Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon's proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. These distinctive capabilities enable AP3's direct application for drug design optimization for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon's drug candidates.
Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. Acrivon's ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered preclinical stage pipeline programs. These include ACR-2316, a potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors, and a cell cycle program with an undisclosed target.
Our global team operates out of two leading life science clusters, Watertown, MA and Medicon Village in Lund, Sweden.
We are seeking a Medical Director, Clinical Development who will be responsible for ensuring the eligibility, safety, and data integrity of our clinical studies. As such, the Medical Director will be a key face and the voice of Acrivon for the 60+ sites where the ACR-368 study is currently ongoing.
Their primary role will be to be partner with sites (PIs, sub-PIs, study coordinators) to ensure the best possible execution of our studies while also showcasing the values of Acrivon and how they translate to Clinical Research.
Depending on the candidate's level of experience and skills, this position also offers the opportunity to contribute to the design of Acrivon's forward-looking clinical strategies, including the planning and implementation of new clinical programs. The position reports to the Chief Medical Officer.
Duties and Responsibilities:
- Execute operational clinical development plans in conjunction with a cross-functional clinical operational development sub-team to ensure impeccable patient management and data integrity.
- Provide clinical input to research and translational medicine teams in the development of clinical biomarker plans and assure accurate integration of translational medicine objectives into the clinical development plan and protocols, lab manuals, informed consent, and samples, when requested by the Biomarker team.
- Be part of a cross functional team to execute according to the Clinical Development Plan, GCP requirements, and internal compliance processes, for ensuring the integrity of study conduct and patient safety, including oversight of the Risk management plan, Medical monitoring plan, Safety management plan, consultation with subject matter experts as needed, direct conversations with PI's and site staff, tracking and analysis of queries and protocol deviations, and active interaction with study vendors and personnel.
- Lead the medical oversight of ongoing or new company sponsored and investigator initiated clinical trials working with cross-functional teams, external vendors, and advisors including weekly PI calls, Steering Committee meetings, advisory boards, study milestone tracking, and on-going study analysis.
- Collaborate with external medical monitors and safety teams to safeguard patient safety in studies through excellence in design and ongoing safety/medical monitoring during study conduct and follow-up, including but not limited to review of medically important events (AEs, SAE's, AEs leading to discontinuation, DLTs, subject withdrawal, appropriate consenting, patient eligibility assessment, protocol deviations).
- Participate in the analysis of clinical findings from studies to support decisions regarding safety and efficacy. Supports authorship of clinical study reports, publications, presentations, regulatory communications, PI and site training, study amendments, IRB and ICF updates, IB updates, and new drug applications.
- Be a primary external face of the program(s) to key opinion leaders, clinicians, and others in the medical community. Ensure appropriate medical advisory expert input into all aspects of program strategy and execution. Support sites and investigators in all matters relevant to study processes.
- Communicate clearly across the organization, ensuring alignment cross-functionally, with leadership, and with external advisors.
- Establish relationships with key external clinical experts and institutions to ensure implementation of latest clinical thinking and guidelines into clinical development plans, and to establish collaborations for research innovation.
- Provide medical support for regulatory documents creation (e.g., briefing books, INDs, NDAs etc.).
Requirements and Qualifications:
- MD or MD/Ph.D., with board eligibility/certification in Oncology.
- Candidates with experience in industry (one to three years' industry experience in oncology clinical research and development) are encouraged to apply and will have a comprehensive understanding of the drug development process and a proven track record of success in participating in the development of and executing development programs.
- Candidates who have completed their oncology or internal medicine training are also encouraged to apply. This position constitutes a great opportunity to move from academia to biotech by using their medical training to be immediately step into an operating role, while learning the nuts and bolts of biotech-driven drug development.
- Candidates should have documented contribution of the execution of oncology clinical trials as a PIs or sub-I or as part of the clinical team running oncology trials at their institution.
- Prior clinical experience in phase 1-2 studies in oncology as clinical investigator or monitor / clinical director.
- Strong scientific background, able to provide detailed guidance to clinical investigators.
- Experience with translational biomarkers, clinical biostatistics, clinical data management, clinical biomarker strategy and implementation.
- Understanding of the importance of the ICH regulation, capable of operating in a highly regulated industry.
- Demonstration of effective teamwork as well as analytical and problem-solving abilities.
- Outstanding communication (verbal, written, listening) and interpersonal skills with the ability to communicate effectively across different levels of the organization. The candidate will be able to interact daily with people from a broad range of seniority and be able to build professional, courteous relationship at different levels of each organization Acrivon is working with.
- Curiosity and intellectual nimbleness to adjust to a fast-paced biotech environment by incorporating uncertainties and ambiguity to the decision-making process.
- Successful track record in planning and conducting clinical trials.
- Good project management skills: ability to track and influence multiple activities lead by various functional sub-teams to ensure deliverable of key milestones.
- Must be highly proficient, Microsoft Office Suite, the candidate must be able to execute analysis of available data and to craft convincing messages for various audiences.
- Domestic and international travel up to 25% may be required.
Acrivon Therapeutics is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, Acrivon Therapeutics complies with applicable state and local laws governing nondiscrimination in employment.