Source Job

• Own integrated program strategy for TIL cell therapy assets across early-to-late-stage clinical development.
• Chair cross-functional program teams, manage timelines, and translate strategy into execution.
• Partner with senior leadership to advance programs from early studies to global regulatory submissions.

Iovance Biotherapeutics is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. The company operates as an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing and is committed to a diverse and inclusive work environment.

• Serve as a TIL cell therapy expert in Medical Affairs, educating providers and optimizing tumor tissue procurement.
• Lead engagement with surgeons and cross-functional teams to support clinical trials and medical strategy.
• Represent Iovance at professional meetings and contribute to publications and educational materials.

Iovance Biotherapeutics is a global leader in developing tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. It is an end-to-end cell therapy company with U.S.-based manufacturing and an inclusive culture.

• Advance the medical strategy within the assigned territory through fair-balanced, evidence-based scientific exchange and credible partnership with the healthcare community.
• Deliver high-quality scientific and clinical presentations on disease states and Iovance products to internal and external audiences, tailoring content to audience needs.
• Build and sustain relationships with external experts, collect field medical insights, and support clinical trial site identification and execution.

Iovance Biotherapeutics is a global leader in developing tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. It is an end-to-end cell therapy company with centralized U.S.-based manufacturing, serving thousands of cancer patients worldwide each year.

• Set and communicate the global commercial strategy and own P&L for the Proleukin business across U.S. and international markets.
• Partner with Clinical, Regulatory, Medical Affairs, Sales, Market Access, and Manufacturing to align commercial plans, supply, and compliance.
• Lead staffing, talent development, and succession planning while overseeing distribution, revenue forecasts, and risk management.

Iovance Biotherapeutics is the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with the first FDA-approved one-time treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization, anchored by centralized U.S.-based manufacturing, and fosters a culture of innovation, integrity, and inclusion.

• Lead and manage the assigned clinical operations team, setting and executing departmental strategy.
• Oversee clinical trial agreements, budgets, and the timely execution of clinical research programs from conception through final study report.
• Maintain oversight of study conduct at sites, ensure adherence to protocols and GCP, and serve as company representative at external meetings.

Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. As an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing, it operates with a fast-paced, collaborative culture focused on bringing first-in-class treatments to cancer patients.

• Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
• Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
• Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.

Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.

• Build and lead field operations infrastructure for Definium's first commercial launch, including territory management, CRM workflows, and incentive compensation.
• Partner with Commercial Analytics, Field Strategy, IT, and cross-functional teams to translate commercial strategy into reliable field processes.
• Scale operations from pre-launch through commercialization while ensuring data integrity, compliance, and vendor oversight.

Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop treatments for psychiatric and neurological disorders. Headquartered in New York and trading on Nasdaq, the company is advancing a lean, collaborative culture focused on turning evidence into impact.

• Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
• Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
• Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.

A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.

• Build and maintain territory-level performance dashboards and scorecards for the US field organization.
• Develop sub-national analyses including geographic demand modeling, ATC penetration analytics, and field force effectiveness.
• Partner with commercial data systems to ensure data quality and deliver actionable insights to field leadership.

Iovance Biotherapeutics develops tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, including the FDA-approved Amtagvi for advanced melanoma. They are an end-to-end cell therapy company with centralized U.S. manufacturing and a growing commercial network.

• Lead commercial operations and analytics for the U.S. launch of deramiocel, a cell therapy for Duchenne muscular dystrophy.
• Build and oversee commercial data ecosystem, analytics, forecasting, and field operations.
• Establish scalable processes, governance, and cross-functional partnerships to drive launch readiness.

Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The company is publicly traded and fosters a collaborative, mission-driven culture focused on innovation and patient impact.

• Develop and execute U.S. stakeholder engagement strategies for advocacy and professional societies.
• Build relationships with KOLs, patient advocacy groups, and oncology experts.
• Lead regional oncology conferences and advocacy events for launch readiness.

Iovance Biotherapeutics is the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving cancer patients worldwide.

• Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
• Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
• Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.

Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.

• Drive global PV Operations strategy, including planning, implementation, and management, in alignment with the Head of DSPV.
• Oversee vendor oversight, case management, compliance, inspection readiness, and budget/resourcing.
• Represent DSPV Operations to senior leadership, manage talent, and ensure global regulatory compliance.

Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, we foster a culture of empathy, owner's mindset, and urgency because patients are counting on us.

• Own commercial growth for biotech and small-to-mid-sized pharma, including revenue, strategy, and pipeline.
• Personally close first deals with founders and executives while building and leading a high-performing sales team.
• Define go-to-market strategy, prioritize high-value use cases, and partner with Customer Success for expansion.

Hippocratic AI builds the leading frontier model for healthcare, powering safe, autonomous clinical conversations with patients and HCPs. It is one of the fastest-growing health-tech companies, backed by top investors with $404M in funding and a team of experts from leading institutions.

• Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
• Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
• Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.

Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.

• Contribute to regulatory strategies and coordinate interactions with health authorities.
• Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
• Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.

• Own the Field Excellence operating model nationally, including cadence, standards, tools, and escalation protocols.
• Serve as the single operational partner to the VP Sales, managing territory, IC questions, and business review preparation.
• Manage and develop two Directors of Field Excellence and ensure launch readiness across all geographies.

Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies. The company is building its commercial infrastructure for a first US launch, with a mission-driven culture emphasizing integrity, collaboration, and commitment to people.

• Partner with top global pharma organisations to implement Veeva Commercial Cloud products
• Lead business process discovery, solution design, and project delivery
• Manage stakeholders and serve as solution architect, project manager, and business analyst

Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue and foster a culture of autonomy, customer success, and employee success.

• Design and launch a virtual engagement model to cover open territories and extend reach to priority HCPs.
• Lead the virtual engagement team, coordinating with field sales, marketing, and compliance for consistent omnichannel experiences.
• Manage vendors, budgets, and performance metrics to refine coverage and drive business results.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines targeting hypertension and related comorbidities such as chronic kidney disease and obstructive sleep apnea. The company is fully remote, preparing for its first commercial launch with a fast-paced, high-growth culture.

• Provide strategic leadership and operational oversight for clinical trial design, analysis, and reporting.
• Build and mentor a high-performing clinical biostatistics team while driving regulatory submissions.
• Partner with cross-functional teams and vendors to ensure high-quality statistical and data management support.

Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than industry standard. With over $845M in total funding and a $2B valuation, the company is recognized as a top startup employer and has three oral medicines in the clinic.