Ohana Biosciences is seeking an outstanding Head of Clinical Operations
Ohana is pioneering a new frontier in reproductive medicine building on novel, proprietary understandings of sperm biology. Sperm is an essential yet often ignored aspect of reproductive health. Understanding sperm biology provides deep insights into fundamental reproductive issues that have proven untreatable by studying eggs. Through its proprietary platform, Ohana is creating a suite of products that have the potential to increase success rates for assisted reproduction, reduce the disease risk associated with paternal age and exposure, reduce the transmission of disease-causing genetics to offspring, and introduce the first highly effective, non-hormonal contraceptives for men and women. These products will reshape reproductive medicine, taking a science-driven approach towards new product development, and will broadly meet the needs of patients, transforming the entirety of the industry.
We are seeking a Head of Clinical Operations to join a highly dynamic and intellectually challenging team. This key leadership role will afford a qualified candidate an opportunity to work in an innovative, fast-paced environment and shape Ohana’s vision to bring new products to patients.
The Head of Clinical Operations has the overall operational responsibility for the delivery of the Ohana clinical trial pipeline. They will be accountable for managing the clinical operations resources, ensuring efficient and effective allocation, and enabling delivery of data from reproductive medicine clinical trials. The successful candidate will be accountable for developing the plans to implement early proof of concept studies with rapid progression into larger commercial-launch, facilitating studies for our fertility-enhancement devices. The Head of Clinical Operations will work with the fertility program teams to ensure projects are performed within budget, on schedule and in compliance with the appropriate and quality standards. This individual will be responsible for the development of clinical SOPs with the QA function, ensuring Ohana is always inspection-ready and compliant with all national and international regulations.
What You’ll Do
Ensure that clinical-stage programs achieve their related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
Develop, maintain, and report on program budgets, including long-range forecasting and monthly accruals, in support of Ohana’s financial goals
Develop the Clinical Operations function to be ready for the execution of early and late-stage clinical development supporting marketing of devices and therapeutics
Establish and lead team of internal and external multi-functional stakeholders focused on program management and study execution; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including selection and oversight of CROs and other vendors/external partners
Act as a key member of the Ohana Research and Development management team with accountability for all aspects of clinical operations
Build and maintain effective relationships with Investigators, Regulatory Authorities and CROs in implementation of study protocols, collaboration on feedback, etc
Implement and maintain sound business practices
Work in and drive a team-oriented environment, motivate and influence others, lead strategic discussions, and interact with critical internal and external stakeholders, including the development program team, the Clinical Development Subteam, Principal Investigators, KOLs, CRO partners, patient advocacy groups, and regulatory agencies
Lead the continuous improvement of clinical operations through the establishment of working teams/ initiatives as needed
Partner effectively with essential subject matter experts in data management, safety/ pharmacovigilance, clinical supply and CMC, biostatistics, medical writing, quality assurance, regulatory and medical affairs
What Skills You’ll Bring
15 years + experience in clinical operations
7+ years experience in early development
5+ years experience in full development
Experience completing the full submission process
2-5 years in a supervisory role managing clinical operations staff
Willingness to travel domestically and internationally (up to 30% of time)
Thorough knowledge of drug discovery and development program management, from IND- through BLA, as well as experience in preparation of clinical sections of device submissions, INDs, BLAs/ MAAs
Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA, as well as those defined by international regulatory bodies in specific locations. Thorough understanding of cross-functional processes involved in study design and execution, including protocol development, data management, safety/ pharmacovigilance, biostatistics, medical writing, quality assurance, regulatory and medical affairs
What We’ll Offer You
Daily on-site snacks, coffee, and Bevi, as well as monthly catered lunches.
Comprehensive, competitive healthcare (PPO) and dental coverage through Blue Cross Blue Shield, and vision coverage through VSP.
Life insurance and disability through USAble Life.
A 401K retirement plan.
15 days vacation and 5 sick days per year, as well as 10 company-paid holidays.
Why Join Ohana Biosciences
Based in Cambridge, MA, Ohana is a venture-funded early-stage startup founded by Flagship Pioneering in 2015 through its venture creation engine, which founded over 40+ breakthrough companies including Seres Therapeutics, Agios, Moderna, Editas, Denali and Codiak.
Ohana Biosciences is revolutionizing male reproductive medicine with a world-leading understanding of sperm biology through rigorous science. We will responsibly develop technologies that:
Prevent inherited disease;
Deliver a highly effective, safe, reversible, non-hormonal contraceptive; and
Treat male infertility, traditionally ignored but responsible for half of infertility issues.
We strive to maximize access to our treatments that address the broad reproductive needs of individuals and families.
Our enthusiasm, ambition, drive, and creativity, coupled with our unique blend of innovation, basic biology and business focus, creates an exciting entrepreneurial environment set to disrupt an area of medicine in need of substantial improvement for patients.