Sr. Vice President, Clinical Operations and Program Leader

We are seeking a collaborative, dynamic, and experienced Sr. Vice President of Clinical Operations and Program Leader. Reporting to Frontier’s Chief Medical Officer, the SVP will advance Frontier’s lead compounds, as single agents or in rational combinations, into clinical trials of cancer patients with a range of solid tumors. The successful candidate will have a passion for novel science, an affinity for strategic thinking, an aptitude for looking beyond the day-to-day execution, and a record of leading early-stage and mid-stage clinical programs to critical milestones. The Sr. Vice President will be responsible for evaluating and improving clinical trial operations, identifying innovative solutions, and optimizing processes for efficient study execution. The Sr. Vice President will lead a team of professionals and collaborate with key stakeholders to ensure adherence to regulations, guidelines, and industry standards. They will also foster relationships with external partners, including CROs and experts, to support clinical study activities.

Requirements

What will you be doing?

• Provide clinical development project leadership and develop and implement clinical operations strategy to ensure the successful design and execution of clinical programs.
• Provide strategic guidance, operational leadership, and expertise to drive the implementation and execution of clinical trials.

• Manage the growth and operations to support clinical development as well as the career development of direct reports.
• Creation of clinical documents required for the conduct of the clinical development program and studies.
• Clinical leadership in clinical study and program teams, and of clinical communication to upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and development/presentation of a plan of action for resolution of issues.
• Data monitoring and review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs.
• Collaborate with CMO and other Senior Leadership Team members to identify and close gaps in policy, procedures, and infrastructure for Frontier’s clinical development function, and take ownership of organizational development initiatives as agreed upon with CMO.
• Collaborate with communications team to engage patient advocacy groups to inform clinical trials.
• Collaborate effectively with both internal and external development functions including Regulatory, Pharmacovigilence, Statistics, Data Management, and Clinical Operations.
• Prior experience with developing regulatory strategies for key milestone meetings including briefing documents/responses including submitting regulatory filings (NDA, BLA) and obtaining orphan drug designation is a plus.

• Maintain relationships with external partners, including CROs and experts, to support clinical study activities.
• Ensure compliance with regulations, guidelines, and industry standards throughout the clinical trial process.
• Provide regular updates and reports on the progress of clinical programs to executive team.
• Provide leadership, strategic planning, and effective management of the Clinical Operations and Clinical Development Project Leadership functions.
• Facilitate and participate in the selection and management of clinical outsourcing vendors.
• Program Management of clinical stage programs from an operational perspective.
• Oversight and management of clinical trial budgets and staffing to achieve program timelines and goals.
• Lead and/or collaborate in the creation, review, and updating of regulatory and study documents, including but not limited to INDs, NDAs, clinical study protocols, Informed Consent Form (ICF), and other patient-facing materials, case report forms.

Traits we believe make a strong candidate:

• Advanced degree (MD, PhD, PharmD, MBA, or equivalent) preferred.
• Minimum of 15 years of experience in clinical operations, including significant leadership experience.
• Strong knowledge of the drug development process, regulatory requirements, and clinical trial design.
• Demonstrated track record of successfully leading and executing clinical programs.
• Proven ability to collaborate with cross-functional teams and external stakeholders.
• Excellent leadership, communication, and interpersonal skills.
• Ability to navigate complex and dynamic healthcare environments.
• Strong problem-solving and decision-making abilities.
• Familiarity with domestic and international regulations in the pharmaceut