- Vice President/Executive Director of Busines Development (BD)
- Head of Clinical Development/Sr. Medical Director
- Sr. Director/Director, Clinical Development and Medical Affairs
Vice President/Executive Director of Busines Development (BD)
Vice President of Business Development will help build Oncolys’s presence in the United
States. Vice President of Business Development is a key position within Oncolys’s Global Business Development team and will lead all Oncolys’s activities around Business Development, including licensing, partnering strategies, assessment, and due diligence.
With responsibilities for therapeutics business development, alliance management, and project management, Vice President of Business Development will be instrumental in helping to shape Oncolys’s future by 1) identifying, negotiating, and closing new therapeutics business development opportunities to advance Oncolys’s clinical development plan, 2) providing validated market intelligence to help drive target selection strategy, and 3) managing new alliance & partner relationships.
- Vice President of Business Development will lead Oncolys’s activities in the U.S., including intelligence gathering of our key targets for licensing out, forming partnering strategies with market potential and competitive landscape assessment, and preparing for business approach.
- Rapidly gain an appreciation of the benefits and deep understanding of the science surrounding Oncolytic viral therapies (OVTs) & COVID-19 therapies, their unique advantages, and potential in the treatment of Cancer & COVID-19.
- Build awareness of Oncolys Oncolytic viral platform in the wider market and promote awareness & interest within key pharmaceutical companies.
- Inform Oncolys management of the market’s needs and interests in Oncolys’s Pipeline, such that the company can direct its R&D effort accordingly.
- Originate, negotiate, close, and manage key strategic alliances in the U.S. to advance clinical plans. Analyze competitors’ deals and see comparable transactions.
- Develop, lead, and coordinate all due diligence steps with pharmaceutical companies. Propose terms and work with legal counsel in OBP.
- Develop a partnering strategy that supports Oncolys USA R&D strategies including identifying and triaging opportunities consistent with the agreed strategy, leading cross-functional due diligence teams to assess opportunities, negotiating and executing deals of all types (out-licensing, in-licensing, research collaborations) across the R&D and commercial pipeline with Global BD team.
- In first 6 months, build a pipeline of relationships (minimum 3) that result in potential deal flow and also within next 6 months, secure a new therapeutic licensing transaction, in addition to having a number of other potential collaboration deals in the pipeline.
- In a timely manner, prepare CDAs & term sheets and manage transaction negotiations in partnership with Oncolys’s leadership, board, in-house legal counsel and required external advisors.
- Lead team by working directly with internal and external key opinion leaders and operational leadership within Business Development, and Oncolys R&D including Strategic Academic Alliances.
- Proactively monitor commercial, academic, and IP landscapes for all external discovery and development-stage innovations which may be relevant to the Oncolys’s pipeline and provide an appropriate competitive intelligence service to the company, including leading scouting and partnering interactions at key conferences.
- Partner with the leadership team and organization at-large in prospecting for and helping to drive research alliances and preclinical and clinical collaborations with external parties (e.g., pharmaceutical or biotech companies, academic or not-for-profit institutions) that will enhance Oncolys’s pipeline and commercial opportunities.
- Lead technical evaluation and due diligence efforts where appropriate.
- Contribute to establishing and maintaining key opinion leader contacts across an appropriate range of therapeutic areas.
- Prepare and present scientific and business rationale for any recommendations and transaction proposals to senior management for approval.
- Identify, evaluate, and transact BD opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization.
- Negotiate on behalf of Oncolys in support of in-licensing, out-licensing, co-promotions, research collaborations, etc.
- Support Oncolys project teams (discovery, development, CMC, legal) on partnering activities in terms of technical expertise and due diligence.
Expose Oncolys to US investors
- Add credibility and contribute valuable perspective to leadership team decision making and board presentations.
- At all times, act as an ambassador for the company to all internal and external audiences of relevance, including investors/potential investors.
Position Requirements & ExperienceCandidates will possess many or all of the following attributes
- MS in Biology/Engineering/Life Science required. Preferred PhD, MBA, and appropriate licenses in the US in compliance with US regulators including US Patriot Act.
- A strong technical/scientific understanding and ideally have experience across a range of therapeutic areas.
- A strong track record of success in complex and global deal negotiations along with a successful track record in business development and a proven ability to initiate and close transactions, ideally with a focus on early-stage transactions, i.e., preclinical, Phase I-II clinical.
- At least 5-10 years’ exposure to, and a good understanding of the life sciences R&D environment and knowledge of all stages of pharmaceutical development. Significant experience in Healthcare Operations, Finance and Business Development is important.
- Candidates may have started their career in “big pharma” and should understand how such companies operate. This knowledge will be complimented by experience of working in a small biotechnology company, where the focus is on external promotion of that company.
- Experience in healthcare biotech financing with institutional investors, high net worth individuals and retail investors is highly desirable.
- Deep understanding of drug development, approval, and commercialization processes.
- Must demonstrate scientific knowledge and gravitas to hold/drive meaningful scientific discussions with industrial and academic experts and key opinion leaders in Oncology/IO.
- A well-established commercial/academic network within industry is strongly preferred, along with a progressive knowledge of innovative alliance structures, industry trends, and competitive issues related to pharmaceutical business development.
- Results-oriented, creative, self-starter with the ability to deliver high-quality deliverables on time that are appropriate for review by senior management.
- Strong verbal and written communication and presentation skills.
- Excellent interpersonal skills including a demonstrated ability to be effective in a matrix environment.
- Requires up to 40% travel.
- Location: remote-based with HQ in Edison, New Jersey.
Personal Characteristics & Cultural Fit
- High energy with the ability to thrive in the challenging and fast paced environment of a young and fast-growing company.
- Strong team player and excellent interpersonal skills with ability to work cross-functionally throughout Oncolys.
- Results-oriented and self-motivated with the desire and ability to proactively take initiative and make things happen.
- High level of attention to detail.
- Accomplished and pragmatic decision-maker.
Head of Clinical Development/Sr. Medical Director
The Head of Clinical Development / Senior Medical Director, Early Clinical Development, Oncolytic viral therapy , will lead/support conduct of clinical studies and will play a key leadership role in clinical development programs of Oncolys BioPharma, including being accountable for deliverables of the assigned program(s), resourcing, budget and timelines. May serve as scientific and medical lead for clinical team(s) working closely with operational lead. May assume leadership responsibility for a large section/indication of a development plan, or an entire asset development plan. May provide strategic scientific and clinical foresight, insight, and oversight for therapeutic candidates about to enter clinical experiments, and s/he will collaborate with the corporate partner clinical teams, providing medical and scientific support for the programs and communication with the medical community, establishing Oncolys as a key and competitive player. S/he will also work effectively with regulatory agencies both in the U.S. and internationally.
The Head of Clinical Development/Sr. Medical Director is expected to develop and maintain relationships with KOLs on global scale, represent Clinical Development internally to senior management, as well as externally to KOLs, Lead advisory board meetings, responsible for the oversight of scope, schedule , resources of the programs and for the recommendation of strategic context and priorities to senior management. He or she will provide clinical input on clinical protocol development, regulatory issues, and patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, as well as presentation of data at national and international meetings. In addition, he or she will provide medical oversight to all Oncolys Programs and will serve as sponsor medical monitor on sponsored clinical trials. This position will have a strong outward facing presence and will support Oncolys investigator-initiated trials programs. This is an integral role in the provision of successful product development in support of Oncolys Drug development efforts.
The Head of Clinical Development/Sr. Medical Director is a physician, preferably Board-Certified. The ideal candidate will have history of clinical and translational research and some industry experience in Oncology. experience in all aspects of clinical trials. The ideal candidate should have significant experience in their medical specialty and would thrive on proactively engaging internal and external leaders and will serve as a medical expert for their compound(s) and/or disease area. He or she will have strong commercial aptitude and/or experience, including proven ability to translate and appropriately align commercial and scientific goals and objectives.
S/he will have solid peer relationships with external scientific and clinical experts in Oncology. The individual must have the ability to work independently and also as an effective and engaged team member in a fast- paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Contributes to the development of the early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints, etc.
- Facilitates/leads the cross-functional study team on the following activities, including but not limited to:
- Designs POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per clinical strategy.
- Responsible for the relevance and accuracy of medical science underpinning of clinical study based on thorough scientific review and consultation with internal and external experts.
- Reviews, edits and finalizes clinical trial plans
- Organizes and conducts consultations with global opinion leaders
- Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments.
- Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
- Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study teams.
- Accountable, with input from Clinical Trial Management and Biostatistics and Data Management for timely clinical trial execution and quality of deliverables:
- Leads and supervises the Clinical Team to produce high quality program deliverables on schedule
- Identifies program, trial or data risks, creates and implements mitigation strategies
- Maintains and develops relationship with key study investigators
- Organizes clinical expert consultations, steering committees and data safety monitoring boards as required
- Reports to Oncolys management on clinical trial findings and milestones
- Responsible for the medical content of clinical study reports
- Reviews all medical/scientific publications related to clinical trial
- Analyzes the benefits and risk aspects of an assigned therapeutic candidate:
- Responsible for the analysis of clinical data, including safety monitoring
- Responsible for activities and procedures that ensure patient safety
- Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
- Authors/contributes to clinical sections of communications/documentation for regulatory agencies and is a key contributor in meetings with agencies.
- Demonstrated capability to supervise and mentor less experienced personnel.
- Identifies and recommends resource allocation for CDP execution
- Identifies changes to established practices/policies if appropriate
- Identifies potential opportunities for optimal resource allocation
- Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives.
- Primary Responsible, takes lead on major/significant collaborations with Oncolys BioPharma partners ( PIs, academic centers etc.) to understand current and emerging targets/molecule program, provide clinical input on potential disease areas/indications, and design clinical experiments that corroborate or inform the biology for decision-making purposes.
- M.D. degree. Board Certification/Eligibility in a relevant therapeutic area preferred, along with relevant industry experience, (MD/Ph.D. preferred)
Experience and skill requirement:
- 5+ years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials.
- Experience with FDA Advisory Panels with knowledge of the international regulatory and clinical development process is desirable.
- Successful history preparing and filing INDs and NDAs/BLAs resulting in drug approvals both in the US and preferably ex-US is desirable.
- Significant clinical trial experience in relevant therapeutic area assigned will be a positive asset; other associated relevant therapeutic area experiences may be acceptable and evaluated on case by case basis.
- Breadth and ability to be adaptable and work with appropriate foresight and forward thinking.
- Excellent communications skills (verbal and written); capable of articulating the Company's clinical strategies and results to worldwide audiences.
- Ability and strong desire/drive to "make things happen." A results-oriented work ethic, a positive, can-do attitude, and a proven ability to build an effective organization by attracting and retaining high caliber personnel.
- Intellectually curious with a passion for developing innovative pharmaceutical drugs. Creative, "thinks outside the box," willing to take responsible risks.
- Effective leadership, people management, a team builder style and a global orientation are essential.
- Must have highest personal values and ethical standards.
Sr. Director/Director, Clinical Development and Medical Affairs
Role serves as an established, internal scientific/medical expert for therapeutic area, contributing to US medical strategy in collaboration with other functions that drive early and later stage clinical development and medical affairs activities in support of the early and late-stage development portfolio in immuno-oncology.
This role is also a strong partner and influencer of the global pipeline strategy.
Contributes to and oversees the execution of this strategy across Oncolys USA primarily through the development of the product strategy and the translation of this product strategy into a highly impactful US medical plan with the goal to medically support maximizing the number of appropriate patients participating in Oncolys IIST and company sponsored studies.
Provides expert medical/scientific advice and guidance to support the needs of internal partners for designated therapeutic area (e.g., Clinical Operations, Translational planning, Legal, Regulatory, Corporate etc.). Supports therapeutic area strategy and planning through working with external parties and internal leaders. Continually seeks to increase market awareness and expertise by developing relationships with outside organizations/experts to support research programs, clinical development programs, and life cycle management. This includes, but not limited to, supporting the strategy for local Medical Advisory Board and Expert Panel meetings, Medical Grants, External Collaborative Research, and Medical Publications.
This role requires an individual with strong communication and leadership skills, as well as the ability to build strong relationships with key stakeholders ( including in our corporate HQ in Japan) in R&D, Medical Affairs, Business Development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific partner who can readily bridge between a cutting-edge research environment and a fast-paced clinical and product development organization. The successful candidate is expected to actively drive effective clinical development and medical affairs activities and to represent the department and programs at internal and external meetings.
- Provide exceptional scientific expertise and collaboration within the medical team, to your peers within the group, and to the organization in general.
- Contribute to the formation, refinement and execution of medical strategies and tactics including early Phase 1b/2 and late- stage 2/3 including Investigator-Initiated Study and/or company sponsored studies and ensure medical plans optimally are integrated into Life Cycle Management (LCM) though appropriate collaborations
- Serves as a liaison by representing the company with key external stakeholders including Healthcare Providers, Payors, Professional Organizations and Patient Advocacy Groups. Works to understand the evolving healthcare investigator sites, cooperative groups, professional societies in oncology, patient groups, and external consultants.
- Establishes and maintains relationships with key opinion leaders,
- Charged with determining the scientific objectives and ensuring creation of content (post-meeting conference summaries, new relevant TA data), and ensuring staff are adequately trained and informed of Oncolys USA, competitor data and TA strategy.
- Contribute to the development of a strategic and robust Medical Advisory Board plan that aims to enhance product knowledge and to inform on clinical practice patterns and gaps
- Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
- Assist in the preparation publications of clinical study date and maintain a publication plan for our oncology portfolio.
- Possesses deep therapeutic area/scientific knowledge and in-depth knowledge of medical affairs and clinical development. Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific objectives and business objectives of the Therapeutic Area Section
- Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
- Excellent oral and written communications with ability to present data to all levels of audiences.
- Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Strong capable of strategic thinking and proposing innovative solutions to issues.
- Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.
This position is individual contributor
Position Type and Expected Hours of Work
The regular office hours are 8 hours per day. The official workweek for Full Time STAFF is Forty (40) hours per week.
15% Travel is expected for this position to include domestic and global travel
Required Education and Experience
- Doctoral degree (e.g., PhD, MD, DO) or doctoral degree in pharmacy preferred.
- Eight-plus (8+) years of experience in clinical and/or academic practice or six-plus (6+) years industry experience in clinical development or medical affairs.
- Planning and executing Medical Affairs and/or Clinical Development strategy, clinical trials, regulatory submissions and a demonstrated ability to collaborate across non-medical functions (e.g., Business development , Legal, , Regulatory, etc.).
- Ability to effectively work independently and in a multidisciplinary team.
- Demonstrated business acumen with ability to balance need for maintaining high scientific standards with business relevance and impact.
- Demonstrated ability to establish strong customer relationships.
- Knowledge of healthcare and regulatory environment.
- Working knowledge of, and experience with, clinical trial design , Investigator-Initiated Trials, conduct, data acquisition and reporting.
- Working knowledge of Clinical Drug Development .
- Experience leading projects and ability to motivate/lead others
- Strategic thinking and agility to respond to market events.
- Strong analytical, oral and written communication skills.
- Excellent time management skills and be able to work well under pressure.
- Demonstrates high ethical and profession standards with all internal and external working relationships.
- Accountability, agility, and innovative thinking.
Additional Eligibility Qualifications
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take COVID-19 vaccine and post-offer physical (if required).
- Oncolys USA Inc. is an Equal Opportunity Employer, and offers a comprehensive benefits package including health, dental, vision, 401k, paid vacation (PTO)
- Competitive base salary commensurate with role and experience