About the role:

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 Director 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.

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 prioritize, meet deadlines and able to work well in teams across time-zones.
At least 7-15 years’ clinical research experience, including role as a Project Manager or Senior Project Manager or equivalent, in a CRO, biotech or equivalent environment where you have demonstrated ability to develop clinical and operational strategy in oncology studies.

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 Defence 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:

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.
Proactively seek out new prospects to expand Novotech’s business opportunities, including existing/ new clients, CRO and other vendors, and investigational site referrals.

Additional Responibilities:

Establish a therapy area of expertise globally (or a subset of indications in a Therapy area) and have demonstrated the ability to grow that area of business through past performance.
Becoming the subject matter expert for both internal and external customers.
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.

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 Defence 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:

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.
Proactively seek out new prospects to expand Novotech’s business opportunities, including existing/ new clients, CRO and other vendors, and investigational site referrals.

Additional for Senior Therapeutic Strategy Manager / Therapeutic Strategy Director

Establish a therapy area of expertise globally (or a subset of indications in a Therapy area) and have demonstrated the ability to grow that area of business through past performance.
Becoming the subject matter expert for both internal and external customers.
Identifying new business opportunities associated with that TA.
Provide mentorship to junior members of the team.

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:

Associate Therapeutic Strategy Manager: At least seven years experience in clinical research, including at least 2 years of clinical trial management as a PM in clinical trial industry.
Therapeutic Strategy Manager: At least seven years clinical research experience, including role as a Project Manager or Senior Project Manager or equivalent, in a CRO, biotech or equivalent environment where you have demonstrated ability to develop clinical and operational strategy.
Senior Therapeutic Strategy Manager: At least ten years clinical research experience, including role as a Project Manager or equivalent, in a CRO, biotech or equivalent environment where you have demonstrated ability to develop clinical and operational strategy and have the ability to lead a subset of the Therapy Area.
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 with the ability to own and grow commercially a TA at Novotech.

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.