Senior Director, Preclinical Development

About Fortitude Biomedicines:

Fortitude Biomedicines is a cutting-edge biotechnology company dedicated to advancing immunotherapy and biologics research. One of our missions is to accelerate the development of novel cancer treatments by leveraging Fortitude Bio’s Glue-DAC platform, an ADC drug discovery engine using a proprietary protein degrader payload. In our fast-paced environment, we value entrepreneurial spirit, adaptability, and a commitment to transforming patient care.

Responsibilities:

  • Strategic Leadership: Oversee the design, execution, and interpretation of preclinical studies, including DMPK, toxicology, and pharmacology assessments, to support biologics and ADC development in autoimmune and oncology indications.
  • CMC Oversight: Direct CMC activities, including process development, manufacturing scale-up, formulation, and analytical methods for biologics and ADCs, ensuring alignment with regulatory requirements and timelines.
  • IND Preparation and Filing: Lead the preparation and submission of IND applications for biologics and ADCs, collaborating with regulatory affairs, quality assurance, and clinical teams to compile comprehensive data packages.
  • Team Management: Build and mentor a high-performing preclinical team, fostering innovation and collaboration across functions such as research, clinical development, and operations.
  • Risk Assessment and Mitigation: Conduct thorough toxicity evaluations and DMPK profiling to identify potential risks early, informing go/no-go decisions and optimizing candidate selection.
  • Cross-Functional Collaboration: Partner with internal stakeholders and external CROs, CMOs, and academic collaborators to advance programs efficiently while managing budgets and timelines.
  • Regulatory Compliance: Ensure all preclinical activities adhere to GLP, GMP, and relevant FDA/EMA guidelines, staying abreast of evolving regulations in biologics and ADCs.
  • Scientific Innovation: Contribute to pipeline strategy by evaluating new technologies and approaches in developability DMPK, toxicology, and CMC to enhance our autoimmune and cancer therapeutics.

Qualifications:

  • Advanced degree (PhD, MD, or equivalent) in Pharmacology, Toxicology, Pharmaceutical Sciences, or a related field.
  • Minimum of 8-10 years of progressive experience in preclinical development within the biotech or pharmaceutical industry, with a focus on biologics and ADCs.
  • Demonstrated leadership in DMPK and toxicology, including hands-on experience with study design, data analysis, and integration into development plans.
  • Proven track record of leading successful IND filings for biologics and ADCs; experience with multiple IND submissions is required.
  • Strong understanding of CMC principles for large molecules, including conjugation chemistry for ADCs.
  • Excellent communication and presentation skills, with the ability to influence at all levels and represent the company externally.
  • Experience managing cross-functional teams and external partnerships in a fast-paced environment.

Preferred Qualifications:

  • Prior experience in autoimmune disease or oncology therapeutic areas.
  • Familiarity with advanced modalities such as bispecific antibodies or novel linker-payload technologies in ADCs.
  • Board certification in toxicology (e.g., DABT) or equivalent credentials.
  • Track record of publications in peer-reviewed journals and presentations at scientific conferences.

Our Culture:

We value quality, accountability and empowerment. We take pride in producing the highest quality results. Quality is never compromised. We honor our commitments every day and strive to exceed our expectations. How we accomplish our goals is as important as the results themselves. We work collaboratively to empower each other, knowing that strong teams create exceptional results.

What We Offer:

  • The opportunity to shape the future of oncology therapeutics in a groundbreaking startup biotech.
  • Competitive salary, equity package, and benefits tailored to early-stage innovation.
  • A collaborative, inclusive culture where your ideas have impact.

Location:

Waltham, MA (hybrid)

 

Qualifying candidates: If you are a passionate leader ready to tackle cancer’s toughest challenges in a nimble startup, we encourage you to apply. Please submit your resume to careers@fortitudebio.com.

Thank you for your interest in Fortitude Biomedicines!

 

Fortitude Biomedicines is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Fortitude Biomedicines does not accept unsolicited resumes from search firms for listed employment opportunities. All unsolicited resumes submitted through our website shall be deemed property of Fortitude. Fortitude explicitly reserves the right to pursue and hire those candidates without any financial obligation to the recruiter or search firm.

Yan Wan

Vice President, China Site Head

Ms. Wan brings extensive expertise in corporate operations, with a versatile background spanning human resources, procurement, legal, IT, finance, government affairs, and R&D alliance management. Prior to joining Fortitude Biomedicines, she served as General Manager, China at Terns Pharmaceuticals, where she played a pivotal role in the company’s launch, operational build-out, and successful NASDAQ IPO.

Earlier in her career, Ms. Wan provided HR leadership supporting both the commercial franchise and global drug development units at Novartis China. She began her operations career in Germany at an overseas R&D center. Ms. Wan holds dual bachelor’s degrees in Literature and Economics from Wuhan University of Technology, as well as a postgraduate degree from the University of Hong Kong Business School.

Kathy Derakhchan, Ph.D.

Executive Director, Preclinical Development

Dr. Derakhchan leads preclinical development efforts at Fortitude Biomedicines. She has proven track record of leading multiple successful IND/NDA filings with corresponding track record of publications in peer-reviewed journals and presentations at scientific conferences. Dr. Derakhchan has extensive experience in engaging with regulatory authorities and in developing, designing, and overseeing non-GLP, GLP, and IND-enabling pharmacology, PK/PD efficacy, safety pharmacology, investigative toxicology and general toxicology evaluations of therapeutics from early-stage discovery to FIH and post approval. Prior to joining Fortitude, she held positions of increasing responsibility at Amgen, Shire and Takeda. Dr. Derakhchan received her PhD in Pharmacology from Université de Montréal.​

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Rahul Patel, M.D., FACR

Senior Vice President, Clinical Development

Dr. Patel leads Fortitude Biomedicine’s Clinical Development efforts of the company’s therapeutic programs. He is a board-certified rheumatologist with more than 15 years of experience in clinical drug development within the biopharmaceutical industry. His work has contributed to the successful regulatory submission and approval of two immunotherapies. Prior to joining Fortitude, Dr. Patel founded AyurBioConsulting, where he provided strategic and operational support on programs focused on autoimmune disease indications. Previously, he served as Executive Medical Director at ImmPACT-Bio and KyvernaTherapeutics. Over the course of his career, he held positions of increasing responsibility at BioCryst, PRA Health Sciences, Sanofi and PAREXEL. Dr. Patel earned his Doctor of Medicine from Baylor College of Medicine and completed his fellowship in Rheumatology at University of Texas Southwestern Medical Center.

Keith Dewedoff

Acting CFO

Keith brings more than 20 years of experience in the life sciences industry to Fortitude Biomedicines, ranging from venture-backed biotech startups to commercial publicly traded companies. Prior to joining Fortitude, he served as CFO at Carbon Biosciences, Code Biotherapeutics, and Ceptur Therapeutics; additionally, he was an advisor to various venture funds. Keith is also CFO & advisor to Spy Biotech,  co-founder and exec chairman of Kaizen Biosciences and advisor at Danforth Health. Keith holds a Bachelor of Science in Economics & Management from Northeastern University.

Stephen Monks, Ph.D.

Acting Chief Development Officer

Dr. Stephen Monks leads Fortitude Biomedicine’s Development efforts. He is a seasoned biopharmaceutical development executive with more than 25 years of experience guiding CMC strategy, technical development, and regulatory execution from early research through late-stage clinical development. Before consulting, Dr. Monks served as Chief Technology Officer at Pyxis Oncology, where he led the technical build-out of the company’s ADC and immuno-oncology antibody platforms and also oversaw the company’s CMC strategy, CDMO selection and management, and regulatory planning efforts to support pipeline advancement. Dr. Monks received his PhD in Biochemistry from University of Melbourne, Australia.

Wendi Ni

Director, Head of Corporate Development

Wendi leads the Operations and Corporate Development efforts of Fortitude Biomedicines. She has more than ten years of research experience and is passionate about building biotech startups. Prior to joining Fortitude, she was Senior Scientist at Novartis, driving drug discovery efforts across various modalities, including antibody-drug conjugates, bispecifics, and radioligand therapy. Wendi received her Master of Science in Pharmacology and Drug Development from Tufts University School of Medicine.

Matthew Huggins, Ph.D.

Principal Scientist, Immunology

Dr. Huggins is an immunologist with expertise in preclinical drug development across autoimmune diseases and oncology. At Fortitude, he serves as project lead for the company’s lead program, driving the research strategy for advancing this development candidate into the clinic. Prior to joining Fortitude, Matthew led multiple early-stage discovery programs from proof of concept through IND-enabling studies. Dr. Huggins received his Ph.D. in Immunology from the Mayo Clinic in 2017.

Haibo Liu, Ph.D.

Director, Medicinal Chemistry

Dr. Liu leads the GLUE-DACTM platform and ADC Discovery efforts at Fortitude Biomedicines. He is an accomplished medical chemist bringing over 15 years of drug discovery experience. Prior to joining Fortitude, he was the Director of Chemistry at Matchpoint Therapeutics. He held positions of increasing responsibility at Avila, Celgene, BMS, and Matchpoint. Dr. Liu received his Ph.D. in Chemistry from Stanford University.

Jan Theunissen, Ph.D.

Vice President, Discovery

Dr. Jan Theunissen leads Discovery efforts at Fortitude Biomedicines and brings over 15 years of industry experience in antibody drug development across diverse target classes and disease indications. He is an accomplished biotechnology leader with deep expertise in the preclinical discovery and development of novel antibodies and antibody-drug conjugates. Prior to joining Fortitude, he served as Director of Biology at Mersana Therapeutics and Senior Director of Research at Iconic Therapeutics. Earlier in his career, Dr. Theunissen held positions of increasing responsibility at Amgen, Igenica Biotherapeutics, and Gilead Sciences. Dr. Theunissen received his PhD in Molecular Biology from Cornell University.

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Jesse Chen, Ph.D.

President and CEO

Jesse is the Founder, President and CEO of Fortitude Biomedicines. A serial entrepreneur, he previously co-founded both TRIANA Biomedicines and Avilar Therapeutics. Before launching Fortitude, he served as Chief Technology Officer at TRIANA Biomedicines. Jesse brings nearly two decades of discovery research and management experience, spanning early discovery through preclinical development. He previously served as an entrepreneur-in-residence for RA Capital Management. Prior to joining RA Capital, he was Senior Director of Discovery at Kymera Therapeutics, responsible for building the company’s industry-leading targeted protein degradation platform and pipeline. Jesse held roles of increasing responsibility at Moderna Therapeutics and Millennium Pharmaceuticals, leading efforts to developing novel platforms and discovery programs.