Full-Time

Global Asset Safety Lead

Ipsen Global

Ipsen Global

5,001-10,000 employees

Global biopharma focused on specialty care

No salary listed

London, UK + 1 more

More locations: Paris, France

Hybrid

Category
Biology & Biotech (1)
Required Skills
Risk Management
Requirements
  • Doctor of Medicine (MD)
  • Extensive clinical experience exercising medical judgment as a physician and several years of pharmacovigilance and/or clinical development experience
  • Experience in leading cross-functional Global Product Teams, Safety Teams and Clinical Development Teams
  • Knowledge of product development processes and experience of cross-functional teamwork
  • Working knowledge of pharmacovigilance legislations worldwide
  • Competent team player with excellent networking and influencing skills
  • Ability to prioritise own workload, work under pressure and achieve strict timeline targets
  • Problem-solving approach – solution and results-orientated
  • Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
  • Fluency in English
Responsibilities
  • Provide leadership and expert safety oversight as a key member of the cross-functional Asset Team.
  • Support clinical development of the product by leading the delivery of safety driven activities across the full development programme - from FIH studies through to regulatory submission – in close collaboration with cross-functional Asset Team members.
  • Accountable for the conduct of safety surveillance and assessment of integrated safety information, to ensure the timely proposal of changes to the safety profile and appropriate risk management and risk minimisation actions, in order to warrant the safe and effective use of Ipsen products in development projects and on the market.
  • Actively contribute to the cross-functional working groups as the representative safety expert to ensure these considerations are taken into account during the clinical development of the product.
  • Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met.
  • Implement proactive safety and risk management strategies, agreed cross-functionally with asset team colleagues for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions.
  • Clearly communicate and distil complex safety data into meaningful insights for decision-makers.
  • Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy for approval by safety governance.
  • Lead the development of the Risk Management Plan for assigned products as applicable.
  • Chair the PST/BRT if the Asset Safety Lead is unavailable, support B/R assessments and ensure the evaluation of the effectiveness of risk minimisation measures.
  • Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available evidence.
  • Provide safety expertise, strategies and leadership to the global filing teams for all components of regulatory submissions, health authority questions, and periodic safety reports (PSURs, PBRERs, DSURs).
  • Deliver medical safety assessments as required, e.g. in the evaluation of the risk and impact of product quality complaints.
  • Ensure that the respective GPS Stakeholder Leads, and thereby Ipsen senior management, are kept informed of any new data that might impact the benefit-risk of Ipsen products, working in collaboration with the Asset Safety Lead.

Ipsen is a global biopharmaceutical company that concentrates on specialty care, developing and marketing medicines for oncology, neuroscience, and rare diseases. Its products work by treating specific high-need conditions, ranging from historical diarrhea treatment Smecta to modern targeted therapies in cancer and neurological disorders. The company differentiates itself through a focused portfolio in niche therapeutic areas, growth via strategic acquisitions, and a long-standing family heritage that shaped its international expansion and IPO-driven capital for expansion. Its goal is to address unmet medical needs worldwide by providing effective therapies for patients with serious or rare conditions.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Boulogne-Billancourt, France

Founded

2005

Simplify Jobs

Simplify's Take

What believers are saying

  • IPN01203 T cell activator advances in Phase I/II targeting Vβ6/Vβ10 for solid tumors.
  • IPN60300 ADC targets novel ITGA2 antigen overexpressed in pancreatic and gastric cancers.
  • ImCheck Therapeutics acquisition valued up to EUR 1 billion bolsters immuno-oncology pipeline.

What critics are saying

  • ImCheck EUR 1 billion acquisition overextends balance sheet post €500M bond in March 2025.
  • IPN01203 Phase I/II trials fail anti-tumor activity in pancreatic cancer within 12 months.
  • Merck KGaA captures Ojemda market share in pediatric glioma within 18 months.

What makes Ipsen Global unique

  • Ipsen focuses exclusively on oncology, rare diseases, and neuroscience therapeutic areas.
  • Mid-sized agility enables rapid commercialization in 88 countries with 5,000 employees.
  • Ojemda gains EU approval as first targeted therapy for pediatric low-grade glioma in 2026.

Help us improve and share your feedback! Did you find this helpful?

Your Connections

People at Ipsen Global who can refer or advise you

Benefits

Wellness Program

Flexible Work Hours

Hybrid Work Options

Remote Work Options

Paid Vacation

Company News

MarketScreener
Apr 7th, 2026
Beech Tree wins AMF waiver exempting it from mandatory takeover bid for 26% Ipsen stake

French pharmaceutical company Ipsen has announced that Beech Tree, which holds a 26.03% stake in the company's capital and 33.05% of voting rights, has received a waiver from the French Financial Markets Authority exempting it from filing a mandatory public tender offer. The waiver follows the transfer of Henri Beaufour's stake in Beech Tree to the Alasol Foundation. The transaction includes a governance agreement between Altawin, the Alasol Foundation and Beech Tree. Under the agreement, the Alasol Foundation has committed to holding its Beech Tree shares for at least 15 years and will not interfere in Beech Tree's management of its Ipsen stake. The agreement also establishes Altawin's veto rights and ensures continuity with the strategic direction set during Beaufour's lifetime.

Chinook Observer
Mar 18th, 2026
Ipsen showcases transformative potential of early immuno-oncology pipeline at AACR.

Ipsen showcases transformative potential of early immuno-oncology pipeline at AACR. GlobeNewswire | Ipsen Pharma Yesterday at 11:00pm PDT * IPN01203 data to be presented at coveted New Drugs on the Horizon program session, demonstrating early potential of this novel T cell activator to transform care in solid tumors * ITGA2 revealed as novel target of Ipsen's investigational antibody drug conjugate IPN60300, over-expressed across numerous solid tumor types * Preclinical data show potential of Ipsen's growing collection of investigational medicines, leveraging precision immuno-modulation to deliver differentiated anti-tumor activity PARIS, FRANCE, 18 March 2026 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today the presentation of new preclinical data across multiple early development programs currently in Phase I clinical trials, at the American Association of Cancer Research (AACR) congress. These latest data include an oral presentation for T cell activator (TCA) IPN01203 to be presented during the coveted New Drugs on the Horizon program session, highlighting the differentiated mode of action, activating Vβ6/Vβ10 T cells. These latest preclinical data will expand the growing evidence base, reinforcing the first-in-class potential of IPN01203 to improve outcomes where there are significant unmet needs for people living with solid tumors. Additionally, Ipsen revealed ITGA2 as the novel target for innovative antibody-drug conjugate (ADC) IPN60300, now in active Phase I evaluation. Preclinical findings showed pronounced over-expression of ITGA2 across multiple solid tumors - including pancreatic, gastric and colorectal cancers - with clear differential expression when compared to normal tissues. These results confirmed that IPN60300 binds specifically and with high affinity to ITGA2, enabling efficient internalization and accumulation of the exatecan payload. Further preclinical tumor model data showed dose-dependent anti-tumor activity and favorable tolerability, suggesting a promising first-in-class therapy with the potential to improve clinical outcomes. "These data presented at AACR exemplify our approach to early science, showcasing how we are harnessing precision immuno-modulation backed by the strength of preclinical data to advance next generation therapies where there are the highest unmet needs," said Mary Jane Hinrichs, SVP Early Development, Ipsen. "It's a privilege to see the growing transformative potential of these new modalities, paving the way for potential best- and first-in-class impact for people living with cancer." Underscoring the strength and promise of Ipsen's precision medicine approach, IPN01203 and IPN60300 combine precision targeting with innovative mechanisms of action with the aim of delivering strength of efficacy where few other treatments exist. About IPN01203 IPN01203 is a first-in-class T cell activator which selectively activates a group of Vβ6 T cells through the TCR and IL-15R pathways, enhancing their ability to recognize and target tumors. IPN01203 was generated by Marengo's Selective T Cell Activation Repertoire (STAR) platform, a multi-specific fusion protein library that targets specific TCR Vβ variants fused to different co-stimulate moieties to develop potent T cell activators. A Phase I/II dose escalation and expansion trial is ongoing. About IPN60300 IPN60300 is a first-in-class antibody-drug conjugate targeting the novel tumor antigen ITGA2 known to be overexpressed in many solid tumors, including pancreatic, gastric and colorectal cancers. This novel tumor antigen was identified using Foreseen' Biotechnology's high throughput, integrated translational proteomics, and artificial intelligence (AI)-powered screening platforms. Comprised of an ITGA2-targeting antibody, exatecan payload and innovative linker from Escugen Biotechnology's EZWi-Fit(TM), IPN60300 is optimally designed to allow for a wide therapeutic index, with potential for improved efficacy over standard of care as well as a favorable safety profile. A Phase I/II dose escalation and expansion trial is ongoing. About Ipsen Chinook Observer is a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Its pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Its teams in more than 40 countries and its partnerships around the world enable Chinook Observer to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. | Ipsen Contacts | / | / | | Investors | / | / | | Henry Wheeler | [email protected] | +33 7 66 47 11 49 | | Khalid Deojee | [email protected] | +33 6 66 01 95 26 | | Media | / | / | | Sally Bain | [email protected] | +1 857 320 0517 | | Anne Liontas | [email protected] | +33 7 67 34 72 96 | | / | / | / | Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on ipsen.com. This is a paid placement. For further inquiries, please contact GlobeNewswire directly.

EQT Group
Oct 22nd, 2025
EQT Life Sciences’ ImCheck Therapeutics to be acquired by Ipsen in a transaction valued at up to EUR 1 billion

· Ipsen and ImCheck Therapeutics have entered into a definitive share purchase agreement. ImCheck’s shareholders will be eligible to receive a payment of EUR 350 million and downstream payments,  for a total potential consideration of up to EUR 1 billion. · ImCheck Therapeutics is a private French biotechnology company pioneering next-generation immuno-oncology therapies. · EQT Life Sciences has backed ImCheck since 2017 and has provided comprehensive support beyond capital, at the board level.

GlobeNewswire
Mar 19th, 2025
Ipsen announces issuance of €500 million inaugural Rated Public Bond

Transaction follows Investment Grade ratings assignment from both S&P and Moody’s PARIS, FRANCE, 19 March 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a...

Business Wire
Jun 9th, 2023
BAKX Raises $25 Million to Develop Therapeutics Targeting Pro-Apoptotic Proteins and Mitochondrial Apoptosis Pathway

BAKX Therapeutics today announced it closed $25 million in a Series A fundraising led by AB Magnitude Ventures Group with Ipsen Pharma SA and Sherpa H