Vice President Medical & Scientific Strategy - Immunology

About the Role

The Medical Scientific Strategist (MSS) is the marquee medical and scientific expert in Novotech, The MSS possesses deep therapeutic area expertise, medicine development experience, and scientific thought leadership. Key responsibilities of this role include collaborating with business development to develop trusted advisor relationships with our sponsor clients through medical and therapeutic strategy expertise, leading to increased RFPs and awards; cultivating peer to peer relationships with sponsor CMOs, external KOLs, and PIs; and developing and enhancing Novotech’s scientific reputation through thought leadership and external speaking engagements.

The Medical Scientific Strategist (MSS) partners with business development, clinical operations, medical services, regulatory and drug development consulting teams to design scientifically sound, operationally feasible and integrated, competitive commercially aligned clinical programs.

The MSS represents Novotech’s medical and scientific expertise externally through interactions with peers in sponsors, academics and investigational sites, as well as through publications and speaking opportunities.

Responsibilities

• Provide deep therapeutic and scientific leadership for protocol design, and scientific advisory interactions, ensuring alignment with current global standards of care and late-stage development trends.
• Serve as primary therapeutic and development expert for client-facing proposals, bid defenses, and early study concept development, delivering therapeutic rationale, risk/mitigation strategies, and competitive landscape insight.
• Build and maintain relationships with clients, KOLs, principal investigators, and high-performing clinical sites.
• As required, support investigator identification and site selection strategies to optimize enrolment and data quality.
• Contribute as a leader of therapeutic science defining project medical strategy and scope while acting as resource to operational stream work of timelines, budgets, vendor selection and monitoring plans. Undertaking a critical review of the RFP, proposed project outline and any other available resource.
• Advise cross-functional teams on regulatory strategy, endpoint selection, safety monitoring and comparator standards to meet payer and label expectations.
• Mentor and upskill internal colleagues on therapeutic area science and clinical development best practices; contribute to thought leadership and capability building across the CRO.
• Maintain currency of expertise by proactively undertaking 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.
• Proactively seek out new prospects to expand Novotech’s business opportunities, including existing/ new clients, investigational site referrals and vendors.
• Attend meetings with potential new clients providing clinical, therapeutic and drug development expertise to discussions on new business (pre-award) opportunities. Obtain an understanding of the client’s key drivers and corporate strategy to ensure the most appropriate study and pipeline design is developed with optimal utilization of competitive landscape, practicing status, regulatory strategic positioning, expertise of PIs and KOLs in the development of a 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 strategy aligned with client objectives and operational success is proposed in the RFP response.
• Represent Novotech at external events. These may include Bid Defense Meetings, KOL engagement visits, site/ vendor meetings, professional association, scientific conferences.
• Review and revise the therapeutic, 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.
• Collaborate with BD and Sales Operations, 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 Management (PM) and other Novotech departments.
• Lead as strategic partner at every stage of clinical development to sponsors and internal stakeholders navigate evolving evidence and emerging risks and clinical development decisions to maximize success.
• Serve as the primary clinical development expert, advising across development stages, and providing clinical development leadership.

• Opportunity and MSS capability/experienced based assignment including; stage of development, modality, clinical development complexity, sponsor stakeholder level, regulatory experience, or KOL/PI needs.

Experience and Qualifications

• Medical Doctor (MD) or equivalent medical degree in the United States.

• Significant experience (typically 15+ years) in a medical role in industry (large pharm, biotech, CRO)

• Significant industry experience in medicines development, ideally including both early and late-phase clinical program leadership or advanced therapeutic strategy roles within a sponsor, academic center, or CRO.
• Demonstrated track record of scientific credibility with KOLs, investigators, and clinical sites in the specified therapy area.
• Experience contributing to commercial-facing bids and study design, with ability to balance scientific rigor against operational and commercial constraints.
• Excellent communication skills, collaborative approach, learning agility, and comfort with ambiguity.

• Senior positions should hold significant industry experience on regulatory interactions as medical lead across early-to-late-stage development including significant number of NDA and BLA submissions.

Expected Salary Range: $340,000 to $380,000 USD – Salary offered will be based on candidates experience level.

Find out more about working at Novotech at: www.novotech-cro.com/careers

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.