Clinical Program Leader
New York, NY | Contract
Bayside Solutions is seeking a Clinical Program Leader to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local Biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Program Leader
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in early development portfolio.
- Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams).
- Develop program timelines and budgets and manage variance.
- Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans.
- Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget.
- Develop and present operational plan to management review bodies.
- Identify program risks and develop and implement mitigation strategies for assigned programs.
- Define the resourcing and outsourcing strategy for early development programs.
- May participate in Business Development assessments.
- Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders.
- Partner with Business Management to identify strategic business needs to support the clinical programs.
- Partner with late-stage development leaders to ensure strategic alignment on the CDP Functional Management.
- Bachelor’ s Degree or equivalent required (scientific or healthcare discipline preferred) Advanced degree preferred.
- 10+ years’ experience of clinical and drug development, including 5+ years of clinical trial management experience and 2+ years of clinical program management experience.
- Working knowledge of international regulatory and ICH GCP guidelines.
- Demonstrated understanding, knowledge, and experience of drug development in a complex setting with particular focus on early development.
- Demonstrated experience in various therapeutic areas.
- Strong analytical and strategic agility skills.
- Exceptional leadership skills, including motivation and delegation.
- Strong financial acumen with experience managing clinical program budgets.
- Proven ability to implement and manage a clinical program (i.e. a series compromising a clinical development plan).
- Ability to drive, encourage and support innovation.
- Highly effective verbal and written communication skills in English.