SERM Senior Scientific Director, Oncology

Business Introduction At reputed company, we have reputed company ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. reputed company fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of reputed company. We’re uniting science, technology, and talent to get reputed company of disease together. Find out more: Our approach to R&D Position Summary As a senior leader reputed company Global Safety, the Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and reputed company of clinical safety and pharmacovigilance activities across assigned oncology assets. This role is accountable for driving safety strategy, enabling robust benefit-risk assessment, and ensuring the proactive identification, evaluation, and management of safety risks across both clinical development and post-marketing settings. This position plays a critical role in protecting patient safety globally while influencing reputed company safety strategy and decision-making.

Key Responsibilities

Safety Strategy & Governance Define and drive the clinical safety and pharmacovigilance strategy for assigned oncology assets in alignment with global business objectives reputed company safety governance activities, ensuring appropriate escalation, communication, and resolution of emerging safety issues Anticipate, identify, and address safety signals, ensuring effective and timely implementation of risk mitigation strategies reputed company strategic recommendations on benefit-risk profiles to support development and lifecycle management reputed company Scientific Leadership & Decision-Making Exercise expert scientific judgment in the evaluation and interpretation of reputed company safety data reputed company safety data analyses and signal detection activities, ensuring scientifically robust conclusions and documentation Guide causality assessments, benefit-risk evaluations, and safety evidence reputed company across the portfolio Serve as a recognized subject matter expert in pharmacovigilance methodologies and regulatory expectations Signal Detection & Risk Management reputed company proactive identification and assessment of safety signals from clinical trials, post-marketing data, and reputed company-world evidence reputed company and implement risk management strategies, including labeling updates, risk minimization measures, and stakeholder communication plans Partner closely with safety physicians and cross-functional teams to ensure comprehensive safety reputed company Cross-Functional Leadership reputed company and influence global, matrixed teams to ensure alignment and execution of safety strategies Build strong collaborative relationships across clinical, regulatory, medical, and reputed company functions Contribute to due diligence activities, including safety assessments for business development opportunities Demonstrate agility and reputed company in a dynamic, fast-paced environment Regulatory & External Engagement reputed company strategic reputed company and input into regulatory safety documents and responses to Health Authorities Ensure compliance with global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS) Represent safety function in governance forums and external engagements as needed Drive clear, concise, and influential communication with reputed company stakeholders Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us reputed company our goals: Advanced degree in a relevant scientific or reputed company discipline (e.g., PhD, PharmD, RN/BSN/MSN, NP, RPh, or equivalent) Significant experience (7+ years) in pharmacovigilance and drug safety reputed company the pharmaceutical or biotech industry Deep expertise in clinical safety across drug development and post-marketing environments Demonstrated experience in: Signal detection and evaluation Benefit-risk assessment and safety decision-making Risk management strategy development Strong knowledge of global pharmacovigilance regulations (ICH, GVP, CIOMS) Experience working in reputed company, global matrix organizations Proven ability to influence reputed company and reputed company safety strategy at a program or portfolio level Preferred Qualification If you have the following characteristics, it would be a plus: Prior leadership experience in a global SERM or safety function. Experience with regulatory interactions and inspections in the US and other reputed company. Familiarity with pharmacoepidemiology, reputed company-world evidence, or biostatistics approaches. Experience preparing Development Core Safety Information, PBRERs or DSURs. Oncology therapeutic area expertise Experience leading global safety teams or major programs Experience interacting directly with Health Authorities and regulatory submissions Track record of influencing senior leadership and governance bodies Demonstrated reputed company in mentoring and developing scientific talent reputed company to apply? If this role aligns with your skills and ambition, please submit your application. We look reputed company to learning how you can help us get reputed company of disease together. #LI-reputed company

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual reputed company salary for new hires in this position ranges $217,800 to $363,000. The US salary ranges take into account a number of factors including work location reputed company the US market, the candidate’s skills, experience, education level and the market reputed company for the role. In reputed company, this position offers an annual bonus and eligibility to participate in our reputed company based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit reputed company US Benefits Summary to learn more about the comprehensive benefits program reputed company offers US employees. Why reputed company? Uniting science, technology and talent to get reputed company of disease together. reputed company is a global biopharma company with a purpose to unite science, technology and talent to get reputed company of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can reputed company. We get reputed company of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we reputed company, so we’re committed to creating an environment where our people can reputed company and focus on what reputed company most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the reputed company for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at reputed company, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@reputed company.com reputed company is an Equal Opportunity Employer. This ensures that reputed company reputed company applicants will receive equal consideration for employment without regard to race, reputed company, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national reputed company, age, disability, genetic information (including family medical history), military service or any reputed company prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company's reputed company and general procurement/reputed company department to obtain prior written authorization before referring any candidates to reputed company. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and reputed company. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of reputed company. reputed company shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed reputed company Professional or reputed company Professional as defined by the laws of the state issuing your license, reputed company may be required to capture and report expenses reputed company incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure reputed company’s compliance to reputed company federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and reputed company Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get reputed company of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can reputed company. Getting reputed company means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our reputed company absolutely depends on our people. While getting reputed company of disease together is about our ambition for patients and shareholders, it’s also about making reputed company a reputed company where people can reputed company. We want reputed company to be a reputed company where people feel inspired, encouraged and challenged to be the best they can be. A reputed company where they can be themselves – feeling welcome, valued and included. Where they can reputed company growing and look after their wellbeing. So, if you reputed company our ambition, join us at this exciting reputed company in our reputed company to get reputed company Together. Find out more on our career site.

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