Director/Senior Director, Medical Affairs
5 days ago
San Diego
Job Description About BlossomHill Therapeutics: BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. For more information visit BlossomHill Therapeutics. Position Summary: The Director/Senior Director, Medical Affairs – Oncology is a senior leader responsible for driving the medical strategy and external engagement for the company's oncology portfolio. This individual contributor serves as a key scientific partner to Clinical Development, Regulatory Affairs, Commercial, and Executive Leadership, and is the primary medical authority for external stakeholder interactions. This individual will deliver evidence-based, patient-centric medical strategies that support peri-launch and lifecycle commercialization of oncology assets. The role requires a physician-scientist, PharmD or PhD-level clinical scientist with deep therapeutic area expertise, a track record of meaningful contributions to peer-reviewed literature and demonstrated ability to lead in a fast-paced, early and late-stage drug development environment. The ideal candidate brings operational fluency across early-phase oncology trials, medical congress strategy, publication planning, KOL and advisory board engagement. This is an onsite position based in San Diego. Key Responsibilities: Medical & Scientific Leadership • Define and own the therapeutic area medical strategy, integrating scientific intelligence and clinical evidence to inform product and publication strategy, and evidence generation priorities., • Drive medical content in collaboration with Research and Clinical Development for portfolio, ensuring alignment between global and local medical plans and regulatory milestones., • Drive scientific data packages for product positioning, regulatory filings, and evidence generation, from sponsored trials and pre-clinical studies., • Guide the identification, cultivation, and engagement of KOLs, advisory boards, cooperative groups, and professional societies for external advocacy and scientific exchange. Manage advisors contributing to company visibility at congresses and in professional societies., • Review and provide medical/scientific oversight for external grants, donations, and sponsorship requests consistent with company policies and compliance standards. Cross-Functional Leadership & Internal Partnership • Serve as a core member of the Medical Affairs leadership team, • Collaborate with Clinical Development and Patient Advocacy to generate compliant medical education and disease awareness initiatives., • Provide medical guidance to Legal and key functions on scientific claims, labeling, promotional review., • Collaborate with key functions to drive and optimize investigator engagement and patient enrollment., • Develop and maintain KOLs relations relevant to the study pipeline to facilitate site identification, referral networks, and investigator-initiated trial discussions. Medical Congress Strategy & Scientific Communications • Lead and coordinate the company's scientific presence at key oncology conferences, including abstract submissions, oral presentations, poster presentations, and symposia., • Author and review externally facing material, scientific abstracts, slide decks, and poster content; ensure accuracy, consistency with data packages per publication and medical plan, • Serve as an authoritative company spokesperson in external medical settings., • Monitor the evolving competitive landscape, published literature, and regulatory guidance to ensure trial designs reflect current clinical standards and regulatory expectations., • Plan, organize, and lead advisory board meetings (global and regional), including scientific agenda development, faculty selection, briefing document preparation, and post-meeting follow-up. Publication Planning & Medical Writing Leadership • Develop and execute a comprehensive, integrated publication plan aligned with the clinical development plan and regulatory milestones., • Oversee the preparation and submission of manuscripts, review articles, case reports, and supplementary data packages for peer-reviewed journals., • Manage authorship, policy compliance per ICMJE guidelines, and medical writing vendors., • Partner with key functions to ensure accuracy and interpretability of data presented in publications. Operational Excellence, Culture & Compliance • Support and contribute to a high-performing, inclusive team culture that rewards innovation, intellectual curiosity, scientific rigor, and collaboration., • Establish and track effectiveness of KPIs, with continuous improvement mindset, • Ensure all Medical Affairs activities are conducted in strict accordance with applicable laws, regulations, company SOPs, and ethical standards, • Maintain training compliance and clear accountability for regulatory and policy adherence., • Reinforce inclusive leadership through modeled behaviors promoting psychological safety, equitable participation, and authentic professional expression for all team members. Qualifications: Required • MD, PharmD and/or PhD (or equivalent doctoral degree) in a relevant biomedical discipline; board certification or sub-specialty training in oncology/hematology highly preferred for MD candidates., • Minimum of 10 years of progressive experience in oncology drug development, medical affairs, or clinical research with at least 7 years in Medical Affairs., • Demonstrated expertise in the targeted therapies (e.g., small molecule inhibitors, ADCs, bispecifics)., • Proven track record in the design and execution of clinical trials; experience contributing to registrational and non-registrational study designs., • Strong publication record; demonstrated leadership of publication plans and manuscript preparation., • Experience organizing and facilitating ad boards and scientific steering committees with global KOLs., • Experience presenting or coordinating scientific content at major oncology congresses, • Thorough understanding of ICH/GCP guidelines, FDA/EMA regulatory framework, and applicable medical affairs compliance standards (PhRMA Code, ICMJE, GPP). Preferred • Industry experience in biotech or pharma at Dir. level in Medical Affairs or Clinical Development., • Experience with early-stage drug and companion diagnostic co-development. Salary Range: The base salary range for this position is $249,292 to $310,553 When determining the final offer, we consider multiple factors including, but not limited to, relevant education, skills, and years of experience, internal pay equity, geographic location, and market data. Equal Employment Opportunity: The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHill employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired. E-Verify: BlossomHill Therapeutics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) to resolve the issue.