Therapeutic Strategy Manager

5 months ago

Kuala Lumpur, Malaysia Novotech Asia Full time

**Reporting to**: As indicated on current organisation chart.

**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 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**:
**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 analyse 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 utilising CTMS Feasibilitymodule, taking into consideration protocol, IMP, regulatory and therapy area/indication specificities.
- Utilise 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 defence 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/ Director**
- 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 stra

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