Affairs, Regulatory Affairs, Market Access, and Data Science teams, as it pertains to gap analyses and development of new analysis plans per the identified needs of the organization.
- Independently evaluate, discuss, present, and explain material of moderate to high complexity regarding our pipeline as well as our competitors.
- Actively lead/participate in Product/Clinical Development, Clinical Program Oversight, Study Management, Scientific Expertise and Governance.
- Ensure clinical, operational and medical governance excellence across all clinical development projects for assigned projects.
Scientific Expertise and Governance:
- Possess scientific credibility and operational expertise.
- Interpret complex clinical data.
- Guide evaluation of emerging clinical trial data, data interpretation, and data mining.
- Oversee literature searches, meta-analyses, and data publication in conjunction with Medical Affairs.
- Maintain expert knowledge of products, disease indication and regulatory standards within the defined scope of the company.
Strategic Planning:
- Contribute to the integrated clinical development strategy and clinical development plans.
- Integrate clinical development objectives into and aligning with strategic business goals.Ensure consistency with clinical development strategy for regulatory approvals, reimbursable medical devices, and successful lifecycle management.
- Integral in developing the evidence package addressing key evidence gaps and strategy for pipeline indications (e.g., clinical and economic impact, patient journey and perspective, comparative effectiveness research).
Responsibilities:
Product/Clinical Development:
- Responsible for the development of clinical trials across autoimmune/immune-mediated indications from early stage to late stage. Design and assist with execution of clinical trials.
- Collaborate with cross-functional teams (Data Science, Medical Affairs, Clinical Operations) to achieve project milestones.
- Manage clinical trial budgets, timelines, and resources.
- Ensure compliance with regulatory requirements and ethical standards.
- Lead the Drafting/Reviewing/Editing of clinical study summaries, protocols, CRFs, and study reports in collaboration with Clinical Operations, Data Science and Medical Affairs.
- Ensure studies are conducted according to GCPs and Departmental SOPs.
- Consult as needed in strategic design of investigator sponsored studies and other investigator-initiated studies in conjunction with Medical Affairs.
Scipher is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law
