Senior/Executive Director, Program Leadership and Regulatory Operations

Job Description

Job Description

About Radionetics
Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel radiopharmaceuticals for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments and has entered into a strategic agreement with Eli Lilly. Radionetics is advancing a pipeline of first-in-class small molecule radioligands targeting G protein coupled receptors for the treatment of a broad range of cancers, including breast cancer, lung cancer, and other indications of high unmet need. For more information, visit

Position summary
The Senior or Executive Director, Program Leadership and Regulatory Operations is an experienced individual contributor and professional leading strategic program management company-wide. Reporting to the SVP of Regulatory Affairs, Clinical Pharmacology & Nonclinical Development, this individual has overall responsibility for the coordination of program leadership, regulatory operations and other projects across programs. The individual will coordinate critical pipeline activities leading to the successful transition of compounds in the discovery portfolio to preclinical development assets and manages the transition of compounds into early clinical development.

The incumbent plays a central, strategic role in planning, organizing and advancing portfolio development programs to facilitate timely and impactful Radionetics decisions. The Senior or Executive Director, Program Leadership and Regulatory Operations is critical for the strategic planning, execution, and delivery of overall program goals including regulatory goals, ensuring alignment with company objectives and regulatory requirements for oncology radiopharmaceuticals. The individual requires extensive knowledge of regulated drug development in the oncology therapeutic area, strong leadership, operational excellence, attention to detail, and a strong ability to work collaboratively in a multidisciplinary team setting spanning research and development.

Essential job functions and duties

• Lead development project teams, in a matrix environment, at all stages of development starting from IND enabling nonclinical program using in-depth knowledge of oncology drug development
• Strategically develop project plans for all Radionetics compounds transitioning from discovery into nonclinical development and, after IND clearance/IRB approval, from nonclinical development to into clinical development
• Oversee integration and implementation of project plans across functional areas, in a matrix environment, including discovery biology, nonclinical development, CMC, and clinical development across the entire program, to ensure optimal program execution in line with strategy
• Create and implement consistent and transparent processes, for e.g. propose clear criteria for DC declaration or minimal package needed for IND, that drive high quality planning and decision making
• Define schedule, key milestones, critical path activities, risks, and risk mitigation strategies by working with program team members across functional areas
• Conduct periodic project reviews with leadership team to get input to optimize program execution
• Work with stakeholders to identify inter-dependencies between functions and periodically update deliverables that can be shared with the team and management
• Support active portfolio management (resources, stage-gates) and decision making by monitoring progress of portfolio/program strategy, goals, and metrics by using project-related dashboards to identify key activities, progress and potential challenges.
• Balance risk management vs creativity to ensure program teams provide options (opportunities/risks) to exceed program timelines.
• Proactively identify and address potential challenges and opportunities impacting program progress and success.
• Lead regulatory operations including the following:
  • Lead all internal stakeholder communication of timelines for preparation and finalization of documents to be sent to the FDA
  • Providing and managing templates for regulatory common technical documents (CTD)
  • Manage document flow, getting stakeholder input, and finalization of regulatory documents being prepared for FDA submission
  • Manage internal regulatory SharePoint and SharePoint for external partners
  • Ensure that all documents submitted to the FDA and all communications to & from the FDA are available, by project, for review (using Rosetta Phoenix or similar software)
  • Ensure timely responses to the FDA
• Ensure contracts, budgets, etc. for regulatory affairs, clinical pharmacology & nonclinical development functions are developed/tracked
• Follow-up with CROs on contracted nonclinical development and clinical bioanalytical, PK, metabolism, transporter, etc. activities
• Perform other program leadership, regulatory operations and project coordination responsibilities as required for business needs.

Minimum required qualifications

• Advanced degree in a scientific discipline (PhD, MD, PharmD) with a minimum 12 years of related experience in pharmaceutical R&D program management with experience in the oncology therapeutic area.
• Good understanding or willingness to quickly learn oncology radiopharmaceuticals drug development processes and regulatory requirements.
• Excellent program management and leadership skillset with strong track record of accomplishments with strategic planning, tracking, and successfully supporting submission of IND filings and in advancing pharmaceutical R&D programs.
• Very good understanding of pharmaceutical R&D and business knowledge with an ability to innovatively address opportunities, evaluate alternatives, and establish priorities for project plans.
• Ability to think strategically and execute operationally.
• Strong communication, organizational, and interpersonal skills with keen attention to detail.
• Ability to motivate others, influence without authority, and negotiate conflict situations.
• Willingness to set, drive and take responsibility for aggressive project timelines.
• Proven ability to work collaboratively and effectively in a fast-paced, matrix organization and drive decision-making within cross-functional teams.
• Ability to collaboratively drive program-level decision-making within a cross-functional team structure.
• Demonstrated ability to clearly communicate key information to senior management and key stakeholders.
• Experience managing project-level budgets.
• PMP certification desirable.

Non-standard work schedule, travel or environmental requirements

• The position is based in San Diego, CA; a portion of the job duties may be performed remotely.

Compensation & Benefits
Radionetics has a competitive total compensation package that includes bonus opportunity; equity; medical, dental, vision, life, short-term, and long-term disability insurance; 401(k) retirement plan; 4 weeks of paid time off (PTO) annually; and generous paid holidays.

Pay Range: $250,000 - $295,000
Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California.

Important notices
Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class.

The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time.

Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics.

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