Director, Medical Affairs

Job Title: Director, Medical Affairs

Location: Menlo Park, CA

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies in the following NSCLC indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (HARMONi)
• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (HARMONi-3

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Overview of Role:

The Director, Medical Affairs is a key member of the Medical Affairs team, responsible for supporting the development of and the execution of high-impact scientific activities and materials. They. will be the lead for all operational standards, platforms, and practices for the global Medical Affairs department (GMA), with a focus on scientific engagements and data generation projects. This individual is a subject matter expert in running, documenting, and reporting on multiple types of GMA offerings and is a strategic partner to the GMA leadership in their annual strategic planning and ongoing evaluation and reporting of such plans implementations.

Role and Responsibilities:

• Responsible for support for the GMA strategies and goals and ensures their successful implementation:

• Support the development and tracking of goals and objectives for the Medical Affairs department, including evaluation and utilization of different analysis and visualization techniques and platforms.

• Support the development and tracking of the annual departmental budget, including providing foresight for multiyear budget planning.

• Direct all operational aspects of Summits global Investigator Sponsored Trials (IST) program and provide end-to-end process to include planning discussions, protocol development, contract execution, fair market value evaluations, and ongoing oversight of projects budgets and execution.

• Organize and develop the scientific content for the IST Scientific Review Committee meetings as a member of the cross-functional committee

• Manage the development of the IST platform and the management of the operational aspects of the system

• Work closely with regulatory, safety and IMP cross-functional teams on the management of the IST program

• Manage Master Service Agreements (MSAs); Statements of Work (SOWs); and Vendor Management Plan development

• Support all GMA aspects of Summits cooperative collaboration trials. Provide end-to-end process to include planning discussions, contract execution, vendor management, and ongoing oversight of projects budgets and execution.

• Development of operational standards for future activities governed by GMA

• Participation in Cross-Functional teams and manage an end-to-end process to include planning discussions, contract execution, vendor management for all Medical Affairs projects, medical grants and sponsorships.

• Provide strategic operations leadership for all key strategic Medical Affairs programs as it relates to research support, educational offerings, cross-functional initiatives, and projects, and forward-looking operational planning.

• Oversee Fair Market Value evaluations for prospective consultants.

• Remain abreast of new operations standards, platforms and practices and champion best practice adoption by Summit GMA.

Experience, Education and Specialized Knowledge and Skills:

• Advanced degree (PhD or equivalent) in life sciences or related field highly preferred, candidates with a masters degree in life sciences and extensive relevant experience will be considered.

• Minimum of 8 years of experience in a relevant role within the pharmaceutical industry required, a strong focus in oncology preferred.

• Strong clinical/scientific acumen required including the ability to interpret, analyze, organize, and communicate scientific data.

• Strong interpersonal and communication skills with the ability to work effectively in a cross-functional, matrixed organization.

• Experience working with KOLs, and academic institutions is a plus.

• IST management experience preferred

• Ability to interact with senior management, academic experts, and patient advocates appropriately, with confidence and ease.

• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools.

• Strong computer and database skills

• Attention to detail, accuracy, and confidentiality.

• Excellent organizational skills

• Critical thinking, problem solving, ability to work independently.

• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.

• Work in a fast-paced, demanding, and collaborative environment.

The pay range for this role is at the Director level is $231,000 to $261,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits human resources department to obtain prior written authorization before referring any candidates to Summit.