Criminal investigator Jobs in Orange, CA

Director, Early Development - Clinical Sciences

Irvine, California, United States

The Director, Early Development - Clinical Sciences will create early development clinical plans, program outlines, study designs and clinical study essential documents. This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team and investigator meetings as needed.

This role will collaborate closely with cross-functional teams such as Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance and Legal to drive efficient and scientifically rigorous early development clinical work.

Let's talk about some of the key responsibilities of the role:

• Maintains direct ownership of early development clinical deliverables, actively contributing to protocol development, document authoring, data review, study-level problem solving and execution decisions to ensure scientific rigor and operational excellence.
• Shape clinical plans including timelines, budgets and oversight of clinical teams.
• Author and critically review key clinical and regulatory documents, including protocols, SAPs, CSRs, IBs and clinical value dossiers, ensuring scientific rigor, regulatory alignment and quality execution.
• Lead and oversees the training of study investigators on protocol and on clinical trial procedures.
• Conduct research to develop foundational education material to inform the early development program strategies.
• Interpret clinical data and support data-driven decisions.
• Serve as program lead on early development Core teams, investigator meetings and scientific advisory boards.
• Engage with internal and external stakeholders, including KOLs and regulators.
• Exhibits and fosters key leadership competencies, including an innovative mindset, strong business acumen, an outcome-driven orientation, and a commitment to growing and expanding the capabilities and capacity of the team.
• Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs and others to ensure robust trial design, scientific and operational alignment and execution.

Factors for Success:

• Advanced degree in sciences (e.g. PharmD, MD, PhD) with deep experience in early clinical development
• Experience in ophthalmology is preferred; dermatology or infectious diseases a plus.
• Minimum of 10 years of biotech/pharmaceutical clinical development experience, with a minimum of 8 years leadership in clinical trial management experience required
• Established leadership track record with evidence of excellent performance-based people management experience, problem solving, collaboration, cross functional leadership and effective communication skills.
• Expertise with SOPs, GCPs and regulatory and compliance guidelines for clinical trials.
• Must be willing to be "hands on" and delve into details

Leadership Competencies - This role requires mastery of the Tarsus Leadership Competencies for Leading People, including:

• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
• Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders' decision-making capability, and creating systems that support performance and growth.
• Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure.

Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our SVP, Development
• Some travel may be required up to 30%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $203,200 - $284,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.