Head of Clinical Development
Job Location: Boston or Remote
Position: Executive Director / Vice President, Clinical Development
Location: Cambridge, MA or remotely based anywhere in the US
Reporting to: Chief Medical Officer
Our client is a well-funded, clinical-stage neuroscience biopharmaceutical company developing several different diagnostic and therapeutic platforms to detect and target neurodegenerative disease pathologies, leveraging both small molecules and biologics. They are currently advancing the first of their best-in-class non-invasive diagnostics (PET) tracers that target pathological protein aggregates for neurodegenerative diseases, including Alzheimer’s Disease and Parkinson’s Disease.
- Their therapeutic programs (including both small molecules and biologics), have lead candidates discovered through screening platforms to precisely neutralize the pathological protein aggregates.
- Their small molecule programs have identified compounds that either switch the balance from toxic aggregates to native forms (modulators) or remove distinct protein aggregates (degraders).
- Their lead antibodies can block toxic protein aggregates in the extracellular space and stop their spread to slow or even prevent disease progression.
The Executive Medical Director / VP (ED/VP) will be responsible for leading clinical development programs for the company and will report to the Chief Medical Office. The (ED/VP) will support the strategic, clinical and regulatory aspects of all programs and will serves as the Global Project Medical Lead for clinical and imaging trials in AD, and orphan disorders such as PSP and FTLD, ensuring compliance with ICH/GCP and federal regulations.
Primary responsibilities include:
- Provide Medical and Clinical Development expertise and leadership to early-stage clinical development programs
- Design and draft clinical development plans, protocol synopses, clinical trial protocols and protocol amendments. Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
- Partner with Clinical Operations and provide leadership and direction to clinical project teams
- Establish and maintain positive relationships with clinical trial investigators/physicians, KOL’s and clinical advisors through independent collaborations and scientific meetings
- Support Data Monitoring Committee’s during the conduct of clinical trials
- Provide clinical development support for regulatory agency engagements and documents including INDs and BLAs
- Provide strategic input on compounds in development and propose clinical development strategies
- Provide medical expertise as needed for business development initiatives
- Provide medical and scientific expertise to preclinical discovery groups for compounds that are in
Education and Skills Requirements:
- MD required, subspecialty training in neurology is preferred
- 10+ years of hands on pharmaceutical or biotech experience in clinical development. Rare/orphan diseases preferred, but not required
- Experience in early-stage clinical development, phase 1-2 required; late-stage experience preferred.
- Strong neuroscience therapy and biomarker, including imaging background is highly preferred
- Prior IND/CTA and/or NDA/MAA filing experience
- In depth knowledge of drug development process and oversight of clinical trials
- Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
- Excellent interpersonal, written, verbal and visual communication skills
- Proven ability to successfully manage multiple tasks and prioritize accordingly
- Professional and pleasant demeanor
- Recognized by former peers, colleagues, managers and direct reports for the following attributes Drive, Excellence, Resilience, Teamwork, Innovation and Compassion