Regional Team Lead – Clinical Operations Study Start-Up| Oncology | Unique Leadership Role | Remote based – Asia | Fast Growing Biotech: RETAINED SEARCH
This is a very attractive newly-created leadership position where you will manage your own Clinical Operations Study Start-Up team in APAC. You will provide strategic and hands-on operational leadership for all regional study start-up activities conducted within the Company’s oncology portfolio, and you will be a very important/visible part of the growth of this expanding department and in conducting a Global Phase 3 registrational study for the company’s lead asset to treat breast cancer. This is a very unique “ground-floor” opportunity to utilize your hands-on leadership experience. You must have a strong understanding of the APAC country requirements and the proven ability to interface and manage confidently across the entire region.
Our client is an attractive, stable, and fast-growing biotech company (publicly-traded) focused in oncology. This is a very exciting time within the organization, as they have been growing quickly across a number of departments all over the world, including Asia. This is a great opportunity to join an exciting and very financially secure company at the ground-floor and have the ability to truly influence and impact the direction of the organization. This company has been attracting experienced and talented industry professionals and offers the “best of both worlds,” (i.e. small team comradery and a nimble, entrepreneurial environment where smart decisions are made quickly minus the red tape/bureaucracy, while also having the stability/resources/financial backing of its parent company with deep pockets to fund its Oncology development and pipeline).
Location: This is a remote-based position where this person can be based anywhere in Asia.
Attractive Features about this Company & Opportunity:
- Unique “Building” Opportunity: This is a uniquely exciting opportunity where you will have the autonomy to hire and manage your own team in the APAC region.
- Newly-Created Leadership Role: You will be the first person hired into this role, so you will have the opportunity to create what and how its footprint will look like within the organization.
- “Best of Both Worlds” (small Biotech culture combined with stability and resources): The company offers all the attractive features sought with a quickly growing entrepreneurial Biotech (small team comradery, high-impact, agility, quick decision-making, minimal bureaucracy) without the typical risks associated with a “start-up.” Our client offers a flat organization structure with minimal layers of management, “red tape,” internal politics and bureaucracy which fosters more communications and swifter decision making (i.e. emphasis on progress and moving things forward).
- Excellent Hiring Manager: You will report into an excellent department Head (whom we know personally) who is experienced, smart, personable, well-liked and well-respected.
- Great Time to Join: Now is a perfect time to join this company while they are at the ground-floor and an exciting inflection point as they are advancing into Phase 3 development with their lead asset to treat metastatic breast cancer.
- CEO’s Track Record of Success: The CEO has extensive leadership experience and an impressive track record of success in creating and leading successful biotech companies that are focused on developing treatments for life-threatening and debilitating diseases.
- Unique Culture & Forward Thinking Organization: a collegial, collaborative and enjoyable culture where people are highly engaged, smart, enthusiastic, and passionate about making a difference in the lives of cancer patients.
- Provides operational leadership and oversight of startup activities for the APAC region.
- Responsible for management and oversight of activities performed by Study Start Up Managers and SSU Associates.
- Oversight, management, training, and development of SSUAs to support startup activities (site and country feasibility, ethics and IRB submissions, review and finalization of essential documents, and other activities required for site initiation).
- Evaluate ongoing Study Start-Up team progress, quality, and performance.
- Lead the country and site feasibility for the APAC region.
- Oversight and execution of a comprehensive IRB/IEC submissions process ensuring start-up documentation meets the specifications required by local regulations, EU directives, ICH-GCP and FDA regulations.
- Track progress for region against study start-up timelines and milestones and support development of mitigation plans for identified risks and assist with plan execution.
Education & Experience:
- An advanced degree in life sciences, nursing or related field is preferred.
- 10+ years of relevant and progressive experience in clinical operations/study/team management gained working at a pharmaceutical and/or biotech company, or a CRO.
- Experience and expertise in study start-up.
- Oncology experience is required; Phase 3 experience is strongly preferred.
- Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior management.
- Willingness to work in a player-coach capacity (i.e. “hands-on”, roll-up-your-sleeves and pitch-in whenever necessary).
Brian Skurka, Director
email@example.com - P 973-656-0220 x738
Cornerstone Search Group, LLC
6 Campus Dive
Parsippany, NJ 07054
Keywords: Clinical Site Management, Global Site Management, Clinical Site Monitoring, Lead, Associate Director, Clinical Operations, Monitoring, Group Head, CRA, Clinical Research Associate, Regional Lead, Clinical Study Management, Clinical Study Manager, Project Manager, Project Management, Trial Management, Global Study Operations, CRA Manager, Site Management