Director/Sr. Director, Global Clinical Operations
- Cambridge, MA
Director/Senior Director, Clinical Operations
This is a great opportunity to join a passionately driven group that is changing the way immunoconjugate therapies work by leveraging their patented platform to create precisely targeted and highly tailored drugs that radically improve cancer patients’ lives. The company is using their highly differentiated ADC Platforms to create a pipeline of clinically meaningful candidates
This is an opportunity to make a visible impact through your strategic and scientific input and by using your knowledge, experience and ability to build clinical expertise and drive team excellence for the development of their assets.
The senior management team possess an extremely impressive track record and a strong commitment to scientific excellence and patient care.
They have cultivated a collaborative workplace and a shared passion to advance therapies that make a significant difference in the lives of cancer patients and their families.
Business Highlights and Upcoming Milestones:
- Phase 1 dose escalation of lead compound, a novel NAPi2v-targeting ADC in patients with solid tumors was well tolerated.
- Tumor types included 22 ovarian, fallopian tube, primary peritoneal cancer, four NSCLC, eight endometrial, two papillary renal, and one salivary duct cancer. Patients were heavily pre-treated, with a median of four prior lines of treatment (range 1-13) for all patients and a median of five lines of prior treatment in ovarian cancer patients (range 1-11).
- Q3 2019 dose expansion phase begins. Site selection complete (from 7 sites to 25).
- IND Filing and planning to disclose next clinical candidate in 1Q 2020
- Looking to further to expand its patent portfolio to treat broader populations of cancer patients
- The company continues to advance their strategic collaborations and partnerships with leading pharmaceutical and biotech companies
This is an exciting opportunity for a highly motivated individual to guide the clinical strategy and operations for their drug development programs.Depending on interests and expertise, this person will lead and/or mentor colleagues with less experience and ensure processes are optimized for maximum efficiency and GCP compliance.This position involves both high level strategic planning as well as hands-on responsibilities, global clinical oversight to support the growing pipeline.
- Playing a leadership role in facilitating the clinical development process
- Leading cross-functional teams from various external partners and internal departments in the development and execution of clinical trials.
- Developing cross-functional study plans for use with external partners and internal teams
- Contributing to the design of clinical studies in close collaboration with the Medical Lead and the clinical development team
- In collaboration with clinical and other cross-functional groups, participate in creating materials for investigator meetings, scientific advisory boards, DMCs, and steering committees, such as preparing abstracts, posters, presentations and publications
- Tracking study timelines and running different scenarios based on development plan contingencies
- Review protocols and work with internal and external teams to ensure company’s research requirements can be met by clinical research personnel
- Providing input on CRF design, statistical analysis plan and drug supply planning
- Providing opportunities for on-the-job and didactic training in clinical strategy and execution
- Participating on periodic patient safety and efficacy reviews
- Extensive experience monitoring the throughput and quality of work conducted by the external parties conducting SEVs, SIVs, PMVs, and COVs is required
- Ability to organize and manage multiple priorities: your own and those of work teams you oversee and support
- A thorough understanding of and the ability to operationalize MAA, FDA, GCP, ICH, and eCTD compliance standards, and relevant regulatory requirements
- Experience communicating with research site personnel
- Expertise in authoring clinical documents
- Expertise with PowerPoint and MS Project
- Experience preparing regulatory documents for submission
- Experience in vendor identification, RFP development and review, and the development and use of balanced score cards for proposal and performance evaluation
- Experience as a program manager ensuring program time lines are met
- Demonstrated strong analytical and strategic thinking skills
Located in MA. This publicly-held biotechnology company has a unique and proprietary platform for immunoconjugate therapies allowing them to advance beyond the limitations of other antibody drug conjugate approaches. They have four differentiated, proprietary ADC platforms.
Their technologies enable them to design ADC’s with improved efficacy, safety and tolerability to target tumors with greater therapeutic payloads.
The company is advancing their proprietary pipeline through early clinical development and is leveraging partnerships with leaders in the field to accelerate the development of important medicines created with this platform.
The company recently announced encouraging results with early signs of efficacy coupled with a favorable safety and tolerability profile and promising treatment duration for their lead program. They are currently enrolling patients in their dose expansion phase of the study focusing on platinum-resistant ovarian cancer and NSCLS adenocarcinoma patient populations.
With these positive trial results and advances in the clinic the company is increasingly more confident that their platform has the potential to effectively treat a variety of cancers.
Corporate Facts and Culture:
- 78 person and growing publicly traded company
- Committed and dedicated to team members’ personal and professional development
- Very strong and unified senior management team.
- Transformative stage company, quickly moving from discovery to clinical
- Open environment, including C-Suite
- Dog friendly office, bring your dog to work!
- Everyone has a voice and will be seen and heard from
- Industry leader in their therapeutic area
Strategic Leadership Objectives:
- Shape the clinical development process to address with a commitment to putting patients first.
- Work closely/lead the Clinical Development team supporting the Vice President in the creation and execution of global clinical development plans and studies
- Represent high value program(s) to Senior Management
- Key contributor to the continuous development of a corporate environment that is thoughtful about strategy and tactics, culturally intellectual and energetic.
Clinical Development Objectives:
- Build and drive clinical development plans for POC for lead program.
- Ensure timely initiation, execution and reporting of US/Global clinical trials
- This organization continues to grow and in-turn this will open up more and more leadership opportunities. This hire will work closely with the company’s VP, Clinical Development/Operations dedicated to mentoring and sharing in overall strategic planning for clinical and pre-clinical assets.
- No organizational blocks for someone in this role that wants to move ahead.
Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders.
We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines. http://prestigescientific.com/
Director, Prestige Scientific
409 Fortune Blvd. Suite 202, Milford MA. 01757
Direct Dial: 508-469-1113
Cell: 617 650-6769
Assistant: Alison Corshia
Wednesday, February 12, 2020