Head of Clinical Operations

AKIGAI; Oslo fylke; Vor Ort; NOK 1.800.000 - 2.400.000; Vollzeit

Benefits dieser Stelle

Share option program

Autonomy and room for creativity

Base in Oslo

Collaboration with founders

Zusammenfassung

AKIGAI, headquartered in Oslo, is seeking a Head of Clinical Operations to lead execution across our neuropathic pain programs. This senior role shapes strategy, budgets, vendor relationships, and cross-functional alignment to deliver Phase 2b/3 trials and EU initiatives.

You will drive end-to-end trial planning, CRO management, regulatory readiness, and data integrity while building a lean, high-performance operations team. Fluency in English is required; Norwegian is a plus.

Qualifikationen

• Bachelor's degree required; advanced degree preferred.
• 5+ years of clinical operations experience in biotech/pharma.
• Direct experience leading at least one Phase 2 trial through startup to database lock.
• Deep working knowledge of ICH-GCP.
• Proven track record managing CROs and vendors, including contract negotiation and oversight.
• Experience building and scaling a clinical operations function in lean small-company settings.
• Fluent in English (Norwegian a plus, not required).

Aufgaben

• Own end-to-end operational delivery of trial programs with timelines, budget, medical, quality, regulatory, drug supply and risk management.
• Coordinate site and vendor activities, including contracting and negotiations.
• Prioritize and sequence resources and timelines across the portfolio.
• Help operationalize the EU Early Access program (EAP) and manage vendor relations.
• Establish and monitor KPIs/metrics with CROs and vendors; drive accountability to timelines and quality standards.
• Partner with Regulatory Affairs, CMC, Clinical and Data Management on data flow and submission readiness.

Kenntnisse

Clinical operations

Leadership

Cross-functional collaboration

Regulatory compliance

Vendor management

Strategic planning

Communication

Ausbildung

Bachelor's degree

Advanced degree (MD, MS, PhD, PharmD, RN) preferred

Tools

EDC

CTMS

eTMF

IRT/RTSM

Jobbeschreibung

Head of Clinical Operations – AKIGAI AS, Oslo

Neuropathic Pain Portfolio — Phase 2b/3, Phase 2 Basket Trials, Academic Collaboration & EU Early Access

AKIGAI is looking for a Head of Clinical Operations

Location: Oslo, Norway

Employment type: Full-time

AKIGAI aims to change the lives of people living with neuropathic pain. Our mission is to bring an EGFR-inhibitor for the treatment of neuropathic pain to as many patients as possible, as fast as possible.

Our founders are oncologists who, through a chance observation, found that EGFR-inhibitors can relieve neuropathic pain. More than a decade of clinical experience later, AKIGAI is developing this approach into a new, non-opioid treatment for the millions of patients with neuropathic pain who need better options.

Our lead program, AKI-007 (SEARPS™), is a low-dose reformulation of an existing cancer drug.Its development will start in complex regional pain syndrome (CRPS), a rare condition with no approved drug treatment. AKIGAI holds orphan drug designation for CRPS in the US and EU. Following recent FDA clearance of our IND, a Phase 2b/3 trial in CRPS will start at eight US sites in early 2027. In parallel, we are preparing a European early access program and further Phase 2 trials in neuropathic pain, as well as developing a second-generation anti-EGFR antibody.

The Role

We are seeking an experienced Head of Clinical Operations to lead execution of our clinical development portfolio in neuropathic pain. This senior leadership role is responsible for building and running the clinical operations function across a multi-program portfolio spanning our US Phase 2b/3 trial, potentially two Phase 2 basket trials (including a pediatric CRPS/neuropathic pain program), an academic trial in neuropathic cancer pain, and a European Early Access Program.

You will execute operational strategy in close collaboration with our entire team, budget, vendor relationships, and cross-functional execution across this portfolio, and will be a key voice in executing our Clinical Development.

This role suits someone with an entrepreneurial can-do attitude, but who also has taken at least one program through a phase 2 or preferable a pivotal trial in a small-to-mid-size biotech, is comfortable operating with lean internal teams and heavy CRO reliance, has preferably run multi-center trials, and can move fluidly between program strategy and hands-on problem solving.

Program Portfolio

The Head of Clinical Operations will oversee the following concurrent programs, each with distinct operational demands:

Starting in 1Q2027:

• Pivotal Phase 2b/3 trial —the company's primary registrational program
• European Early Access Program across relevant EU markets ahead of full approval

Planning stage:

• Phase 2 pediatric basket trial — neuropathic pain and CRPS in children
• Academic Phase 2 trial — neuropathic cancer pain, run by an academic group
• Phase 2 basket trial (adult) — neuropathic pain across multiple etiologies under a shared master protocol

Key Responsibilities

Trial Planning & Execution

• Own and coordinate end-to-end operational delivery of the trial program, including timelines, budget, medical, quality, regulatory, drug supply and risk management
• Coordinate site and vendor activities, including involvement in contracting and negotiations
• Prioritize and sequence resources and timelines across the concurrent portfolio

European Early Access Program

• Help to operationalize the EU Early Access program (EAP)
• Help to manage EAP vendor(s)/distribution partners, physician requests, drug supply logistics, and safety reporting for enrolled patients
• Coordinate with drug supply and regulatory to ensure EAP design

Vendor & CRO Management

• Coordinate CRO selection and oversight; act as primary operational escalation point
• Manage relationships with IRT/RTSM, ePRO/eCOA, and specialty vendors
• Establish and monitor KPIs/metrics with CROs and vendors; drive accountability against timelines and quality standards

Budget & Resourcing

• Support the clinical operations budget; manage forecasting, accruals, and vendor invoicing in partnership with Finance

Quality, Compliance & Inspection Readiness

• Ensure trial conduct complies with ICH-GCP, regulatory agencies plus company SOPs
• Partner with Medical, QA and Regulatory on audit and inspection readiness (sponsor and site level)
• Own CAPA processes related to clinical operations findings

Cross-Functional Leadership

• Partner with Regulatory Affairs on submission-enabling data package timelines
• Partner with CMC on drug logistics
• Partner with Clinical and Data Management on data flow, cleaning timelines, and database lock readiness
• Communicate program status, risks, and mitigation plans clearly to executive leadership

Required Qualifications

• Bachelor's degree required; advanced degree (MD, MS, PhD, PharmD, RN) preferred
• 5+ years of clinical operations experience in biotech/pharma
• Direct experience leading or co-leading at least one Phase 2 trial from start-up through database lock
• Deep working knowledge of ICH-GCP
• Proven track record managing CROs and vendors, including contract negotiation and performance oversight
• Experience building and scaling a clinical operations function, including in small-company settings with lean staffing
• Fluent in English (Norwegian a plus, not required)

Preferred Qualifications

• Prior experience in a company that scaled from early-phase to late-stage/commercial-ready operations
• Familiarity with clinical systems (EDC, CTMS, eTMF, IRT/RTSM) and data-driven trial oversight
• Experience designing or operating an EAP

What Success Looks Like in Year One

• You have become part of an enthusiastic team and exhibit a “can-do” attitude
• Program timelines and enrollment targets across the portfolio are met, or actively and transparently managed against risk
• A capable clinical operations team and CRO governance structure are in place and functioning across all programs
• The EAP is live with clear processes for physician requests, supply, and safety reporting
• Inspection-ready trial conduct and documentation across active sites and programs
• Clear, trusted operational reporting to executive leadership and the board across the full portfolio

AKIGAI offers

• A journey where you help create activities that can change the lives of millions of people.
• Work you have never done before, in a company taking a first-in-class therapy towards approval.
• Autonomy and room for creativity.
• Close collaboration with the founders and an international network of pain experts.
• Participation in the company's share option program.
• A base in Oslo.