Director, Clinical Operations (Tmf)

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate clinical studies in the following NSCLC indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (HARMONi)

• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (HARMONi-3)

Responsibilities:

The Director, Clinical Operations (TMF, CTMS) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions.

The individual leads transformative initiatives that create effective and efficient processes that meet high compliance standards; collaborating across Development (focus on Clinical Operations); serving as a change manager to implement new systems and practices that support the organization as we continue to grow.

The individual is an effective clinical operations team leader accountable for talent acquisition, development, management, and evaluation of team members in his/her/their group. This includes responsibility for the What (delivery to performance goals) and the How (deliver consistent with Summit Therapeutics core values).

The individual is also a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients.

This position reports to a VP, Head of Clinical Operations.

Summary of Key Responsibilities:

• Develop, implement, and oversee the CTMS and TMF systems and related processes

• Oversee TMF and CTMS vendors, contractors, and cross-functional teams

• Manage and develop existing TMF employees and lead by example by demonstrating our core values

• Develop, implement, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement

• Partner with key internal and external stakeholders to remediate risks and manage emerging issues.

• Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards

• Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations

• Lead a team of TMF and CTMs colleagues and ensure their continuous development

• Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals

• Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS

• Participate as an active member of the Clinical Operations Extended Leadership Team (XLT)

• Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections

• Instill a culture of continuous improvement; acts as a change champion and effectively leads change

• Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution

• Travel on assignment, = 25%

Requirements

• University degree (e.g. BA, BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred

• 12 years of strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS) preferred

• Experience in managing/leading others is also a requirement of the role

• Proven line and functional manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff

• Experience in Phase III execution of clinical trials in Oncology preferred

• Previous regulatory inspection experience preferred

• Comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines

• Solid vendor oversight experience including contracts and budget management preferred

Skills

• Excellent interpersonal, verbal, and written communication skills, including experience in delivering presentations at conferences, meetings, and training sessions

• Experience with Microsoft based applications and ability to learn internal computer systems

• Willingness to work effectively with multiple supervisors in a matrix environment and value the importance of teamwork

• Continuous improvement mindset with the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment

• Ability to concisely present significant issues and criticality to senior leaders

• Diplomatically address sensitive issues confidentially and professionally

• Ability to build and maintain relationships with internal (e.g. EAs) and external (e.g. CROs, systems vendors) leaders and their site staff

• Innovator, willing to initiate and champion changes, introduce new ideas, and creatively problem-solve

• Provide leadership to teams and projects to aid in successful conclusion

• Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines

• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups

• Demonstrate good judgment and decision-making experience

• Work professionally with highly confidential information

• Work independently and within a team

• Ability to delegate tasks to vendors and oversee delegated activities

• Ability to train new and existing less experienced Clinical Operations members

The pay range for this role is $180,000 to $230,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits human resources department to obtain prior written authorization before referring any candidates to Summit.