The Company
My client is a biotech company who specialise in engineering regenerative medicine and are seeking a Senior Director, Clinical Development to join their dynamic team.
The Role
This position is responsible for the leadership and oversight of the clinical operations team, global clinical trials management and CRO partnerships. This position requires strong influencing and negotiation skills and the ability to introduce innovative and strategic concepts to both internal and external partners and stakeholders.
Responsibilities:
- Provide strategy, direction and oversight for the management of global clinical trials to include vendor selection, vendor management, day to day operational oversight of CRO partners and other clinical trial vendors
- Manage external partners, consultants, vendors and external budgets to ensure timely and cost- effective implementation of the Clinical Development Plan
- Develop and manage Clinical Development Budget including review and approval of contracts, work orders and invoices within grant of authority
- Participate in review and development of protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), Development Safety Update Report (DSUR), Development Plans to ensure alignment with strategic plans of the organization
- Develop, monitor and effectively manage Key Performance Indicators (KPIs) to track the progress of the ongoing clinical studies as it relates to CRO and other vendor performance
- Manage CROs, vendors and day-to-day activities associated with the conduct of clinical studies. This includes, but is not limited to, the following:
- Participate in discussions on the strategy for operationalization of clinical studies and site selection
- Review and approve study plans and other documents to ensure CRO and vendor compliance
- Ensure appropriate training of team members (including CRO staff)
- Develop and track clinical study budgets (planned versus actual)
- Includes review and approval of invoices against contracts
- Oversee IP distribution to investigative sites
- Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, and all applicable regulations
- Ensure that clinical studies are conducted in accordance with executed contracts and budgets
- Be a key interface and resource for investigators (includes monitoring in the field as needed) and vendors
- Identify need for, develop and/or review clinical SOPs as needed
- Represent the company’s at selected conferences and other meetings
- Collaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulations
- Effectively influence key internal and external stakeholders regarding matters of significance related to clinical trial management and clinical deliverables utilizing data and knowledge of company strategy as related to clinical trial management
- Provide all personnel management for clinical team direct reports to include, recruitment, retention, performance management, and career development
- Other duties, as assigned
Specific Skills
- Excellent knowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agents
- Strong background in conducting clinical trials and pharmaceutical industry drug development process
- Ability to lead discussions with executive management team on strategy and policy issues
General skills
· Able to communicate effectively in English, both verbally and in writing
· Excellent communication and interpersonal skills
· Possess a positive roll-up-the-sleeves attitude and optimistic outlook
· Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
· Excellent organizational and time management skills with ability to set own priorities in a timely manner
· High degree of flexibility and adaptability
· Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
· Must be able to work as needed to meet tight deadlines and at peak periods
· Self-motivated and organized critical thinker with solid interpersonal and business communication skills
· Demonstrated ability to work in a cross functional team
· Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements.
· Represents the organization in a positive and professional manner.
· Reports to work on time and as scheduled
Requirements
- At least 10 years PM/study management experience
- Both sponsor (CRO oversight) and CRO experience highly desirable
- Clinical background/experience preferable (e.g., nurse, clinical pharmacist, NP, PA)
- Recent NDA or BLA experience required
- 5-7 years of progressively responsible people leadership experience
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything