Vice President, Clinical Development (MD)
401K, Dental, Life, Medical, Vision
Why Work Here?
“50-person small company atmosphere but with stable 100 year old parent company backing. 30k employees globally. Headquarters is in Japan.”
Clinical medical lead (SVP/VP) will provide strategic direction and technical leadership to the clinical development group including: clinical trial design, implementation and execution, data analysis and management. This role will provide medical and scientific expertise in collaboration with cross-functional teams to ensure successful execution of clinical activities, data analysis, and interpretation and oversight of CROs. Working closely with the leadership team, clinical lead will develop and execute regulatory and Phase I-II clinical trial strategy and design. This role will report to the President of Nitto BioPharma.
Duties and Responsibilities Include but Are Not Limited to:
- Responsible for working with CROs to complete clinical portions of regulatory filings, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, and benefit/risk ratios.
- Participate in study team meetings, Data Monitoring Committee (DMC) and steering committees as required.
- Develop and maintain key opinion leader relationships and serve as the medical lead for advisory meetings.
- Establish and maintain relationships with alliance partners, external companies especially CROs, investigators and opinion leaders to optimize performance on clinical trial activities.
- Accountable for clinical portion of regulatory documents such as Investigator Brochure update, and Drug Safety Update Reports.
- Manage and be responsible for pharmacovigilance for clinical projects including review and reporting of SAEs with support from pharmacovigilance providers as available.
- Participate in business development processes as needed
- Work collaboratively with Research providing clinical input into new target selection and preclinical studies
Desired Knowledge and Abilities:
- Critical, creative and deep thinker.
- Demonstrated ability to think strategically and successfully operationalize ideas and visions
- Excellent communications skills; team member that can work collaboratively and extremely well with colleagues across all functions and levels.
- Excellent work ethics and respect for colleagues at all levels
- Demonstrated track record as a solid, thoughtful leader with exceptional interpersonal skills.
- Demonstrated experience of FDA/EMEA/Japan PMDA requirements, good clinical practices and pharmaceutical clinical development in oncology and or fibrosis.
- Excellent analytical and strategic planning skills, with a track record of recruiting and/or out-sourcing high-performing clinical teams.
- Proven organizational skills and ability to handle multiple diverse projects simultaneously.
- Ability to maintain a problem-solving attitude in response to time demands and unexpected events.
- Ability to succeed in a deadline-driven environment.
- Ability to work accurately with close attention to detail.
- Ability to adapt to changes in company structure and responsibilities.
- Ability to travel domestically and internationally.
- MD required
- Minimum 10 years’ industry experience in drug development in biotech or pharmaceutical company
- Extensive experience in clinical trial protocol development, conduct, data analysis, regulatory submissions and regulatory authority interactions.
- Strong knowledge and respect of ICH /FDA / EMA regulations and guidelines, and applicable international regulatory requirements
- Experience with RNA-based drugs (siRNA, mRNA) is highly valued
- 4 years of experience in people management including direct reports preferred
- Extensive experience working in multifunctional and multinational teams
- Clinical practice and/or industry experience in Oncology or Fibrosis is highly valued
Physical Job Requirements:
Office/Lab environment. Lifting up to 25 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
Disclaimer: This job description reflects management’s assignment of essential job duties; and nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
About Nitto BioPharma Inc.:
Nitto BioPharma, Inc., is a biopharmaceutical company focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Clinical assets include their first anti-liver fibrosis drug program (ND-L02-s0201), which is now in Phase 1b/2 trials in the US, Europe, and Japan. Nitto BioPharma is also advancing several programs for intractable diseases including Oncology and fibrosis. Along with the establishment of the new company in April 2016, in mid-2016 Nitto BioPharma moved into our new R&D facility on Science Center Drive in San Diego, California.
Company website: http://nittobiopharma.com
Company address: 10628 Science Center Drive #100, San Diego, CA 92121