PHARMABCINE, POSITION DESCRIPTION CHIEF MEDICAL OFFICER

PharmAbcine Inc.; Brisbane; On-site; AUD 360,000 - 600,000; Full time

Job summary

PharmAbcine, Inc. in Brisbane, Australia seeks a Chief Medical Officer to lead the clinical development strategy across oncology and related diseases.

You will oversee trial design, regulatory interactions, and IND/MAA submissions, and guide medical affairs and biometrics in partnership with the CEO and executive team. The CMO will manage clinical operations and patient advocacy, mentor senior staff, and represent the company to investors and partners.

Qualifications

• The ideal candidate will offer an MD with Oncology Board certification and extensive pharma/biotech sponsor experience.
• Proven leadership of clinical groups including medical affairs and operations.
• Strong track record in Phase I–IV trials and regulatory filings (INDs, BLAs, MAAs).

Responsibilities

• Direct development of clinical strategies and plans for oncology and eye diseases.
• Oversee regulatory strategies and interactions with Health Authorities.
• Analyze and interpret clinical trial data and report results.
• Lead interactions with academic leaders, investigators and groups.
• Represent the company to investors, regulators and partners.
• Oversee Clinical Research, Clinical Operations, Medical Affairs and Biometrics teams.

Skills

Fluent English

Leadership

Strategic thinking

Regulatory knowledge

Education

MD with Board Certification in Medical Oncology

Medical degree with Oncology training

Tools

IND/MAA submissions

Job description

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CHIEF MEDICAL OFFICER POSITION DESCRIPTION

Job Title: Chief Medical Officer

Reports to: Chief Executive Officer

Company Summary:

PharmAbcine, Inc. is a DAEJEON, SOUTH KOREA based Clinical stage KOSDAQ listed public company committed to developing next generation antibody therapeutics for the treatment of various cancers and other unmet need diseases. It has subsidiary in South San Francisco, USA and in Brisbane, Australia. Its Seoul office is located in IFC tower for Clinical Research Team.

The company’s HuPhage display fully human antibody library and innovative antigen customized selection system delivered Olinvacimab, anti-human VEGFR2 neutralizing fully human IgG with unique epitope. Its phase I and II delivered clear safety profile and efficacy.

PharmAbcine’s current clinical program for its lead product candidate Olinvacimab includes three clinical trials, a Phase 2 studying Olinvacimab as cerebral edema reliever for the treatment of Avastin non responding recurrent GBM patients with severe cerebral edema in US and Australia, and two Phase 1b Keytruda combo trials in patients with recurrent GBM or metastatic Triple Negative Breast Cancer under the clinical collaboration with MSD. Currently, several combo/mono Olinvacimab trials are in preparation. The company is building a pipeline of additional product candidates targeting VISTA (V-domain Immunoglobulin Suppressor of T cell Activation) as next generation immune oncology drug, PMC-309, targeting TIE2 antibodies, PMC-402 and PMC-403 which play pivotal role in normalization of pathological disorganized leaky vessels. PMC-309, PMC-402 and PMC-403 are in the development stage for their Phase I IND filing 2021 and 2022.

Position Summary:

The Chief Medical Officer will report directly to the Chief Executive Officer. The primary role of the CMO will be to provide leadership and direction for PharmAbcine’s pipeline of clinical development programs in both cancer and other diseases including AMD, DR, and Glaucoma. The CMO will be responsible for the strategy, direction and execution of the company’s clinical development plans.

The CMO will be a key member of the senior management team as a member of the company’s Executive Committee which determines and oversees research and drug development at PharmAbcine and sets the overall strategic direction of the company. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth stage biotechnology company.

Essential Duties and Responsibilities:

• Direct the development of clinical strategies and plans to integrate PharmAbcine Inc. compounds into the standard practice of oncology, vessels and eyes diseases.
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities.
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
• Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
• Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy.
• Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators and partners.
• In addition to leading and supervising the Clinical Research Department, the CMO will have direct line responsibility for the Clinical Operations, Patient Advocacy, Medical Affairs, Clinical CROs, Clinical Consultant, and Biometrics Departments.

Qualifications:

Education/Experience: The ideal candidate will offer:

• MD with Board Certification in Medical oncology or Family/Pediatrics with Oncology training preferred.
• 10+ years minimum experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
• Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations.
• A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s).

Knowledge, Skills and Abilities:

• Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus.
• Experience with, or strong knowledge of Oncology drug development, especially biologics or antibody based.
• Experience or knowledge of Orphan or rare disease drug development a plus.
• Experience in translational medicine, clinical pharmacology and early stage development is desirable.
• Excellent knowledge of the competitive environment for drugs in the Hematology/Oncology marketplace and in research and development pipelines.
• Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
• The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community.
• Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
• Must be science- and data-driven.
• For best fit, the candidate must have the ability and strong desire to “make things happen”.
• Must have a results-oriented work ethic and a positive, can-do attitude. Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be “hands on”.
• Must have the highest personal values and ethical standards.

This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30% of work time.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.