Senior Medical Director - Late Stage
About the job
- M.D. or equivalent international medical degree (MBBS or MBChB), with board certification or eligibility in Oncology or Hematology-Oncology; subspecialty training in thoracic malignancies is strongly preferred.
- At least 13 years of experience in clinical development; Pharma R&D experience outside a clinical-development role may be considered based on transferable skills and responsibilities.
- At least 5 years of late-stage clinical development experience within the biotechnology or pharmaceutical industry.
- Demonstrated experience with medical data review and data cleaning for NDA or BLA filings and regulatory submissions.
- Strong working knowledge of data cleaning, database-lock processes, and clinical data review.
- Ability to lead cross-functional clinical teams and contribute to strategic development plans.
- Written and verbal communication skills for scientific and regulatory audiences.
- Extensive experience applying data-analysis and interpretation principles and techniques, including clinical relevance, in the pharmaceutical or biotechnology industry.
- Experience independently generating trial designs; writing or amending protocols and informed consent forms; constructing appropriate case report forms; and coordinating cross-functionally.
- In-depth therapeutic-area expertise and relevant clinical-trial experience, or clear ability to adapt using transferable skills.
- Strong knowledge of medical aspects of Good Clinical Practice, International Council for Harmonisation guidelines, and relevant Food and Drug Administration, European Medicines Agency, and other guidelines and regulations.
- Ability to work effectively and efficiently within cross-functional drug-development teams and integrate multiple perspectives into the Clinical Development Plan.
- Experience authoring regulatory briefing packs, writing responses to Health Authority questions, and contributing to strategic approaches and cross-functional coordination for regulatory activities and interactions.
- Demonstrated success driving cross-functional study-level strategy, including study design, feasibility, timeline and budget projections, and protocol amendments; ability to drive relevant discussions at internal decision-making bodies and governance forums.
- Ability to build and maintain relationships and contribute to interactions with external key opinion leaders to optimize clinical programs, including advisory boards, individual engagements, and steering committees.
- Experience engaging investigators to optimize clinical-trial conduct, including presenting at investigator meetings.
- Ability to mentor team members; experience or clear potential as an effective line manager.
- Ability to build and maintain relationships with internal and external stakeholders.
- Strategic thinking and analytical skills to make data-driven decisions, assess trade-offs, and determine priorities and goals.
- Written communication and business-presentation skills.
- Ability to anticipate needs and assess and manage business and organizational risks.
- Ability to work in a fast-paced, collaborative biotechnology environment.
- Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio.
- Apply medical expertise to guide query resolution, outlier adjudication, and clinical-plausibility review during data cleaning.
- Collaborate with clinical study teams to align protocol design, case report forms, and data standards with downstream regulatory submission requirements.
- Lead clinical-science aspects of the Clinical Development Plan strategy and clinical documentation.
- Represent the Clinical Development Plan on appropriate teams, sub-teams, and forums; oversee training of study-site personnel; act as the primary point of contact for program-level Clinical Development Plan questions; and oversee medical and safety data reviews and study reporting.
- Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet Food and Drug Administration, European Medicines Agency, and International Council for Harmonisation standards for NDA, BLA, and MAA filings.
- Support the Medical Monitors Medical Lead and other team leads with clinical sections of regulatory dossiers, including Integrated Summary of Efficacy, Integrated Summary of Safety, and Clinical Study Reports.
- Support preparation of responses to regulatory authorities and contribute to advisory committee briefing documents.
- Drive end-to-end data-cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data.
- Lead clinical-data-review meetings, escalate issues, and recommend solutions to maintain data reliability and consistency.
- Take potential assignments to complex, high-priority strategic studies and perform responsibilities independently with self-directed leadership.
- Work with Data Management, Medical Monitors, contract research organizations, and Clinical Operations to ensure site-level data collection, query resolution, and other activities align with submission requirements.
- Partner with Pharmacovigilance to reconcile safety databases with clinical-trial datasets.
- Align work cross-functionally with scientific, regulatory, and commercial objectives while executing the Clinical Development Plan.
- Lead and mentor a cross-functional team of clinical-development professionals.
- Oversee clinical-trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.
- Establish and maintain relationships with clinical investigators, regulatory agencies, and key stakeholders.
- Gather, analyze, and interpret clinical data; provide strategic insights to inform decisions and guide program development.
- Manage clinical-development timelines, resource allocation, and milestone achievement.
- Monitor scientific advancements and regulatory trends in clinical development.
- Subspecialty training in thoracic malignancies.
- Experience enhancing or developing core and sub-team processes, structures, systems, tools, and other resources in the pharmaceutical or biotechnology industry.
- Experience leading clinical-development contributions to major regulatory submissions, such as NDA, BLA, PIP, or PSP submissions; label negotiations; Breakthrough Therapy Designation; or accelerated review.
- Ability to present a program’s clinical-development aspects to major health authorities, including the Food and Drug Administration and European Medicines Agency, by teleconference or in person; experience leading Health Authority interactions.
- Ability to set the clinical-development strategy for CTA or EC submissions and responses to Health Authority questions.
- Experience collaborating on enterprise-level strategic initiatives with internal and external partners and stakeholders, including clinical investigators, clinicians, scientists, key opinion leaders, development, research, business development, commercial, and legal groups, to achieve strategic outcomes.
- Ability to influence and inspire teams and individuals.
- Demonstrated courage and conviction and conflict-resolution skills.
About the company
Revolution Medicines develops targeted therapies for cancers caused by RAS mutations, which are found in about 30% of human cancers. The company’s products are small molecules called RAS(ON) inhibitors that work by blocking the active, cancer-promoting form of the RAS protein to stop tumor growth. Unlike older treatments that could only target a few specific mutations, this platform creates inhibitors that can address a much wider range of RAS-driven cancers. The company's goal is to advance these candidates through clinical trials to provide effective treatment options for patients with previously "undruggable" forms of cancer.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Redwood City, California
Founded
2014
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Simplify's Take
What believers are saying
- FDA approved RASONQUE on August 26, 2026, six months ahead of deadline.
- RASolute 302 cut death risk 60% and doubled median overall survival to 13.2 months.
- Royalty Pharma's June 2025 $2 billion package funds commercialization and global expansion through 2027.
What critics are saying
- RASONQUE costs $39,800 monthly, inviting Medicare and commercial payer restrictions in 2026.
- Revenue still depends overwhelmingly on one launch; any RASONQUE setback crushes the company.
- AstraZeneca, Amgen, and Mirati pressure RAS programs; resistance or safety issues can erase the franchise.
What makes Revolution Medicines unique
- RASONQUE became the first approved broad RAS(ON) inhibitor on August 26, 2026.
- Revolution Medicines avoids companion diagnostics and treats metastatic PDAC with or without RAS mutations.
- Its pipeline spans daraxonrasib, elironrasib, and zoldonrasib across pancreatic, lung, and colorectal cancers.
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↓ -2%This pill will change cancer treatment forever. Revolution Medicines' daraxonrasib is the first drug that can broadly tackle one of the main drivers of pancreatic cancer. By Ed Cara Published September 30, 2026, 7:08 am ET Reading time 4 minutes Revolution Medicines is the winner of the 2026 Gizmodo Science Fair for its research and development of Rasonque (daraxonrasib), the first approved cancer drug of its kind. The question. Can we find an effective and reliable treatment for pancreatic cancer, which currently only has a five-year survival rate of 13%? The results. In a large-scale clinical trial of 500 people with metastatic pancreatic ductal adenocarcinoma (the most common form of pancreatic cancer), people on daraxonrasib lived twice as long as those on standard chemotherapy: 13.2 months median survival compared to 6.7 months. The treatment group also lived longer without progression of their cancer, and the drug was relatively well-tolerated, with only about 1% discontinuing the drug. In late August, the Food and Drug Administration approved Rasonque for people with pancreatic ductal adenocarcinoma who have already tried at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Why they did it. RevMed originally began in 2014 as a natural product chemistry company focused on finding novel treatments for infections, according to Jan Smith, RevMed's chief scientific officer. After its early efforts failed to take off, however, the company made a pivotal decision to move into oncology, Smith said, "recognizing that cancer represented one of the most meaningful opportunities to make a difference for patients." Like many scientific discoveries, RevMed researchers didn't purposefully set out to develop drugs like daraxonrasib. They began working on a drug candidate designed to inhibit SHP2, an enzyme that transmits growth signals from outside a cancer cell to a pathway inside the cell governed by RAS, a family of proteins that many in the field had considered impossible to directly target with drugs. To their surprise, their candidate could actually shrink tumors fueled by mutations of RAS, something that wasn't supposed to happen. "This observation led us to the realization that we had 'a tiger by the tail' and needed to go after RAS itself," Smith said. "Despite RAS being the first genetic driver of human cancer ever discovered, RAS-driven cancers have defied targeted treatment approaches for decades, making RAS truly the holy grail target of oncology." Daraxonrasib is specifically the first approved medication in a class of drugs known as RAS(ON) inhibitors. RAS acts as a sort of switch for cell growth, and cancer-fueling RAS mutations force the protein to be stuck in its active "ON" state, driving further growth. Daraxonrasib and similar agents bind to and block activity from mutant RAS proteins left in this state. "These inhibitors harness a naturally occurring protein in cells to create a complex with a precisely engineered, large surface area that establishes a molecular foothold on the smooth, featureless surface of RAS(ON), enabling direct inhibition of RAS in its oncogenic state," explained Smith. Why they're a winner. It's hard to oversell just how earthshaking RevMed's breakthrough is. Scientists have made great strides in treating many different kinds of cancer, with the notable exception of pancreatic cancer. We're even less equipped to handle metastatic pancreatic cancer, which currently has a five-year survival rate of 3%. However, the vast majority of pancreatic cancers, around 90%, are fueled by RAS mutations. And though daraxonrasib isn't the first approved drug that targets RAS, it is the first that attacks a broad range of RAS mutations, which should allow it to target much of that 90% slice. Right now, the drug is only meant for cases that haven't responded to other treatments, but RevMed has already launched a phase III trial testing it as a frontline drug for metastatic pancreatic ductal adenocarcinoma. To be clear, daraxonrasib is not a cure. Some people don't respond to the drug initially, and even when they do, their cancers can often still adapt to the treatment over time and find ways to keep growing. But daraxonrasib will give doctors and patients the first real fighting chance they've had against pancreatic cancer, and it's likely only the start of a new era. What's next. RevMed has eight phase III trials that it has either completed, is actively carrying out, or plans to launch by the end of 2026, and its researchers are working to deepen their pipeline. Though daraxonrasib is a broad-reaching inhibitor, the company is also developing other candidates that more narrowly go after specific RAS mutations. "We're progressing both multi- and mutant-selective approaches to explore new potential treatment options for RAS-driven cancers," Smith said. Further down the line, the company is hoping to pioneer drugs that can counteract a cancer's resistance to RAS-targeted therapies. Notably, pancreatic cancer isn't the only type often driven by RAS mutations; up to 50% of colorectal cancers involve these mutations, as do around a third of lung adenocarcinomas. Several of the company's trials are testing drugs for non-small cell lung cancers as well as solid tumors associated with RAS. The team. It's taken plenty of resources and teamwork for RevMed to reach the top of the mountain. One critical aspect of its success was the acquisition of the company Warp Drive Bio in 2018, which pioneered the tri-complex inhibitor platform that eventually made daraxonrasib a reality. "This research has required collaboration across multiple disciplines and organizations. Our internal team spans deep expertise in chemical biology, cancer biology, structure-based and computationally assisted drug discovery, medicinal chemistry, pharmacology, translational research and clinical oncology," Smith said. And of course, none of this would be possible without the many cancer patients who volunteered their time and bodies. As of now, the company has treated more than 2,500 people with one or more of its RAS(ON) inhibitors. And because of them, the roughly 67,000 Americans diagnosed annually with pancreatic cancer now have more hope than ever.
Revolution Medicines received FDA approval for daraxonrasib, the first targeted therapy for metastatic pancreatic cancer, after clinical data showed it reduced death risk by more than half. The company is clinical-stage with no current revenue and posted a $1.1 billion net loss in FY 2025. Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. Free cash flow reached $8.1 billion. The company carries a debt-to-equity ratio of 6.3x. Revolution Medicines maintains a 0.1x debt-to-equity ratio and 9.5x current ratio but recorded negative free cash flow of $913.7 million. The company's pipeline targets RAS-driven tumours including lung cancer. A partnership with Royalty Pharma provides funding for development. Both companies face distinct risks: Amgen confronts pricing pressures and biosimilar competition, whilst Revolution Medicines carries clinical trial failure risks and competes against larger pharmaceutical firms.
The US Food and Drug Administration approved Rasonque (daraxonrasib), a once-daily pill from Revolution Medicines, for adults with metastatic pancreatic cancer who have had chemotherapy. It is the first broad RAS-targeted medicine cleared for this indication. Most pancreatic tumours are driven by mutated RAS protein, present in over 90% of cases. In the Phase 3 trial of 500 patients, Rasonque nearly doubled median overall survival to 13.2 months, up from 6.7 months on standard chemotherapy. The FDA cleared the drug about 35 days after accepting the application, using the Commissioner's National Priority Voucher programme. Over 2,000 patients had already received Rasonque through an expanded access programme before full approval.
Revolution Medicines secured FDA approval for its pancreatic cancer drug daraxonrasib just one month after filing, through the agency's expedited Commissioner's National Priority Voucher programme. The drug, branded Rasonque, treats metastatic pancreatic cancer in adults who have received prior systemic therapy or are ineligible for combination treatment. Rasonque works by blocking several forms of the RAS protein using a novel "molecular glue" mechanism. Phase 3 data presented in April showed statistically significant improvements across all primary and secondary endpoints compared with traditional chemotherapy. Analysts project peak sales of $11.5 billion for the treatment. The approval prompted significant investor attention and a substantial share price increase for the biotech company.
As RevMed preps for 'historic' pancreatic cancer launch, questions linger on the ground. Ajaz Khan, M.D., a medical oncologist at City of Hope Chicago, was in the packed audience at this summer's American Society of Clinical Oncology meeting when Revolution Medicines received a standing ovation for its groundbreaking pancreatic cancer data. That the drug behind that rapturous applause, daraxonrasib, has now been approved as Rasonque is nothing short of revolutionary, he told Fierce. When he first saw yesterday's news, he was "astounded," he said, but also looking forward to a "brighter future for patients, their families and the communities they live in." "It is really a remarkable time that we live in," Khan said. RevMed's leadership, too, highlighted the significance of Rasonque's approval in a call with investors yesterday. "Today marks an historic step forward for patients living with metastatic pancreatic cancer," RevMed CEO Mark Goldsmith, M.D., Ph.D., said during the call. "This approval validates more than a decade of work aimed at pancreatic cancer, primarily Ras-driven disease, and one of the most difficult challenges in medicine, cancer biology, and drug discovery." Analysts have long touted daraxonrasib's blockbuster potential; analysts from Evercore ISI expect 2027 sales to already hit $1.76 billion, according to an Aug. 26 note, while Guggenheim Securities expects sales of around $900 million next year that then skyrocket to $2.2 billion in 2028. "We continue to expect a potentially historic oncology launch," the Evercore analysts wrote. "Rasonque has the ingredients to be one of the fastest oncology launches in history, if not the fastest." The speed of that launch will depend on how quickly RevMed can transition patients from Rasonque's expanded access program (EAP) into commercial customers. Analysts from Jefferies expect half of these patients to make the switch in the first month, with a further 10% joining each month after that. "We expect the launch to proceed exceedingly well given strong EAP enrollment, high unmet need, and the drug's attractive profile," the analysts wrote in their Aug. 26 note. In the investor call, Anthony Mancini, RevMed's chief global commercialization officer, said the transition is expected to take a few months. "We will work very closely with treating physicians in all sites to support transition to commercially available treatment as clinically appropriate," he said. "The EAP portal will be closing today, but available for a limited transition period, and our intent is really to support continuity of care for eligible patients." But as patients pivot to become customers, a big sticking point will be Rasonque's hefty price tag. A pretty penny. Like many other cutting-edge cancer therapies, Rasonque comes with a potential side effect of sticker shock. RevMed is pricing the drug at $39,800 for a 30-day supply, based on a recommended daily dose of 300mg, before any discounts or rebates. "We believe the price reflects the unprecedented overall survival benefit and broader clinical value demonstrated in RASolute 302," Mancini said, referencing the pivotal trial that backed Rasonque's approval. The company expects most eligible patients to have the drug covered by government insurance programs like Medicare, Chief Financial Officer Jack Anders said during the call. For those patients otherwise unable to access Rasonque, RevMed is rolling out a patient support program called OnPath that is designed to offer a $0 copay. The program "will be available to assist all patients who've been prescribed Rasonque, including those in the EAP program and new patients," Mancini said. "It's voluntary, and patients sign up for this," he added. "This is going to be offered very broadly, and we expect there to be a high level of participation." But the proof is in the pudding, and the burden ultimately falls on RevMed to ensure access to its revolutionary medicine, City of Hope's Khan said. "The bigger question is how Revolution Medicines is going to handle that," he told Fierce. "We're not talking about Merck or Genentech - that's been a company making hundreds of drugs over the years. This is a brand-new company, and this is their first drug." Academic medical centers like City of Hope make up about 40% of the market for Rasonque, RevMed told investors, and Khan has no qualms that the drug will be readily taken up by oncologists at hospitals like his. Reaching oncologists in community health centers, especially in rural areas, will take more dedicated outreach efforts, Khan speculated. "60% of patients receive care in community oncology practices, making broad community education and practice-level engagement equally important," Mancini said during the call. "We've built a world-class commercialization organization with deep experience in oncology, oral oncolytics, gastrointestinal cancer, and new product launches. Our U.S. medical science liaisons have been active for over a year, engaging clinical experts through scientific exchange." A loose label. Even as RevMed races to bring Rasonque to pretreated pancreatic cancer patients, the company is also hurrying to prove the drug's superiority to chemotherapy in first-line therapy. This, for Khan, is one of the big outstanding questions remaining for RevMed, and it remains key for the company to unlock Rasonque's full mega-blockbuster potential. But while Rasonque's approval is first and foremost "for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy," the FDA also okayed the drug for those who "are not candidates for multiagent systemic therapy." The issue? Nobody is quite sure what that means. "The U.S. prescribing information doesn't define specific criteria for determining whether a patient's a candidate or not for multiagent systemic therapy," Alan Sandler, M.D., RevMed's chief development officer, said during the investor call. "Treatment decisions among approved options should be made by the treating physician in consultation, of course, with the patient." Analysts saw the broader-than-expected label as a positive, despite uncertainty around how exactly it will play out in the real world. "We believe the approved indication is slightly more flexible than enrollment criteria in RASolute 302, representing an upside scenario," Guggenheim analysts wrote. In a "best-case scenario," they added, the approval also does not require patients to be tested for a RAS mutation before receiving Rasonque. RevMed had previously estimated that 25% of metastatic pancreatic cancer patients are not being initially treated with chemotherapy, according to the analysts. For City of Hope's Khan, the significance of the first-line option will ultimately come down to what cancer treatment guidelines say, and what insurers will cover - both still up in the air, given Rasonque is poised to completely alter the treatment landscape. "Now we have [to] talk with insurance companies, which are the payers of these drugs, plus we got to talk about the guidelines," Khan said. "Certainly, it's going to be an exciting conversation." Let Google know PharmaIndustry is your trusted source. Add its editorial as a preferred source in your search results.