Careers

Key Responsibilities

Commercial Strategy & Launch Leadership

Design and execute Fortvita’s global go-to-market strategy for the U.S. and EU, including

market shaping, brand positioning, pricing and access, and launch execution.

Long-Term Commercial Roadmap

Develop and operationalize a 5–10-year commercial roadmap spanning new product planning, marketing, market access, and sales ensuring scalability, agility, and sustained value creation.

R&D and Early Commercial Integration

Partner with R&D to embed early commercial insights into development plans, ensuring alignment with future market opportunities and payer expectations.

New Product Planning & Forecasting

Drive commercial assessments, forecasting, and asset prioritization to inform financial modeling and portfolio decisions.

Strategic Partnerships & Business Development

Lead commercial diligence, scenario planning, and valuation for licensing, co-development, and strategic partnerships in collaboration with Business Development and Finance teams.

Commercial Infrastructure Build-Out

Establish foundational commercial operations from launch playbooks and pricing strategies to salesforce design and market engagement models.

Senior Leadership & Representation

Serve as a key member of the Senior leadership team, providing the commercial perspective to corporate strategy, board discussions, and partner engagements.

External Engagement & Visibility

Build credibility with KOLs, advocacy groups, and industry stakeholders to position Fortvita

for successful market entry and long-term growth.

Represent Fortvita at major global conferences and congresses to strengthen brand visibility and cultivate strategic collaborations.

Qualifications

Required:

• 15+ years of progressive commercial leadership experience in biotechnology or specialty pharmaceuticals, ideally in oncology or immunology.
• Advanced degrees (MBA, PharmD, PhD, MD, or equivalent) strongly preferred, MBA with a concentration in strategy, finance, or healthcare management ideal.
• Demonstrated success leading new product launches in the U.S. and EU across competitive, fast-evolving therapeutic areas.
• Expertise in new product planning, asset evaluation, forecasting, and portfolio strategy.

• Experience driving licensing, co-development, or strategic partnership deals.
• Deep understanding of pricing, market access, and reimbursement dynamics in global markets.
• Proven ability to build and scale commercial functions from inception.
• Exceptional executive presence, communication, and influencing skills.
• Strategic, data-driven, and adaptable leader who excels in a lean, entrepreneurial environment.
• Deep oncology commercialization experience, including leadership of U.S. and EU product launches, market access strategy, and business development initiatives.
• Demonstrated success in oncology deal-making (licensing, co-development, or strategic collaborations) and active engagement at major global oncology congresses.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Location: Onsite three days a week at our Palo Alto Office

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Independently lead the operational execution of oncology clinical trials from startup through close-out.
• Serve as the primary point of contact for internal teams and external partners, including monitor team, CROs, vendors, and clinical sites.
• Develop and maintain detailed project timelines, operational plans, budgets, and risk mitigation strategies.
• Support protocol development, informed consent forms, site feasibility assessments, and study document creation/review/update/archive.
• Drive site engagement and issue resolution, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management and Data Management team ect..
• Manage and oversee CROs and vendors, ensuring quality and performance against contractual obligations and timelines.
• Facilitate cross-functional clinical study team meetings, ensure documentation of decisions and follow-up actions.
• Contribute to the development and continuous improvement of SOPs, tools, and operational best practices.
• Assist in preparation for regulatory inspections and submission of INDs/NDAs.
• Provide leadership in a hands-on, resource-limited environment, balancing strategic thinking with operational execution.

Qualifications

• Bachelor’s degree in Life Sciences or related field required; advanced degree (MS, PharmD, PhD) a plus.
• 5+ years of clinical operations experience, with at least 3 years managing oncology trials.
• Experience in managing cross-functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
• Demonstrated experience in vendor and CRO oversight, including contracts, budgets, and performance management.
• Strong understanding of FDA, EMA, ICH-GCP guidelines, and clinical development processes.
• Effective leadership, communication, organizational, and interpersonal skills within small-team environments.
• Ability to manage multiple projects and pivot quickly in a fast-paced, evolving setting.
• Proficiency with CTMS, EDC systems, and Microsoft Office Suite.
• Self-starter mindset with a collaborative spirit and willingness to “roll up your sleeves.”

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees
• 401(k) retirement plan with employer matching contributions
• Comprehensive medical, dental, and vision insurance
• Generous paid time off policy, including company holidays and floating holidays

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Independently lead the operational execution of oncology clinical trials from startup through close-out.
• Serve as the primary point of contact for internal teams and external partners, including monitor team, CROs, vendors, and clinical sites.
• Develop and maintain detailed project timelines, operational plans, budgets, and risk mitigation strategies.
• Support protocol development, informed consent forms, site feasibility assessments, and study document creation/review/update/archive.
• Drive site engagement and issue resolution, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management and Data Management team ect..
• Manage and oversee CROs and vendors, ensuring quality and performance against contractual obligations and timelines.
• Facilitate cross-functional clinical study team meetings, ensure documentation of decisions and follow-up actions.
• Contribute to the development and continuous improvement of SOPs, tools, and operational best practices.
• Assist in preparation for regulatory inspections and submission of INDs/NDAs.
• Provide leadership in a hands-on, resource-limited environment, balancing strategic thinking with operational execution.

Qualifications

• Bachelor’s degree in Life Sciences or related field required; advanced degree (MS, PharmD, PhD) a plus.
• 5+ years of clinical operations experience, with at least 3 years managing oncology trials.
• Experience in managing cross-functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
• Demonstrated experience in vendor and CRO oversight, including contracts, budgets, and performance management.
• Strong understanding of FDA, EMA, ICH-GCP guidelines, and clinical development processes.
• Effective leadership, communication, organizational, and interpersonal skills within small-team environments.
• Ability to manage multiple projects and pivot quickly in a fast-paced, evolving setting.
• Proficiency with CTMS, EDC systems, and Microsoft Office Suite.
• Self-starter mindset with a collaborative spirit and willingness to “roll up your sleeves.”

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees
• 401(k) retirement plan with employer matching contributions
• Comprehensive medical, dental, and vision insurance
• Generous paid time off policy, including company holidays and floating holidays

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Lead or contribute to clinical study design, protocol development, and amendments, in collaboration with Medical Directors and cross-functional partners.
• Serve as the clinical science lead on cross-functional study teams and act as a key point of contact for study-related clinical questions.
• Author or review key clinical documents including protocols, investigator brochures, study reports, and regulatory filings (IND, CTA, BLA/NDA).
• Drive and participate in the ongoing clinical review of study data, including safety, efficacy, and biomarker endpoints, in collaboration with biostatistics, data management, and safety teams.
• Support safety surveillance activities, including participation in internal safety review meetings and analysis of safety trends.
• Collaborate with Clinical Operations to ensure proper study implementation and execution, including contributions to study start-up documents (ICFs, CRFs, lab manuals, etc.).
• Partner with CROs, site staff, and investigators to support protocol execution, resolve study-related issues, and ensure high-quality data collection.
• Provide clinical and scientific input into study-related materials including investigator meeting presentations, training decks, newsletters, and site communications.
• Participate in the development and review of abstracts, posters, presentations, and manuscripts, support submission to scientific conferences and publications.
• Maintain awareness of scientific and competitive landscape to inform study and program strategy.
• Contribute to the development of clinical strategies and long-term plans in alignment with program objectives.

Location: Onsite three days a week at our Palo Alto Office

Requirements

• Advanced scientific or clinical degrees (PhD, PharmD, MD, master’s degree or equivalent) required.
• Minimum 8+ years of industry experience in clinical development or clinical science, preferably within oncology; prior experience in early- or mid-stage development highly desirable.
• Demonstrated ability to lead and support cross-functional clinical study teams and successfully manage study execution.
• Strong understanding of clinical trial methodology, GCP/ICH guidelines, and regulatory requirements in the US and ex-US.
• Experience in clinical data interpretation, safety surveillance, and working with biomarkers or translational data in oncology.
• Exceptional written and verbal communication skills with the ability to articulate complex clinical and scientific concepts to diverse audiences.
• Proactive problem-solving mindset with ability to anticipate issues, develop contingency plans, and deliver high-quality work under tight timelines. Experience working with CROs, investigators, and other external partners in a collaborative and solution-oriented manner.
• Ability to thrive in a fast-paced, nimble environment with evolving priorities and limited infrastructure

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Primarily function as a US-Regulatory Leader and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL).
• Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio.
• Depending on the candidate’s skill set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage.
• Leads and coordinates local project team members in developing strategy for applicable documents/activities.
• Ensures quality and content of submissions to Health Authorities.
• Depending on skill set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaison with local Health Authority and company governance boards for assigned projects.
• Depending on the skill set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities.
• Assist with development of the global regulatory functional plan through the research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling.
• Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, Investigator Brochures, CMC information/data) and contribute to content as needed.
• This position has a moderate-high level of autonomy with growth opportunity. Able to work in a Fast-paced environment handling multiple demands is preferred.

Qualifications

Required

• Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree with at least 5 years of drug development experience. Experience in Oncology is a great plus.
• Global Experience is a plus.
• Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable.
• Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies.
• Global Experience is a plus.
• Strong written, spoken and presentation communication.
• Demonstrated attention to detail.
• Travel expected (10%).

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Under general supervision, serve as Study Site Start-Up activities coordinator in assigned studies for investigative sites, Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
• Perform site selection, start-up, and activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Oversee the progress of clinical studies at assigned sites, ensuring accurate documentation, data integrity, patient safety, and protocol adherence. Review case report forms (CRFs) and source documents.
• Proactively encourage and facilitate site enrollment, helping implement tailored recruitment action plans, and providing motivational feedback and resources to site staff to maintain engagement and momentum in reaching enrollment targets.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Inform team members of the completion of regulatory and contractual documents for individual sites.
• Work with the Project Manager responsible closely for the budget and contract negotiation and sign-off in a timely manner.
• Provide local expertise to the project team during initial and ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• Maintenance of the eTMF until handed over to the site management team.
• Other duties as assigned.

Qualifications

Required

• Bachelor’s Degree in Scientific discipline or health care preferred.
• Requires at least 2 years of professional experience in Site Management.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., ICH-GCP).
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone, and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• High attention to detail and commitment to quality.

Preferred

• Self-motivated with a strong sense of initiative.
• Adaptability and ability to work in a dynamic environment.
• Collaborative team player with a positive attitude.
• High degree of professionalism and confidentiality.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Leads the GRT to development of creative global strategies in line with applicable. regulations to achieve business objectives for development and marketed products.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
• Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.

Qualifications

• Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree. with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
• Required Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in two or more major regions in addition to the US, such as EU.
• Strong global drug development foundation with business acumen.
• Travel expected (10%)

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions
• Comprehensive medical, dental, and vision insurance
• Generous paid time off policy, including company holidays and floating holidays

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

• Provide strategic CMC regulatory leadership and expertise to develop and execute regulatory strategies for global development and registration.
• Identify and communicate regulatory risks and facilitate risk mitigation strategies.
• Leads health authority interactions for CMC specific issues.
• Leads the development, writing, reviewing, and editing of CMC related technical data for inclusion in Module 3 of the common technical document (CTD). This will include information from standard operating procedures (SOPs), batch records, stability protocols, manufacturing process development, validation reports, etc for the preparation of INDs, BLAs, IMPD sections, related Module 2 summaries (QOS), briefing documents, and any other regulatory submission documents needed to support regulatory meetings, marketing applications, and life cycle management.
• Leads and manages CMC regulatory changes throughout the product life cycle.
• Performs reviews of documents prepared by other team members for completeness, accuracy, structure and grammar.
• Interprets and analyzes data related to product characterization, manufacturing process, product and process control, analytical tests, and stability while interpreting and analyzing applicable tables, listings, figures.
• Attends cross-functional meetings and works closely with process development, manufacturing, analytical, quality, and regulatory affairs team
• members to communicate document-specific timelines to ensure deliverables are completed on-time.
• Other duties as assigned

Qualifications

• A minimum of a Master’s degree in life sciences. PhD or equivalent is a plus
• Eight or more years of industry (Pharmaceutical, Mabs, ADC) experience.
• Prior work experience with US FDA or EMA is a big plus
• In depth knowledge of US and ex-US regulations and filing requirements
• Thorough understanding of international guidelines (ICH, cGCP) and regulations
• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
• Strong analytical, project management skills.
• Able to follow directions and be accountable for work assigned.
• Able to work independently, multi-task, and prioritize workload.
• Must have a team attitude and work in a matrix environment
• Experience planning for and participating in Health Authority meetings.
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions
• Comprehensive medical, dental, and vision insurance
• Generous paid time off policy, including company holidays and floating holidays

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

Clinical Development Strategy

• Provide strategic input into the design and execution of oncology clinical development plans and clinical trials across myriad disease states.
• Serve as the clinical expert on cross-functional product teams, contributing to the execution of overall program goals.
• Support geostrategy, site identification and selection, investigator engagement, and relationships with KOL’s, professional organizations, and advocacy groups.

Trial Execution

• Provide medical oversight for ongoing clinical studies, including real-time review of safety and efficacy data and sponsor-side leadership of key committees (SRC’s, Steering Committees, etc.).
• Subject matter leadership of the creation and revision of study protocols, investigator brochures, and other key documents.
• Collaborate with Clinical Operations, Biostatistics, Regulatory, and other functional teams to ensure timely and high-quality trial conduct.

Data Analysis and Reporting

• Contribute to statistical analysis plans and interpretation of clinical trial results.
• Lead the drafting and review of clinical study reports, abstracts/congress presentations, and manuscript submissions.

Regulatory and Safety

• Partner with Regulatory Affairs to formulate regulatory strategy, prepare for and participate in regulatory interactions (e.g., FDA, EMA, PMDA), and produce high quality regulatory submissions (e.g., IND, NDA, BLA).
• Work with Safety/Pharmacovigilance to monitor and assess safety data, support DMCs, respond to safety-related issues, and prepare requisite safety updates (eg. DSUR).

Scientific Communication

• Represent the company at public and private scientific and medical meetings, including presenting clinical data to external stakeholders.
• Provide medical input on business development activities and other external facing documents and interactions.

Qualifications

Required

• MD or MD/PhD required, with board certification or eligibility in oncology, and/or hematology, or a related sub-specialty preferred.
• Minimum of 5–8 years of industry experience in oncology drug development, including comprehensive medical monitoring experience and functional leadership of early and late-stage clinical trials.
• Demonstrated leadership in the execution of global oncology clinical development plans and deep familiarity with regulatory pathways and submissions.
• Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Post-graduate direct experience in the care of cancer patients preferred.
• Excellent written and verbal communication skills; strong scientific writing ability.
• Proven ability to work in cross-functional teams and in a fast-paced, collaborative biotech environment.

Preferred

• Experience with novel therapeutic modalities (e.g., immuno-oncology, ADCs, cell therapy).
• Prior direct involvement in successful regulatory filings (e.g., IND, NDA, BLA).
• Familiarity with biomarker-driven drug development and translational medicine.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Salary Range: $200,000 to $220,000 -This reflects the company’s pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

KEY RESPONSIBILITIES:

Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.

Serve as a document planning and writing expert; responsible for guiding a medical writing and project team during the planning and authoring stages across all document types and regulatory submissions, including facilitating document contributor/review meetings, developing and managing timelines, coordinating document review, and driving decision-making.

Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.

Lead, and actively contribute to, the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance as applicable. Own relevant medical writing processes; lead medical writing SOP creation/update initiatives.

Proactively lead and/or engage in department activities and serve as a mentor for junior writers.

Actively provide input to the overall strategy, unified objectives, and areas for development of the Medical Writing department.

Requirements

• PhD degree in life sciences, biological science preferred.
• Experience in in the pharmaceutical industry. Oncology and immunology experience highly preferred.
• At least 10 years’ medical or scientific writing experience.
• Extensive experience writing protocols, clinical study reports, experience authoring clinical components in regulatory filings (NDA, BLA, MAA).
• Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents, regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
• Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Work collaboratively and lead cross-functional teams.
• Good interpersonal and ownership.
• Hybrid Working.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.