Director/Senior Director of Clinical Development (Scientist)
Concentric Analgesics, Inc. is a private, biotechnology company focused on discovering and developing novel, non-opioid therapeutics for the management of acute and chronic pain. Reporting to the Chief Medical Officer, This position will have responsibility for assisting the CMO in the delivery of clinical development activities for the CA-008 post-surgical indication and ensure consistency with the clinical development strategy to support regulatory submissions.
Key Roles & Responsibilities:
Be a major contributor to integrated clinical development strategy and plans.
Assure clinical studies are conducted effectively in partnership with Clinical Operations colleagues and CRO as appropriate.
Assist the CMO in authoring of study protocols, CRF's and contribute to development of analytical plans through discussion with matrix team members.
Review standard format data displays in TFLs and CRF's to assure consistency in data capture.
Be accountable for authoring of clinical study reports and Investigator Brochures.
Working with the CMO, be responsible for oversight of development and execution of studies linked to clinical development plans.
Working with the CMO, be responsible for integrating clinical development objectives into strategic business decisions.
Working with Clinical Operations CMC and Regulatory Affairs, ensure clinical, operational and medical governance excellence across all clinical development projects.
Assist in producing materials for Investigator meetings.
Participate in data review discussions and contribute to data interpretation
Assist with the preparation of regulatory briefing documents and clinical elements of regulatory submission documents
Assist with the writing of manuscripts and development of abstracts and presentation materials
Travel is expected to be minimal (<20%) over the first year and will be negotiable thereafter
Advanced degree in life sciences or allied field (PhD/PharmD/DDS/MD/DO)
Up to 10+ years of experience in the pharmaceutical industry
Experience in clinical program management, clinical development strategy and study design/trial management and reporting is a must
Must have demonstrated experience with major clinical document output (protocol design, CSR, safety summaries) and regulatory submissions (IND, EOP2 packages, NDA/BLA/MAA etc.)
Proven track record in working in multi-functional teams and ability to be effective in working with Clinical Operations, CROs and clinical sites.
Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise; proven ability to interpret complex clinical data
Demonstrated excellence in stakeholder management. This role requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and a good sense of humor.
Excellent communication skills are a must.
Possesses sound operational knowledge of the pharmaceutical industry and broader R&D processes including scientific activity impacting project work.
Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulatory guidances governing clinical research
Demonstrates a proven ability to both independently complete and lead peers in completion in components of complex plans, i.e. draft protocols, selecting appropriate methodologies, measures, analytical plans and evaluation tools.
Concentric Analgesics is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
The Human Resources team manages the recruitment and employment process for Concentric Analgesics. Unsolicited resumes sent to Concentric Analgesics from recruiters do not constitute any type of relationship between the recruiter and Concentric Analgesics and do not obligate Concentric Analgesics to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.
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