Job Description
What you'll be doing The Senior Manager, Medical Information and Medical Capabilities, will report to the Director, Medical Capabilities and will be a critical member of the Medical Affairs team. This individual will provide integral Medical Information & Medical Capabilities support across Nuvation Bio's pipeline which includes serving as the medical reviewer on the MLR committee, leading the development of Medical Information deliverables, and overseeing the Independent Medical Education (IME) grant review process.
You will be responsible for...Medical Information - Serve as an active member of the Medical Affairs team, providing relevant Medical Information insights and metrics to inform the overall strategy as well as ensuring Medical Information activities are aligned with medical plans as appropriate
- Lead the development, review, maintenance, and approval of Medical Information materials, including Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and custom responses
- Manage Medical Information operations, vendor oversight, budget, and compliance activities to ensure the delivery of timely, accurate, scientifically balanced, and regulatory-compliant medical information
- Ensure the call center is fully trained on content availability and escalation processes
- Ensure all MI content is scientifically rigorous, balanced and aligned with the quickly evolving data
- Partner with Medical Information vendors and cross-functional stakeholders, including Pharmacovigilance, Clinical, and Medical Strategy, to support medical inquiry responses and compliance adherence and regulatory readiness.
- Alongside Director Medical Capabilities, manage Medical Information metrics, quality indicators, and inquiry trends, and contribute to process improvements, SOP development, training initiatives, and operational excellence activities.
Medical Review and Governance- Serve as the Medical reviewer within the Medical, Legal, and Regulatory (MLR) review processes, providing scientific leadership and medical oversight for promotional and non-promotional materials.
- Lead medical accuracy review and provide strategic scientific input to ensure materials are accurate, balanced, evidence-based, and aligned with approved data, medical strategy, and applicable regulations.
- Collaborate with cross-functional stakeholders to facilitate timely review and approval of materials while maintaining scientific integrity and alignment with approved data and medical strategy.
- Support the development and continuous improvement of MLR review processes, guidance documents, and best practices to enhance consistency, compliance, and operational effectiveness.
- Serve as MLR Coordinator for medical affairs content, ensuring pieces are reviewed and approved in a timely manner to meet business needs.
Medical Affairs Capabilities- Serve as business owner for Medical Affairs website, overseeing content, review coordination, maintenance, and ongoing optimization to ensure accurate, compliant, and user-focused medical content.
- Manage operations of IME grant reviews and approvals, including running monthly Grant Review Committee meetings.
- Support other medical capabilities projects as needed, as aligned with Director Medical Capabilities, team needs, and to support individual professional development.
What Knowledge & Experience you'll bring to us...- Advanced degree (MD, PhD, PharmD) in a medical or science-related specialty, although significant experience in a scientific field may be considered in lieu of an advanced degree
- 3+ years [AP1] [EP2] [EP3] of direct experience in Medical Information and MLR in a biotech/pharmaceutical industry required
- Oncology experience required; experience in lung cancer and/or neuro-oncology preferred
- 3+ years of direct experience in Medical Information
- An equivalent combination of education and experience may be considered
- Familiarity with Veeva Promomats and Veeva CRM preferred
- Self-directed and motivated with the decisiveness and flexibility necessary to operate successfully in a complex, dynamic environment.
- Proven track record of matrix teamwork, timely decision making, prioritization, and results oriented mindset in successfully achieving objectives.
- Exhibits advanced knowledge of Medical Information work and processes, and the applicable industry guidance and regulations.
- Proficiency in medical writing and medical content creation; able to correctly understand, interpret, and accurately communicate scientific data.
- Experience conducting medical accuracy reviews for promotional and medical materials.
- Demonstrated strong verbal, written, and presentation skills.
- Excellent interpersonal, and communications skills with attention to detail
- 20% domestic and international travel to headquarters and to medical conferences, as needed
- Ability to work onsite regularly as needed
Behavioral skills to be successful...- Problem-Solver - As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Emotional intelligence, curiosity, and a knack to figure out a way to build something better
- Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
- Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
- Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you! - Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
DisclaimerThis job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing AgenciesAll of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
