Senior Director Oncology

G&L Scientific; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

G&L Scientific is seeking an experienced oncology clinical development leader for an interim Director/Senior Director role. You will provide senior leadership across the programme, coordinating with Clinical, CMC and other development functions, and steer FDA interactions and IND activities.

The role requires hands-on leadership and the ability to navigate complex regulatory environments. You will mentor a development team of about 8–10 people, drive strategy for US and global development, and

Qualifications

• Director or Senior Director level experience in clinical development.
• Strong oncology drug development background.
• Experience with FDA interactions and IND/Phase 3 programmes.
• US regulatory expectations and global development exposure.

Responsibilities

• Provide senior clinical development leadership for an oncology programme across US and global development.
• Lead and support FDA interactions and IND submissions.
• Guide the programme into Phase 3 and potential regulatory approvals.
• Mentor and direct a development team of approximately 8–10 people.

Skills

Oncology CD leadership

Regulatory strategy

FDA interactions

Cross-functional leadership

IND submissions

Job description

We are looking for an experienced oncology clinical development leader to join an exciting development programme on an interim basis and make an immediate impact.

This is a key opportunity for a Director or Senior Director-level clinical development professional who is comfortable operating at a senior level, navigating complex regulatory environments and providing hands‑on leadership across an established cross-functional team.

The successful individual will play an important role in advancing an oncology programme through significant clinical and regulatory milestones, including FDA engagement, IND activities and Phase 3 development.

The Opportunity

You will provide senior clinical development leadership across the programme, working closely with colleagues across Clinical, CMC and other development functions.

This is a role for someone who can hit the ground running — bringing practical experience, sound judgement and confidence in dealing with regulatory and clinical development challenges, rather than requiring extensive onboarding.

Key areas of focus will include:

• Providing strategic clinical development leadership for an oncology programme, with the opportunity to contribute to US and global development strategy.
• Leading and supporting FDA interactions, including preparation of the development team and navigating different regulatory scenarios.
• Supporting IND submission activities and the transition into later‑stage development.
• Potentially leading the programme through regulatory interactions and into/through a Phase 3 study.
• Providing senior‑level guidance, mentorship and day‑to‑day direction to an established development team of approximately 8–10 people.
• Coaching and preparing more junior clinical development colleagues for agency interactions.
• Working closely with Clinical and CMC colleagues to ensure the programme is fully prepared for key development and regulatory milestones.
• Providing pragmatic, senior‑level input when navigating complex clinical, regulatory and cross‑functional situations.

What We're Looking For

We're keen to speak with experienced oncology clinical development professionals who can bring a combination of strategic thinking, regulatory expertise and hands‑on development experience.

Ideally, you will have:

• Director or Senior Director-level experience in clinical development.
• Strong experience in oncology drug development.
• Experience spanning early‑stage through later‑stage development, particularly Phase 3 and/or approval.
• Demonstrable experience leading or supporting FDA interactions.
• Experience with IND submissions and/or Phase 3 programmes.
• A strong understanding of US regulatory expectations.
• Global clinical development experience, ideally across multiple regions.
• The confidence to work independently and provide immediate leadership within an established team.
• A track record of coaching, mentoring and developing less experienced clinical development professionals.
• Strong cross‑functional collaboration skills, particularly across Clinical and CMC.

Global Strategy Lead for regulatory implementation.

May be the primary regulatory representative and responsible to their region in relation to overall project strategy including pre‑clinical and clinical (working with local RA where required).

Responsible for the Global regulatory strategy and ensuring alignment with Global commercial plans and priorities to optimize portfolio.

Accountable for identifying, assessing, and communicating regulatory risks, opportunities, and mitigation plans to senior leadership, enabling informed portfolio and development decisions.

Designs, coordinates, directs, and conducts all global regulatory interactions, including United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) interactions and other competent health authorities, leading preparation for agency meetings/interactions, health authority responses and labeling negotiations as appropriate.

Responsible for regulatory interactions, and submissions, including development of global regulatory submission strategies, integrated dossier planning, core prescribing information and strategic accountability for the regional filings while leveraging their GRT subject matter experts and endorsed by GRT.

Trains, acts as mentor and ensures proactive communication and knowledge sharing of strategic regulatory topics with GRT and other relevant stakeholders.

Acts as subject matter expert, as applicable.

Challenges and improves existing procedures.

Reviews relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance/legislation, as applicable, while leveraging GRT subject matter expertise.

Manages coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAS/BLAs) for their region, working in a global collaborative manner. Ensures timely follow up and execution according to agreed timelines.

Maintains expert knowledge of regional and global regulatory requirements, ICH guidance, regulatory precedents, and emerging health authority expectations along with familiarity with FDA/EMA/key international market regulations including Competitor intelligence/landscape.

Provides clear and valid regulatory guidance, interpretation by applying 'out of the box thinking' mindset, direction to GRT and region of responsibility.

Acts pro‑actively and sustains a good stakeholder collaboration within GRA via continuous stakeholder management.

Represents GRA according to delegated tasks.

Why This Role?

This is an opportunity to step into a high‑impact leadership position at a pivotal point in an oncology programme.

You’ll have the opportunity to use your experience where it matters most — helping shape development strategy, preparing for important FDA interactions and supporting the programme as it progresses towards later‑stage clinical development.

If you are an experienced oncology clinical development leader who enjoys complex programmes, senior stakeholder engagement and making an immediate difference, we’d be very interested in hearing from you.

NB: You can be based remotely in the US but there is a requirement to work within Eastern Time Zone