Job Description

Brief Position Description:

The responsibilities of Therapeutic Strategy encompass both Business Development (BD) and Clinical Operations, having a key role in the development of new business opportunities for Novotech, providing clinical, therapeutic and operational expertise to repeat and potential new clients. In partnership with BD-Sales and the client, Therapeutic Strategy team members have a pivotal role in the development of new and repeat business opportunities to drive revenue growth and deliver customer-focused outcomes.
Therapeutic Strategy team members liaise directly with clients, Clinical Research Organization (CRO) vendors, investigators and study site staff globally to ensure Novotech presents the best country, site, therapeutic and operational strategy for each new business opportunity.

The ideal candidate will have the following experience:

• Experience at a Project Manager or Project Director role, or equivalent, in global vaccine clinical trials.
• Detailed understanding of the end-to-end clinical trial process of early phase through late phase.
• Sound understanding and working relationship with vaccine KOLs and sites - Who / Where / Why / What / How
• Experience working in either a CRO or Biotech company working with vaccines.

Minimum Qualifications & Experience:

Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. Must be able to communicate clearly, able to prioritise, meet deadlines and able to work well in teams across time-zones.

Preferably experience of working in clinical research, pharmaceutical/biotechnology industry or a related field per role level as follows:

• Therapeutic Strategy Specialist: At least three years\' experience in clinical research as a Clinical Research Associate, Study Coordinator or equivalent.
• Senior Therapeutic Strategy Specialist: At least five years\' experience in clinical research, including at least 2 years of clinical trial management, site identification and/or feasibility experience.
• Therapeutic Strategy Manager: At least seven years clinical research experience, including role as a Project Manager or equivalent, in a CRO, biotech or equivalent environment.
• Senior Therapeutic Strategy Manager: At least ten years clinical research experience, including role as a Senior Project Manager or equivalent, in a CRO, biotech or equivalent environment.
• Therapeutic Strategy Director: At least fifteen years clinical research experience, including role as a Project Director or equivalent, in a CRO, biotech or equivalent environment.

Responsibilities

• Build profitable business relationships with clients, Key Opinion Leaders (KOLs), investigators, site staff and vendors.
• On all assigned opportunities, ensure a thorough understanding of the requirements, scope and client expectations; undertaking a critical review of the Request For Proposal (RFP), proposed project outline and any other available resources. Proactively undertake additional self-learning on the therapy area, investigational product and standard of care as required. Perform review of scientific literature, commercial databases and internal tools where required to support the development of the clinical strategy for new opportunities.
• Attend meetings with potential new clients providing clinical, therapeutic and operational expertise to discussions on new business (pre-award) opportunities. Obtain an understanding of the client\'s key drivers to ensure the most appropriate sites and countries are considered in the development of an operational and clinical strategy for each assigned opportunity. Liaise directly with clients, CRO and other vendors, investigators, and study site staff as required to ensure a robust therapeutic and operational strategy is proposed in the RFP response.
• Critically review results from pre-award feasibility on an ongoing basis and amend feasibility strategy as needed to ensure robust clinical solution is developed and presented to clients.
• Proactively seek out new prospects to expand Novotech\'s business opportunities, including existing/ new clients, investigational site referrals and vendors.
• Represent Novotech at external events where requested. These may include Bid Defense Meetings, KOL engagement visits, site/ vendor meetings, professional association, scientific conferences. Be mindful of the role of ambassador for Novotech when conducting day to day business.
• Participate in BD handover meetings to Novotech Therapeutic team.

Level Specific Responsibilities:

Therapeutic Strategy Specialist/ Senior Specialist

• Lead and oversee the pre-award feasibility process on assigned opportunities, working with Novotech Country Managers, in-country feasibility teams and CRO vendors, ensuring timely response. Critically review and analyze data received during feasibility process and amend strategy as required in consultation with the Therapeutic Strategy Manager/Director.
• Propose clinical region and site strategy for Manager/Director review and suggest additional regions/sites for consideration where appropriate.
• Develop tailored study specific feasibility questionnaire utilizing CTMS Feasibility module, taking into consideration protocol, IMP, regulatory and therapy area/indication specificities.
• Utilize reporting tools and provide regular updates to internal team and client. Prepare reports/ presentation for dissemination to the client and/or input data to support proposed strategy into proposal and bid defense materials as required.
• Senior Specialist: May be appointed to lead feasibility process for complex opportunities, Tier A clients and potentially large value/high probability projects across a wide range of therapeutic areas. Provide mentorship to junior members of the team.

Therapeutic Strategy Manager/ Senior Manager

• Review and revise the therapeutic, operational and clinical strategy sections of the proposal and Executive Summary, as needed, to ensure the proposal is specific to the opportunity, addresses the requirements of the client and as outlined in the RFP, and clearly defines Novotech\'s proposed strategy for successful delivery of the project. Overall responsibility for final output of the following sections of the proposal of assigned opportunities: Executive Summary, feasibility, country and site strategy, timelines and recruitment initiatives.
• Collaborate with BD-Sales, Proposals, Budgets and Contracts (PBC) team, functional heads/designees and CRO Vendor(s) (as applicable) to develop the study budget, providing input into timelines, study specific requirements and identification of any needed vendor quotes.
• Collaborate with BD-Sales, PBC, assigned functional teams and CRO Vendor(s) (as applicable) to define a strategy for Bid Defense meetings and provide input into presentation materials. Attend and present at Bid Defense meetings in collaboration with BD-Sales, Project Manager (PM) and other Novotech departments.
• Collaborate with Novotech internal (e.g. Novotech laboratory, SMO) and external partners to propose their inclusion in the therapeutic and operational strategy for new business opportunities.
• Initiate, lead and implement process improvement initiatives within the Therapeutic Strategy group.
• Senior Manager: May be appointed to large, high potential value and complex multi-national opportunities across a wide range of therapy areas. Proactively seek out new prospects to expand Novotech\'s business opportunities, including existing/ new clients, CRO and other vendors, and investigational site referrals. Establish a therapy area of expertise, becoming the subject matter expert for both internal and external customers and identifying new business opportunities associated with that TA. Provide mentorship to junior members of the team.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.